Randomization as a method of experimental control has been extensively used in human clinical trials and other biological experiments. It prevents the selection bias and insures against the accidental bias. It produces the comparable groups and eliminates the source of bias in treatment assignments. Finally, it permits the use of probability theory to express the likelihood of chance as a source for the difference of end outcome. This paper discusses the different methods of randomization and use of online statistical computing web programming (www.graphpad.com/quickcalcs or www.randomization.com) to generate the randomization schedule. Issues related to randomization are also discussed in this paper.

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Determining the optimal sample size for a study assures an adequate power to detect statistical significance. Hence, it is a critical step in the design of a planned research protocol. Using too many participants in a study is expensive and exposes more number of subjects to procedure. Similarly, if study is underpowered, it will be statistically inconclusive and may make the whole protocol a failure. This paper covers the essentials in calculating power and sample size for a variety of applied study designs. Sample size computation for single group mean, survey type of studies, 2 group studies based on means and proportions or rates, correlation studies and for case-control for assessing the categorical outcome are presented in detail.

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Infertility and problems of impaired fecundity have been a concern through ages and is also a significant clinical problem today, which affects 8-12% of couples worldwide. Of all infertility cases, approximately 40-50% is due to "male factor" infertility and as many as 2% of all men will exhibit suboptimal sperm parameters. It may be one or a combination of low sperm concentration, poor sperm motility, or abnormal morphology. The rates of infertility in less industrialized nations are markedly higher and infectious diseases are responsible for a greater proportion of infertility. The present literature will help in knowing the trends of male factor infertility in developing nations like India and to find out in future, various factors that may be responsible for male infertility.

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A thin endometrium is encountered infrequently (2.4%) in assisted reproductive technology cycles. When it does occur it is a cause of concern as it is associated with lower implantation rate and pregnancy rate. Though pregnancies have been reported at 4 and 5 mm it is apparent that an endometrial thickness <6 mm is associated with a trend toward lower probability of pregnancy. Hormone replacement therapy – frozen embryo transfer (FET) cycles appear to give better results due to an improvement in endometrial receptivity (ER). The etiology of thin endometrium plays a significant part in its receptivity. A number of treatments have been tried to improve endometrial growth, but none has been validated so far. Confirming ER of a thin endometrium by an ER array test before FET offers reassurance.

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Adolescence, derived from the Latin word "adolescere" meaning "to grow up" is a critical developmental period. During adolescence, major biological as well as psychological developments take place. Development of sexuality is an important bio-psycho-social development, which takes an adult shape during this period. During adolescence, an individual's thought, perception as well as response gets colored sexually. Puberty is an important landmark of sexuality development that occurs in the adolescence. The myriad of changes that occurs in adolescents puts them under enormous stress, which may have adverse physical, as well as psychological consequences. Understanding adolescent sexuality has important clinical, legal, social, cultural, as well as educational implications.

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Aims and Objectives : To evaluate the role of endometrial thickness, pattern and sub-endometrial blood flows measured by 2D power Doppler ultrasound to predict pregnancy during in-vitro fertilization (IVF) treatment. Study Design : Prospective, non-randomized clinical study. Materials and Methods : This was a prospective observational study. A total of 101 infertile women were recruited from our IVF-ET program from January to December, 2009. Women with tubal factor, male factor and unexplained infertility were included in the study. Results : The mean age was 35 years and mean duration of infertility was 8 years. Seventy five (74.25%) patients had primary infertility and 26 (25.74%) had secondary infertility. The mean endometrial thickness was 8.1 mm and endometrial blood flow was in Zone I in 18 patients, 28 patients had blood flow in Zone II and 54 had in Zone III. Overall, 27 (26.73%) patients conceived and in these women the endometrial thickness was between 6 and 12 mm. Conclusions : With a thin endometrium (≤7 mm) and no-triple-line endometrial pattern coexisting in an in-vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) candidate, cryopreservation should be recommended. With a thin endometrium and a good texture (triple-line), other prognostic factors, such as embryo quality, should be taken into account. The endometrial vascularity has a useful predictive value on the implantation rate in IVF cycles irrespective of the morphological appearance of the endometrium. However, further study is needed to make a definitive conclusion.

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Background: Infertility is a complex disorder with significant medical, psychological and economic problems. Aims: The aim of the study is to evaluate the structural abnormalities of the uterus and fallopian tubes in infertile women as elucidated by hysterosalpingography. Setting and Design: A retrospective study, conducted at the Radiology and Obstetric and Gynaecologic Departments of a tertiary health care institution. Materials and Methods: Evaluation of all consecutive patients in whom hysterosalpingographic (HSG) was performed for infertility between July 2013 and June 2015 in the Department of Radiology. For the biodata, indications for the investigation and the HSG findings were obtained. Statistical Analysis: The data were analyzed using IBM Statistical Package for the Social Sciences (SPSS Inc., Chicago, IL, USA) for Windows, version 20 software. Results: A total of 299 patients were evaluated. Of these, 250 were for infertility with primary and secondary infertility constituting 18.4 and 81.6%, respectively. Seventy percent of the cases for infertility had abnormalities on the HSG. Normal uterine cavity was found in 123 (49.2%) cases. Uterine filling defects were the most common uterine abnormality. Fallopian tube occlusion, loculated contrast material spillage and hydrosalpinx were more common on the right, and bilateral tubal occlusion was seen only in 11.2%. All cases of intravasation were associated with either unilateral or bilateral fallopian tube blockage or irregularity of the uterus. Conclusion: There was a high incidence of tubal disease in the women presenting with infertility. This was commonly as a result of infection and inflammatory process. This study showed that HSG is very vital in detecting birth canal pathologies; hence, the facility for this important procedure, especially fluoroscopy, should be made available in the health centres for adequate assessment of the women with infertility.

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Background: Polycystic ovary syndrome (PCOS), the major endocrinopathy among reproductive-aged women, is not yet perceived as an important health problem in the world. It affects 4%–20% of women of reproductive age worldwide. The prevalence, diagnosis, etiology, management, clinical practices, psychological issues, and prevention are some of the most confusing aspects associated with PCOS. Aim: The exact prevalence figures regarding PCOS are limited and unclear. The aim of this review is to summarize comprehensively the current knowledge on the prevalence of PCOS. Materials and Methods: Literature search was performed through PubMed, ScienceDirect, Cochrane Library, and Google Scholar (up to December 2019). All relevant articles published in English language were identified following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Results: Our analysis yielded 27 surveys with a pooled mean prevalence of 21.27% using different diagnostic criteria. The proportion of women with PCOS also increased in the last decade. Conclusion: The current review summarizes and interprets the results of all published prevalence studies and highlights the burden of the syndrome, thereby supporting early identification and prevention of PCOS in order to reverse the persistent upward trend of prevalence.

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Prolactin (PRL) is an anterior pituitary hormone which has its principle physiological action in initiation and maintenance of lactation. In human reproduction, pathological hyperprolactinemia most commonly presents as an ovulatory disorder and is often associated with secondary amenorrhea or oligomenorrhea. Galactorrhea, a typical symptom of hyperprolactinemia, occurs in less than half the cases. Out of the causes of hyperprolactinemia, pituitary tumors may be responsible for almost 50% of cases and need to be investigated especially in the absence of history of drug induced hyperprolactinemia. In women with hyperprolactinemic amenorrhea one important consequence of estrogen deficiency is osteoporosis, which deserves specific therapeutic consideration. Problem in diagnosing and treating hyperprolactinemia is the occurrence of the 'big big molecule of prolactin' that is biologically inactive (called macroprolactinemia), but detected by the same radioimmunoassay as the biologically active prolactin. This may explain many cases of very high prolactin levels sometimes found in normally ovulating women and do not require any treatment. Dopamine agonist is the mainstay of treatment. However, presence of a pituitary macroadenoma may require surgical or radiological management.

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Fallopian tubes make a vital portal for transfer of gametes and embryo. Tubal factor is responsible for infertility in 25-35% of cases. Hysterosalpingography (HSG) has been used to evaluate the uterine cavity and the tubal status since decades. It uses iodinated contrast and X-rays and is painful and inconvenient for patient. Laparoscopy is considered to be the gold standard for tubal evaluation, but is an operative procedure and needs anesthesia. Though ultrasound is a modality of choice for assessment of uterus and ovaries, it does not allow assessment of the fallopian tube unless there is any fluid surrounding it or inside the lumen. This fluid interface can be created artificially by introducing saline in the uterine cavity and fallopian tubes and scanning simultaneously. The procedure is named Saline infusion HSG. Saline infusion sonohysterosalpingography (SIS) can be done with B mode US and Doppler. SIS can demonstrate a patent tube but if blocked, the site of block cannot be demonstrated. Ultrasound contrast agents can be used for tubal assessment using contrast mode on the scanners. This procedure is known as hystero-contrast sonography (HyCoSy). This actually shows the passage of hyperechoic contrast agent through tubal lumen and delineates it and locates the site of block. Using the volume ultrasound may even make the demonstration of tubal status and fimbriae better. Results of HyCoSy have been found to correlate well with laparoscopic findings, which are a gold standard. It is recommended by National Institute for Health and Clinical Excellence as a primary investigation for tubal assessment in patients without any positive history of tubal damage and also can replace a second look laparoscopy.

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The process of sperm maturation, capacitation, and fertilization occur in different molecular milieu provided by epididymis and female reproductive tract including oviduct. The different tissue environment with different oxygen tension and temperature may still influence the process of sperm maturation and capacitation. Reactive oxygen species (ROS) is reported to be an initial switch that may activate the molecular process of capacitation. Therefore, the generation of reactive oxygen species and its possible physiological role depends upon a balance between its formation and degradation in an open environment provided by female reproductive tract. The sensitivity of the spermatozoa to the action of ROS may be due to its exposure for the first time to an oxygen rich external milieu compared to its internal milieu in the male reproductive tract. Reduced temperature in testicular environment coupled with reduced oxygen tension may be the right molecular environment for the process of spermatogenesis and spermiogenesis. The morphologically mature spermatozoa then may attain its motility in an environment provided by the caput epididymis wherein, the dyenin motor can become active. This ability to move forward will make the spermatozoa physiologically fit to undertake its sojourn in the competitive race of fertilization in a new oxygen rich female reproductive tract. The first encounter may be oxygen trigger or preconditioning of the spermatozoa with reactive oxygen species that may alter the spermatozoal function. Infertility is still one of the major global health problems that need medical attention. Apart from the development of artificial methods of reproduction and development of newer techniques in the field of andrology focuses attention on spermatozoal structure and metabolism. Therefore, understanding the molecular mechanisms involved in fertilization in general and that of sperm capacitation in particular may help lead to new and better techniques for enhancing fertility, identifying and treating certain forms of male infertility, and preventing conception. One remarkable insight is the importance of membrane cholesterol efflux in initiating transmembrane signaling events that confer fertilization competence. The identity of the physiologically relevant cholesterol acceptors and modulators of cholesterol efflux is therefore of great interest. Still, it is clear that cholesterol efflux represents only a part of this story. The involvement of phospholipid translocation in mediating dynamic changes in the membrane, rendering it conducive to transmembrane signaling, and the modulation of membrane components of signal transduction cascades by cholesterol or phospholipids will yield important insights into the links between environmental sensing and transmembrane signaling in the sperm. Understanding the membrane molecular events will ultimately provide new and exciting areas of investigation for the future.

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Human implantation is a complex process requiring synchrony between a healthy embryo and a functionally competent or receptive endometrium. Diagnosis of endometrial receptivity (ER) has posed a challenge and so far most available tests have been subjective and lack accuracy and a predictive value. Microarray technology has allowed identification of the transcriptomic signature of the window of receptivity window of implantation (WOI). This technology has led to the development of a molecular diagnostic tool, the ER array (ERA) for diagnosis of ER. Use of this test in patients with recurrent implantation failure (RIF) has shown that the WOI is displaced in a quarter of these patients and use of a personalized embryo transfer (pET) on the day designated by ERA improves reproductive performance. Our results in the Indian population revealed an endometrial factor in 27.5% RIF patients, which was significantly greater than the non-RIF group 15% (P = 0.04). After pET, the overall ongoing pregnancy rate was 42.4% and implantation rate was 33%, which was at par with our in-vitrofertilization results over 1-year. We also performed ERA in patients with persistently thin endometrium, and it was reassuring to find that the endometrium in 75% of these patients was receptive despite being 6 mm or less. A pregnancy rate of 66.7% was achieved in this group. Though larger studies are required to validate these results ERA has become a useful tool in our diagnostic armamentarium for ER.

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INTRODUCTION: The present study was performed to assess the safety and feasibility of a new laparoscopic entry site in cases suspected of adhesions due to previous surgery. MATERIALS AND METHODS: It is a retrospective study undertaken at a tertiary care referral center for advanced gynecological laparoscopic surgery from January 2011 to December 2014. RESULTS: In 624 patients with a history of previous abdominal surgeries, the laparoscopic entry site was through a newly devised point. It is a point in the left paraumbilical region at the level of umbilicus, in a straight line drawn vertically upward from a point 2.5 cm medial to anterior superior iliac spine. Intra-abdominal adhesions were found in 487 (78.0%) patients, and umbilical adhesions in 404 (64.7%) patients with past abdominal surgeries. CONCLUSION: There were no significant entry-related, intra-operative, or postoperative complications with the use of this entry point. It is also suitable as a main working port during the course of surgery.

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Dhat syndrome has often been construed as a culture-bound sexual neurosis of the Indian subcontinent. Symptoms similar to that of Dhat syndrome has been described in other cultures across different time periods. The present paper looks at the evolution of the concept of Dhat syndrome in India. The review also takes an overview of the current understanding of this syndrome in terms of nosological status as a distinct entity and its "culture-bound" status. The narrative finally attempts to discuss the integrated approach for the treatment of this disorder.

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Empty follicle syndrome (EFS) is an uncommon, but the frustrating complication of assisted reproductive technology with failure to obtain oocytes after an adequate ovarian response to stimulation. Most of the reported cases of EFS are drug-related problems which are actually avoidable and do not represent any potential pathology and that the risk of genuine EFS (GEFS) is much smaller than was once thought. Our case is thefirst report of a pregnancy obtained after management of GEFS with dual trigger in a gonadotropin-releasing hormone (GnRH) antagonist cycle. In this report, we present a patient who underwent two oocyte retrievals, in which no oocytes were obtained. In the third in-vitrofertilization cycle, a dual trigger with the combination of GnRH agonist and human chorionic gonadotropin yielded 11 oocytes, which led to the transfer of 2 blastocysts resulting in a live birth. Changing the treatment protocol with dual trigger brought about a successful outcome.

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The rising prevalence of obesity has had a profound impact on female reproductive health. Increased body mass index (BMI) is associated with ovulatory subfertility and anovulatory infertility. Overweight and obese women have poorer outcomes following fertility treatment. They respond poorly to clomiphene induction of ovulation and require higher doses of gonadotrophins for ovulation induction and superovulation. Ovarian stimulation for assisted reproduction produces fewer follicles resulting in the harvest of fewer oocytes. Fertilization rates are poorer and the embryo quality is impaired in younger women who are obese. Pregnancy rate in some studies is lower and there is an increased risk of early pregnancy loss. Weight loss regularizes menstrual cycles and increases the chance of spontaneous ovulation and conception in anovulatory overweight and obese women. Gradual sustained weight loss is beneficial whereas crash dieting is detrimental.

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Current evidence links oxidative stress (OS) to male infertility, reduced sperm motility, sperm DNA damage and increased risk of recurrent abortions and genetic diseases. A review of PubMed, Medline, Google Scholar, and Cochrane review databases of published articles from years 2000–2018 was performed focusing on physiological and pathological consequences of reactive oxygen species (ROS), sperm DNA damage, OS tests, and the association between OS and male infertility, pregnancy and assisted reproductive techniques outcomes. Generation of ROS is essential for reproductive function, but OS is detrimental to fertility, pregnancy, and genetic status of the newborns. Further, there is a lack of consensus on selecting OS test, type, and duration of antioxidants treatment as well as on the target patients group. Developing advanced diagnostic and therapeutic options for OS is essential to improve fertility potential and limit genetic diseases transmitted to offspring.

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Context: Effects of zinc on male sexual competence are poorly understood. Aim: To study the effects of different doses of zinc on the sexual competence of males using a rat model. Materials and Methods: Three subsets (eight in each subset) of sexually experienced adult male rats were supplemented with three different oral doses of zinc sulphate (a daily dose of 1 mg, 5 mg and 10 mg respectively) for two weeks. A subset of eight animals without zinc supplementation was used as the control group Sexual behavior was observed by placing them individually in cages with receptive females. Statistical Analysis : Data analysis was done using SPSS v10 for windows computer software. Results: Supplementation of 5 mg of zinc/day for two weeks led to a prolongation of ejaculatory latency; 711.6 sec. (SEM 85.47) vs. 489.50 sec. (SEM 67.66), P< 0.05 and an increase in number of penile thrusting; 52.80 (SEM 11.28) vs. 26.50 (SEM 6.17), P< 0.05, compared to controls. The same group had elevated prolactin (PRL) and testosterone (T) levels compared to controls at the end of treatment period; PRL- 7.22 ng/dl (SEM 3.68) vs. 2.90 ng/dl (SEM 0.34) and T- 8.21 ng/ml (SEM 6.09) vs. 2.39 ng/ml (SEM 1.79), P< 0.05. In contrast, reduction of libido was evident in the same group, but this effect was not statistically significant ( P> 0.05). However, partner preference index was positive and 5 mg zinc supplementation did not exert a significant adverse effect on the muscle strength and co-ordination. The subset of rats supplemented with 1 mg/day did not show a difference from the control group while supplementation with 10 mg/day led to a reduction of the libido index, number of mounts and intromissions. Conclusions : Zinc therapy improves sexual competence of male rats; the effect is dose dependent. Increase in the T levels is beneficial in this regard. However, increase in PRL is responsible for the reduced libido index. Further studies on pigs and monkeys are needed to evaluate the therapeutic use of zinc in sexual dysfunction.

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Luteinizing hormone (LH) in synergy with follicle stimulating hormone (FSH) stimulates normal follicular growth and ovulation. FSH is frequently used in assisted reproductive technology (ART). Recent studies have facilitated better understanding on the complementary role of the LH to FSH in regulation of the follicle; however, role of LH in stimulation of follicle, optimal dosage of LH in stimulation and its importance in advanced aged patients has been a topic of discussion among medical fraternity. Though the administration of exogenous LH with FSH is obligatory for controlled ovarian stimulation in patients with hypogonadotropic hypogonadism, there is still a paucity of information of its usage in other patient population. In this review we looked in to the multiple roles that LH plays complementary to FSH to better understand the LH requirement in patients undergoing ART.

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Background: Polycystic ovary syndrome (PCOS) is known to be associated with insulin resistance and anti-Mullerian hormone (AMH), leading to the use of insulin-sensitizing agents (ISAs) to manage PCOS. Metformin is the most widely used ISA to treat irregular menstruation; however, the gastrointestinal side effects are quite debilitating. The development of herbal medicines such as bioactive fraction DLBS3233 offers a possibly effective treatment with minimal side effects. Aim: To determine the effect of metformin and DLBS3233 on serum AMH level. Materials and Methods: This study was a double-blind, randomized, controlled trial conducted between March 2013 and June 2015 at Yasmin Clinic, RSCM Kencana, Jakarta and Hasan Sadikin Hospital, Bandung. The patients with PCOS were diagnosed using the Rotterdam criteria. All participants received daily treatment consisting of 1500 mg metformin divided into two doses or 100 mg DLBS3233 for 6 months. An evaluation of serum AMH level was conducted before and after the completion of therapy. Results: Twenty patients received metformin, whereas 18 patients received DLBS3233. The levels of AMH prior to the intervention were 9.30 ± 5.06 ng/mL and 11.27 ± 6.47 ng/mL. After 6 months of therapy, we found that the decrease in AMH level was higher in the metformin group compared to the DLBS3233 group (ΔAMH = 1.83 ng/mL, P = 0.003 and ΔAMH = 1.15 ng/mL, P = 0.077, respectively). However, more side effects were observed in the metformin group compared to the DLBS3233 group (P = 0.01). A total of seven patients (18.42%) were confirmed as pregnant during the study. Conclusion: There was a significant decrease in the serum AMH level after administration of either metformin or DLBS3233.

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The androgen insensitivity (testicular feminization) syndrome was described by Morris in phenotypic females with 46XY karyotype, presenting with primary amenorrhea, adequate breast development, and absent or scanty pubic or axillary hair. Gonads consist usually of seminiferous tubules without spermatogenesis. These patients have a 5-10% risk of developing germ cell tumors, usually after the complete development of secondary female sexual characteristics. We hereby report a case considered as a female with married life of 15 years, who was operated for severe abdominal pain. Phenotype characters were that of female. Microscopic examination of the tumor from the abdomen revealed germinoma and yolk sac tumor with adjacent seminiferous tubules. Karyotyping showed 46XY. Final diagnosis of malignant mixed germ cell tumor in androgen insensitivity syndrome was made. Surveillance may be the most appropriate option when these conditions are initially diagnosed in adulthood to prevent development of germ cell tumors.

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Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic complication of assisted reproduction technology. The syndrome is characterized by cystic enlargement of the ovaries and a fluid shift from the intravascular to the third space due to increased capillary permeability and ovarian neoangiogenesis. Its occurrence is dependent on the administration of human chorionic gonadotrophin (hCG). β-hCG and its analogs, estrogen, estradiol, prolactin, histamine and prostaglandins have all been implicated in OHSS but now it is increasingly better understood that the vasoactivesubstances such as interleukins, tumor necrosis factor-α, endothelin-1, and vascular endothelial growth factor (VEGF) secreted by the ovaries have been implicated in increasing vascular permeability. Enlargement of the ovaries causes abdominal pain, nausea and vomiting. Leakage of fluid from follicles, increased capillary permeability leading to third spacing (due to the release of vasoactive substances), or frank rupture of follicles can all cause ascites. Due to leakage of fluid through the impaired blood vessels both within and outside the ovary there is massive fluid-shift from the intra-vescular bed to the third compartment results in intravascular hypovolemia with concomitant development of edema, ascites, hydrothorax and/or hydropericardium. Low-dose gonadotrophin protocols have been implemented to reduce the risks of fertility treatment in polycystic ovary syndrome patients. Prophylactic albumin administration may interrupt the development of OHSS by increasing the plasma oncotic pressure and binding mediators of ovarian origin. OHSS is significantly lower in an antagonist protocol than in an agonist protocol. Cabergoline inhibits partially the VEGF receptor 2 phosphorylation levels and associated vascular permeability without affecting luteal angiogenesis reduces the 'early' (within the first 9 days after hCG) onset of OHSS. To prevent thrombosis, subcutaneous heparin 5000-7500 U/d is begun on the first day of admission. These patients need a hospital ward where the clinical picture is well understood and the personnel have expertise in its treatment and follow-up. Admission to an intensive care unit is necessary when critical OHSS develops.

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Recurrent miscarriages are postimplantation failures in natural conception; they are also termed as habitual abortions or recurrent pregnancy losses. Recurrent pregnancy loss is disheartening to the couple and to the treating clinician. There has been a wide range of research from aetiology to management of recurrent pregnancy loss. It is one of the most debated topic among clinicians and academics. The ideal management is unanswered. This review is aimed to produce an evidence-based guidance on clinical management of recurrent miscarriage. The review is structured to be clinically relevant. We have searched electronic databases (PubMed and Embase) using different key words. We have combined the searches and arranged them with the hierarchy of evidences. We have critically appraised the evidence to produce a concise answer for clinical practice. We have graded the evidence from level I to V on which these recommendations are based.

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In a woman with severe Asherman's syndrome, curettage followed by placement of intrauterine contraceptive device (IUCD) (IUCD with cyclical hormonal therapy) was tried for 6 months, for development of the endometrium. When this failed, autologous stem cells were tried as an alternative therapy. From adult autologous stem cells isolated from patient's own bone marrow, endometrial angiogenic stem cells were separated using immunomagnetic isolation. These cells were placed in the endometrial cavity under ultrasound guidance after curettage. Patient was then given cyclical hormonal therapy. Endometrium was assessed intermittently on ultrasound. On development of endometrium with a thickness of 8 mm and good vascularity, in vitro fertilization and embryo transfer was done. This resulted in positive biochemical pregnancy followed by confirmation of gestational sac, yolk sac, and embryonic pole with cardiac activity on ultrasound. Endometrial angiogenic stem cells isolated from autologous adult stem cells could regenerate injured endometrium not responding to conventional treatment for Asherman's syndrome.

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