Several countries have in recent years introduced prescribed requirements for treatment and monitoring of outcomes, as well as a licensing or accreditation requirement for in vitro fertilization (IVF) clinics and their laboratories. It is commonplace for Assisted Reproductive Technology (ART) laboratories to be required to have a quality control system. However, more effective Total Quality Management systems are now being implemented by an increasing number of ART clinics. In India, it is now a requirement to have a quality management system in order to be accredited and to help meet customer demand for improved delivery of ART services. This review contains the proceedings a quality management session at the Indian Fertility Experts Meet (IFEM) 2010 and focuses on the creation of a patient-oriented best-in-class IVF laboratory.

Objective: Nonalcoholic fatty liver disease (NAFLD) and polycystic ovary syndrome (PCOS) both are known to be associated with insulin resistance and metabolic syndrome (MS). The aim of the study was to determine the presence of NAFLD and associated factors of hepatic steatosis in women with PCOS. Materials and Methods: A cross-sectional hospital based study of 54 women with PCOS and 55 healthy controls who were age and weight matched were included. Anthropometric parameters, biochemical and hormonal investigations were done in all the patients. Insulin resistance was calculated by Homeostasis model assessment (HOMA). Abdominal ultrasonography and biochemical tests were used to determine the presence of hepatic steatosis after excluding other causes liver disease. Results : Women with PCOS had a higher prevalence of hepatic steatosis (67% vs 25%, P = 0.001) MS (35% vs. 7%, P < 0.01) and elevated transaminases (31% vs. 7%, P = 0.03) than controls. All patients with PCOS and controls with MS had presence of hepatic steatosis. Age, BMI, waist-hip ratio, HOMA-IR, HDL and PCOS diagnosis were the factors associated with presence of hepatic steatosis. Conclusion : NAFLD is commonly present in women with PCOS in combination with other metabolic derangements. Evaluation for liver disease should be considered at an earlier age in women with PCOS, particularly those who have an evidence of MS.

Background: Polycystic ovary syndrome (PCOS) is the commonest endocrinopathy in women that is associated with reproductive and metabolic disorders. Objectives: We compared the ovulation and conception rates after the treatment with clomiphene citrate (CC) alone and in combination with metformin in infertile patients presented with polycystic ovarian syndrome (PCOS). Materials and Methods: This randomized controlled trial of independent cases and controls was conducted at the Department of Obstetrics and Gynecology, Hera General Hospital, Makkah, Saudi Arabia from February 01 to December 31, 2008. The 42 subjects diagnosed as PCOS were divided into group A and B (21 subjects in each) for management with CC + metformin and CC alone, respectively. Group A received 500 mg three times a day of metformin continuously from the first cycle for 6 months or till pregnancy was confirmed. In both groups CC was started at a dose of 50 mg from day-2 till day-6 of the menstrual cycle. The dose of CC was increased to 100 mg in second and 150 mg in third cycle, and then remained 150 mg for the remaining three cycles. With ovulation the dose of CC was unaltered in both groups. Data were analyzed using Statistical Package for the Social Sciences (SPSS) version 16. Results: More than 50% females in both groups were had body mass index > 25. Group A achieved high rate of regular cycles, ovulation success, and conception than group B (71.4% vs. 38.1%; P = 0.03), (76.2% vs. 38.1%; P = 0.021), and (66.6% vs. 28.6%; P = 0.01), respectively. Conclusion: Management with metformin + CC increased the ovulation and conception rates.

Aim: This study aimed to evaluate the efficacy of ketotifen on sperm motility of asthenospermic infertile men. Setting and Design: It is a prospective study designed in vivo. Materials and Methods: In this interventional experimental study, a total of 40 infertile couples with asthenospermic infertility factor undergoing assisted reproductive technology (ART) cycles were enrolled. The couples were randomly assigned to one of two groups at the starting of the cycle. In control group (n = 20), the men did not receive Ketotifen, while in experiment group (n = 20), the men received oraly ketotifen (1 mg Bid) for 2 months. Semen analysis, under optimal circumferences, was obtained prior to initiation of treatment. The second semen analysis was done 2-3 weeks after stopped ketotifen treatment and sperm motility was defined. Clinical pregnancy was identified as the presence of a fetal sac by vaginal ultrasound examination. Statistical Analysis Used: All data are expressed as the mean ± standard error of mean (SEM). t test was used for comparing the data of the control and treated groups. Results: The mean sperm motility increased significantly (from 16.7% to 21.4%) after ketotifen treatment (P < 0.001). This sperm motility improvement was more pronounced in the primary infertility cases (P < 0.003). The rate of pregnancy was 12.5% in infertile couples that their men receiving 1 mg/twice a day ketotifen. In 52% of infertile men's semen, the percentage of sperm motility was increased from 5% to 35% and this sperm motility improvement was also observed in 33% of necrospermia (0% motility) cases. Conclusion: These results suggest that ketotifen may represent as a novel therapeutic approach to improve sperm motility in the infertile men with cause of asthenospermia or necrospermia.

Aim: To evaluate whether semen processing at 37°C yield sperm with better DNA integrity compared to centrifugation and processing at room temperature (RT) by swim-up method. Settings: This study was done at tertiary care center attached to Reproductive Medicine Unit and Medical College. Design: Prospective pilot study. Patients: Normozoospermic men (n = 50) undergoing diagnostic semen analysis. Materials and Methods: Normozoospermic samples (World Health Organization, 2010 criteria) after analysis was divided into two aliquots (0.5 mL each); one was processed at 37°C and the other at RT by swim-up method. DNA fragmentation of both samples post wash was calculated by acridine orange method. Statistical Analysis Used: The values of sperm DNA fragmentation were represented as mean and standard error (mean ± SEM) of the mean. Paired t-test was used for calculating the sperm DNA integrity difference between post wash at RT and 37°C. Results: Statistically significant difference was not observed in post wash sperm DNA fragmentation values at 37°C compared to RT. Conclusion: Our data represents that there was no significant difference in sperm DNA fragmentation values of samples processed at 37°C and at RT. Hence, sperm processing at 37°C does not yield sperm with better DNA integrity compared to centrifugation and processing at RT.

Objective: The objective of this study was to test the hypothesis that AMH and antral follicle count (AFC) are good predictors of ovarian response to controlled ovarian stimulation and to compare them. Materials and Methods: This observational cross-sectional study included 56 subjects aged between 25 and 42 years who were enrolled between 1 ^st January and 31 ^st December 2010 for their first intracytoplasmic sperm injection (ICSI) program. Baseline hormone profiles including serum levels of Estradiol (E2), Follicle-stimulating hormone (FSH), Luteinizing hormone (LH), and Anti-mullerian Hormone (AMH) were determined on day 3 of the previous cycle. The antral follicle count measurements were performed on days 3-5 of the same menstrual cycle. Antral follicles within the bilateral ovaries between 2-6 mm were recorded. The subjects were treated with long protocol for ovarian stimulation. Ovulation was induced with 10,000 IU of human chorionic gonadotropin (hCG) when at least 3 follicles attained the size of more than 17 mm. Transvaginal oocyte retrieval was performed under ultrasound guidance 36 hours after hCG administration. An oocyte count less than 4 and absence of follicular growth with controlled ovarian hyper stimulation was considered as poor ovarian response. Oocyte count of 4 or more was considered as normal ovarian response. Results: Statistical analysis was performed using SPSS software trail version 16.0. Subjects were divided into 2 groups, depending on the ovarian response. The mean oocyte counts were 12.27 ± 6.06 and 2.22 ± 1.24 in normal and poor responders, respectively, ( P = 001). Multiple regression analysis revealed AMH and antral follicle count as predictors of ovarian response (β coefficient ± SE for AMH was 1.618 ± 0.602 ( P = 0.01) and for AFC, it was, 0.528 ± 0.175 ( P = 0.004). AFC was found to be a better predictor of ovarian response compared to AMH in controlled ovarian hyper stimulation. Conclusion: The observations made in this study revealed that both AMH and AFC are good predictors of ovarian response; AFC being a better predictor compared to AMH.

Objective: To determine the role of diagnostic hysterolaparoscopy in the evaluation of infertility in tertiary care centres. Materials and Methods: This retrospective study was conducted at two tertiary care centres (the infertility clinics of Sriram Chandra Bhanj Medical College and Prachi hospital at Cuttack, Odisha) throughout the year in 2008. Women aged 20-40 years with normal hormone profile without male factor infertility were included. Results: Out of 300 cases, 206 (69%) patients had primary infertility. While laparoscopy detected abnormalities in 34% of the cases, significant hysteroscopy findings were noted in 18% of cases. Together, diagnostic hysterolaparoscopy detected abnormalities in 26% of the infertile patients in both groups. While the most common laparoscopic abnormality was endometriosis (14%) and adnexal adhesion (12%) in primary and secondary infertile patients, respectively, hysteroscopy found intrauterine septum as the most common abnormality in both groups. Conclusions: Hysterolaparoscopy is an effective diagnostic tool for evaluation of certain significant and correctable tubo-peritoneal and intrauterine pathologies like peritoneal endometriosis, adnexal adhesions, and subseptate uterus, which are usually missed by other imaging modalities.

Background: Submucosal myomas are associated with infertility and may be treated by hysteroscopic resection. Objective: The aim of this retrospective study was to analyze 37 subfertile patients who unnderwent hysteroscopic myomectomy in a tertiary care center with particular regard to their postprocedure reproductive outcome. Materials and Methods: The entire patient group (n = 37) underwent the procedure between March 2004 and March 2010. The submucosal myomas were type 0 (n = 27), type 1 (n = 8), and type 2 (n = 2). The mean myoma size was 2.1 cm; mean duration of the procedure was 54 mins and mean follow-up was 26 ΁ 10 months. 22 patients had one or more associated infertility factors. Results: The complication rate was 5.4%. 11 patients (29.7%) conceived after the procedure. The pregnancy rate was better when myoma was the exclusive etiology of infertility (40%), when the myoma was completely intracavitary (33.3%), when the lesion was ≥ 30 mm in size (50%), and there were no associated intramural fibroids. Conclusion: Hysteroscopic myomectomy is a safe procedure to enhance fertility especially in cases with unexplained infertility.

Objectives: The use of nicotine through smoking remains a serious health problem. It has been associated with reduced fertility, although the mechanism responsible is still unclear. The present study was designed to investigate whether nicotine-induced infertility is associated with altered male reproductive hormones in male albino rats. Materials and Methods: Forty male rats were divided equally into five groups and treated orally for thirty days. Group I, which served as the control received 0.2 ml/kg normal saline, Group II and III received 0.5 mg/kg (low dose) and 1.0 mg/kg (high dose) body weight of nicotine, respectively. The fourth and fifth groups were gavaged with 0.5 mg/kg and 1.0 mg/kg body weight of nicotine but were left untreated for another 30 days. These groups served as the recovery groups. Serum was analyzed for testosterone, luteinizing hormone (LH), follicle stimulating hormones (FSH), and prolactin using radioimmunoassay. Results: Results showed that nicotine administration significantly decreased (P < 0.05) testosterone in the low and high treated groups and FSH in the high dose treated group when compared with the control group. There was a significant increase (P < 0.05) in mean LH and prolactin level in the high dose treated group when compared with the control. However, the values of the recovery groups were comparable with the control. Conclusion: The findings in this study suggest that nicotine administration is associated with distorted reproductive hormones in male rats although ameliorated by nicotine cessation. It is plausible that the decreased testosterone level is associated with testicular dysfunction rather than a pituitary disorder.

Objectives: Removal of an ovary of any side of the body is called the unilateral ovariectomy (ULO). ULO models are used to analyze the existence of functional and physiological asymmetries between the ovaries, including the ovum implantation. Materials and Methods: ULO was done in mice without any specification on their stages of the estrous cycle. The animals were mated between 3 ^rd and 15 ^th day after ULO to observe the consequence of ULO on ovulation and ovum implantation. Results: Ovulation and number of implantation were decreased in proportion to single contralateral ovary if the animals were mated within 36 hrs of ULO. It resulted in increased weight of contralateral ovary due to hypertrophy, and also in compensatory ovulation, formation of corpus luteum (CL) that reached a peak after 14 ^th and 15 ^th day of ULO (sacrificed on 5 ^th day of pregnancy i.e., 19 ^th and 20 ^th day of ULO) compared to animals undergone sham-surgery. Numbers of implantations were also increased progressively on the contralateral ovarian side and get to a peak after similar days of compensation. Discussion and Conclusion: Following ULO, the remaining ovary started to compensate within 5 ^th to 6 ^th day of ULO even during pregnancy. Ovarian histology also showed increased formation of CL which is a marker of rate of ovulation.

Aim: The aim of this study is to compare ovarian response, oocyte, embryo quality, ovarian hyperstimulation syndrome incidence, and pregnancy rates in polycystic ovary syndrome (PCOS) and non-PCOS group. Materials and Methods: This was a prospective observational study on PCOS carried out in seven assisted reproduction centers in India between August 2008 and July 2010, as part of trial under the Indian Society of Assisted Reproduction. A total of 192 women (77 in the PCOS group and 115 in the non- PCOS group) undergoing in vitro fertilization/intracytoplasmic sperm injection were included. All women had long protocol and recombinant follicle-stimulating hormone stimulation. Analysis: The mean number of follicles and oocytes was higher in PCOS group compared with non-PCOS, being 27.2 (±8.8) and 13.6 (±5.3); 15.9 (±6.3) and 10.9 (±6.2), respectively. The recovery rates of oocytes and mature oocytes per follicle were less in the PCOS group which was 64% and 61.1%, respectively as opposed to 80.3% and 74.5%, respectively in non-PCOS group. The total numbers of top-quality embryos were less in the PCOS group. Conclusion: In PCOS women though the number of follicles was more, recovery of mature oocytes, top-quality embryos was less. Pregnancy rates were comparable in both groups.

Aims: A variety of stress factors are known to inhibit male reproductive functions. So this study was conducted in order to investigate the effects of honey and vitamin E on the germinative and somatic cells of testes of rats exposed to noise stress. Materials and Methods: Mature male wistar rats (n0 = 24) were randomly grouped as follows: Group 1 (honey + noise stress), 2 (vitamin E + noise stress), 3 (noise stress,) and 4 as the control group. In groups 1, 2, and 3, rats were exposed to noise stress. In groups 1 and 2, rats also were given honey and vitamin E, respectively, orally for 50 days. After that, the germinative and somatic cells of testes parenchyma were isolated by digesting the whole testes by a standard method. Next, viability, apoptosis, and necrosis of the cells were evaluated by TUNEL kit and flow cytometry. Results: The rates of apoptosis and necrosis of the testicular cells were increased (P = 0.003 and P = 0.001, respectively), but viability of these cells decreased in testes of rats exposed to noise stress (P = 0.003). However, administration of honey and vitamin E were significantly helpful in keeping the cells of testis parenchyma alive, which suffers from noise pollution (P < 0.05 and P < 0.05, respectively). Conclusions: Noise stress has negative influences on the cells of testicular tissue by increasing apoptotic and necrotic cells. However, the associated enhancement in healthy cells suggests that honey and vitamin E have positive influences on the testis parenchyma.

Objectives: The literature regarding clinical outcomes following day 5/6 vitrified warmed blastocysts transfer has been conflicting. We decided to evaluate and compare the clinical outcomes following vitrified warmed day 5/6 blastocyst transfer using a solid surface vitrification protocol with fresh blastocyst transfers. Settings: University teaching hospital. Study Design: A total of 249 women were retrospectively analyzed: 146 fresh day 5 blastocyst (group 1), 57 day 5 vitrified warmed blastocyst (group 2), and 46 vitrified warmed day 6 blastocyst (group 3) transfer cycles. Vitrification was done using solid surface methodology (non immersion protocol). The main outcomes were implantation rates, clinical pregnancy, and live birth rate per embryo transfer. Results: The baseline clinical characteristics were similar among all three groups. The implantation and clinical pregnancy rates following vitrified warmed day 6 blastocyst transfers (20.9% and 32.6%) were significantly lower as compared to day 5 fresh and vitrified warmed day 5 blastocyst transfers (40.3% and 56.1%, 36.3%, and 52.6%). However, there was no significant difference in the live birth rates across the three groups (group 1: 37.6%, group 2: 40.3%, and group 3: 28.2%). Conclusion: No statistically significant difference was observed in live birth rates between fresh day 5 blastocyst transfers and vitrified warmed day 5/6 blastocyst transfers. Vitrification of blastocysts using solid surface methodology is an efficient method of cryopreservation.

Background: Embryo transfer (ET) technique is one of the important factors of in vitro fertlization success. Among the different steps in ET technique, less attention has been given to embryo loading (EL). The aim was to compare the impact of two different techniques of EL on pregnancy rate in IVF/ET cycles. Materials and Methods: In this retrospective study, 144 and 170 patients were placed in groups A and B, respectively. In Group A, the embryos were drawn directly into the ET catheter from culture microdrop under the oil. In Group B, the embryos were transferred from culture microdrop into G2 medium in center-well dish. Then, the embryos were drawn into the catheter and finally transferred into the uterus. Both groups were adjusted for other parameters based on the EL technique. The main outcome measure was pregnancy rate. Results: There were insignificant differences for etiology of infertility, source of sperm, type of stimulation protocol, percent of IVF or intracytoplasmic sperm injection type of ET catheter, cycles with good quality embryos and transferred embryos between two groups. The rate of both chemical and clinical pregnancy was higher in Group B compared to A, but the difference was insignificant (P = 0.09 and P = 0.1, respectively). Conclusion: It seems that there is no difference in the outcome by loading the embryo from microdrop or center-well dish.

Objectives: The objective was to highlight the frequency, clinical profile, and predisposing factors of ectopic pregnancy (EP) in a general hospital. Materials and Methods: This descriptive study was conducted at the Obstetrics and Gynaecology department of Hera General hospital, Makkah, Saudi Arabia, from July 1, 2009 to December 29, 2010. Data were collected on chief medical complaints, sociodemographic characteristics, past obstetrics and gynecological history, management done, and outcome of management. Data were analyzed using Microsoft Office Excel (version 2007). Results: Out of total 7564 pregnancies, 44 (0.58%) patients were diagnosed as EP. Out of 44, 22 (50%) patients presented within 24 h of onset of symptoms. Mean age was 28 ± 7 years. Multigravida were predominant in 25 (57%), and 21 (48%) had gestational age of 6-8 weeks at the time of presentation; the common presenting features were amenorrhea (41, 93.2%), abdominal pain (39, 88.6%), and tenderness (38, 86%). Previous pelvic surgery (13, 29.5%), infertility treatment (11, 25%), and pelvic inflammatory disease (10, 22.7%) were the common predisposing factors. Twenty-five (57%) presented with ruptured EP and were operated within 24 h, and the remaining were kept under observation till further diagnosis. After confirming the diagnosis, 12/19 underwent laparoscopy, whereas 7/19 received medical treatment. Surgery confirmed fallopian tube pregnancies in 35 (94.5%). No mortality was observed. Conclusion: Previous pelvic surgeries were the major etiological factor for EP. Other factors were infertility treatment and pelvic inflammatory disease. The most common site of EP was fallopian tubes.

The isolated, complete, transverse vaginal septum is one of the most infrequent anomalies of the female genital tract, and when it coexists with a septate uterus, it is even rarer. This report describes a case of transverse vaginal septum with septate uterus. A 12-year-old girl sought medical assessment because of severe cyclic lower abdominal cramping and pelvic pain. Local examination revealed a blind vaginal pouch of 2 cm and on rectal examination a tender pelvic mass was noted. Radiological examination showed transverse vaginal septum in the lower vagina with bicornuate uterus. Surgical resection of the vaginal septum was done under laparoscopic guidance. Hysteroscopy revealed presence of uterine septum which was resected by a resectoscope. Post-operative dilatation of vagina was done to prevent restenosis. Laparoscopic guided abdominoperineal approach is better in such a case as multiple mullerian anomalies may coexist with each other.

In a conventional IVF cycle unexpected complete fertilization failure may occur in 10-25% of infertile women. To overcome this barrier of fertilization failure, some investigators have suggested intracytoplasmic sperm injection (ICSI) on day 1 of an unfertilized mature oocyte, the so called "rescue ICSI". We report a case of fertilization failure followed by rescue ICSI resulting in a live birth. Although the success of rescue ICSI is still questionable, this procedure is worth an attempt in order to give the best chance to the couple in that cycle.

Retinal vascular occlusion is the most common cause of retinopathy leading to severe visual loss in all age groups. Central retinal vein occlusion (CRVO) is usually seen in older age group and is often associated with systemic vascular diseases. Although the exact cause and effect relationship has not been proven, central retinal vein occlusion has been associated with various systemic pathological conditions, hence a direct review of systems toward the various systemic and local factors predisposing the central retinal vein occlusion is advocated. We describe the development of central retinal venous occlusion with associated cystoid macular edema (CME) in two healthy infertile women who were recruited for in vitro fertilization cycle for infertility. Predisposing risk factors associated with central retinal vein occlusion are obesity, sedentary life style, smoking, and some systemic diseases such as hyperlipidemia, hypertension, associated autoimmune disorders e.g., antiphospholipid antibody syndrome, lupus, diabetes mellitus, cardiovascular disorders, bleeding or clotting disorders, vasculitis, closed-head trauma, alcohol consumption, primary open-angle glaucoma or angle-closure glaucoma.In our patients, they were ruled out afterdoing allpertaining investigations. The cases were managed with further avoidance of oral contraceptives and intra-vitreal injections of Bevacizumab (Avastin), an anti-vascular endothelial growth factor (anti-VEGF drug) and Triamcinolone acetonide (a long acting synthetic steroid). Hence, even if no systemic diseases are detected. Physical examinations are recommended periodically for young women on oral contraceptive pills.

Severe ovarian hyperstimulation syndrome remains one of the life threatening complication of assisted reproductive technology. In refractory cases of late ovarian hyperstimulation syndrome (OHSS), clinicians are left with limited therapeutic options. We report a case of refractory OHSS which was managed successfully using thawed plasma. Thawed plasma transfusion could be potential therapeutic option for managing patients with severe ovarian hyperstimulation not responding to conventional treatment.