Journal of Human Reproductive Science
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    Table of Contents - Current issue
April-June 2018
Volume 11 | Issue 2
Page Nos. 83-207

Online since Wednesday, August 1, 2018

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From the editors desk p. 83
Madhuri Patil
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Fertility treatment in couples with seropositivity for human immunodeficiency virus: Ethics opinion p. 86
Duru Shah, Madhuri Patil
Human immunodeficiency virus results in acquired immunodeficiency syndrome which alters the immune system. The virus can be transmitted through contact with infected semen, vaginal fluids, or blood.
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Upper age limit for assisted reproductive technologies: Ethics opinion p. 89
Sujata Kar, Duru Shah, Madhuri Patil
Fertility in women is closely related to reproductive age and becomes significantly compromised before the onset of perimenopausal menstrual irregularity. There is decrease in oocyte quality with age which is reflected by the increase of chromosomal aberrations in the oocytes and embryos. Oocyte or embryo donation to women of advanced age should be discouraged.
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Provision of fertility services for women at increased risk of complications: Ethics opinion p. 91
Nalini Mahajan, Duru Shah, Madhuri Patil
Certain medical conditions can increase the risk to the mother during pregnancy. This can increase the risk of maternal morbidity or severe morbidity. If pregnancy is decided upon after expert counseling, a multidisciplinary team should provide care.
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Maximum number of embryos to be transferred in assisted reproductive technologies cycle: Ethics opinion p. 93
Madhuri Patil, Duru Shah
Prevention of multiple pregnancies is of utmost importance as with multiple pregnancy-assisted reproductive technologies results shifts from success to complications. There is an increase in the maternal and neonatal morbidity and mortality with occurrence of higher order pregnancies. Therefore, restricting the number of embryos transferred either to one or two would reduce the occurrence of multiple pregnancy.
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Consensus statement on the use of oral contraceptive pills in polycystic ovarian syndrome women in India p. 96
Duru Shah, Madhuri Patil, On behalf of the National PCOS Working Group
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Urinary versus recombinant gonadotropins for ovarian stimulation in women undergoing treatment with assisted reproductive technology p. 119
Ameet Patki, Himanshu Bavishi, Chandravati Kumari, Jayarani Kamraj, M Venugopal, KU Kunjimoideen, Poornima Nadkarni, Samundi Sankari, Sunil Chaudhary, MJ Sangeeta, CS Manjunath, Pratap Kumar
Globally, about 10%–15% couples are affected by infertility, with major role being played by the couple's lifestyle. Several gonadotropin preparations (urinary, purified urinary, recombinant, and biosimilars) are available for use. Purified urinary formulations offer numerous advantages over their predecessor, including lesser injection dose required, ability to be administered subcutaneously, less batch-to-batch variability, better efficacy, ability to individualize protocols as per patient's need, better control of developing follicles, less risk of multiple pregnancies, and hyperstimulation. Published results of Cochrane reviews and meta-analysis show no difference in efficacy or safety between urinary and recombinant gonadotropins. In the absence of any significant difference, cost plays an important role in deciding choice of gonadotropins. In this article, we have reviewed the results of comparative clinical trials, Cochrane analysis, and meta-analysis to derive consensus statements regarding efficacy, safety, and cost implications of urinary versus recombinant gonadotropin preparations.
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Role of autologous bone marrow-derived stem cell therapy for follicular recruitment in premature ovarian insufficiency: Review of literature and a case report of world's first baby with ovarian autologous stem cell therapy in a perimenopausal woman of age 45 year p. 125
Shreya Gupta, Pooja Lodha, M Selva Karthick, Sunita Rajesh Tandulwadkar
Stem cell (SC) therapy has come up enormously, particularly for indications where not much can be done medically or surgically to improve the condition. SCs are the foundation cells for every organ, tissue, and cell in the body, and it can either reproduce into a SC or differentiate into specialized types of cells. Premature ovarian insufficiency (POI) is a clinical syndrome defined by loss of ovarian activity before the age of 40 years. POI is characterized by menstrual disturbance (amenorrhea or oligomenorrhea) with raised gonadotropins, low anti-Mullerian hormone (AMH), and estradiol level. Autologous SCs were tried in POI to increase the follicular recruitment and avoiding the need for oocyte donation program. This review analyzes the causes, etiopathogenesis, and role of autologous bone marrow-derived SC therapy (ABMDSCT) in POI. It also highlights the recent studies and summarizes the current understanding and future directions for SCs in POI. Here, we also report the first successful birth of a baby from India, where autologous SC therapy in a 45-year-old perimenopausal single woman helped in procuring a pregnancy and delivery of a healthy 2.7 kg female baby through assisted reproduction. In the absence of SC therapy, accepting oocyte donor program or adoption would have been the only viable options for this patient for which she was not ready. This may be the world's first successful case of application of ABMDSCT in a 45-year-old female to give successful birth to a healthy baby.
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Women diagnosed with endometriosis show high serum levels of diethyl hexyl phthalate p. 131
Sadia Nazir, Zeenat Usman, Muneer Imran, Khalid Pervaiz Lone, Gulfam Ahmad
Background: Endometriosis is one of the common causes of infertility with very diverse etiology. In modern lifestyle, humans are exposed to several endocrine-disrupting chemicals (EDCs) which may lead to reproductive disturbances. Diethyl hexyl phthalate (DEHP) is one of the common EDCs to which women are exposed by the use of cosmetics, perfumes, food packaging, medicine, and insecticides. Aim: The aim of this study was to measure the levels of DEHP in women diagnosed with endometriosis and healthy females and to compare these levels among different stages of endometriosis. Setting and Design: This descriptive study was conducted at a tertiary care hospital. Subjects and Methods: This study comprised of fifty women diagnosed with endometriosis, aged 20–40 years, and fifty age-matched healthy, fertile women without endometriosis. Females on any medication/comorbid conditions were excluded from the study. Serum DEHP concentrations were measured by high-performance liquid chromatography (HPLC). The results were expressed as means ± standard deviation (SD) (ng/ml of DEHP). Statistical Analysis: Data were analyzed using IBM-SPSS version 20. Two-sample Student's t-test and one-way ANOVA were applied for the analysis. Results: The mean ± SD value of DEHP in cases was 65.29 ± 21.69 ng/ml; however, the mean ± SD value of DEHP in controls was undetectable. Comparison of DEHP among stages of endometriosis revealed an increasing trend with advanced stages (III and IV). The values were not different between the two age groups of women with endometriosis (20–30 and 31–40 years). Conclusion: High levels of DEHP in women diagnosed with endometriosis suggest a role of phthalates in the etiology of endometriosis and permit careful use of such compounds.
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Screening of polymorphisms of transcription factor 7-like 2 gene in polycystic ovary syndrome using polymerase chain reaction-restriction fragment length polymorphism analysis p. 137
Yogamaya D Prabhu, Nishu Sekar, VG Abilash
Background: Polycystic ovary syndrome (PCOS) is a common endocrine disorder occurring in premenopausal women, with a prevalence rate of 5%–7%. It has been observed in multiple number of studies the coexistence between diabetes mellitus 2 and obesity with this endocrinopathic disorder. Transcription factor 7-like 2 (TCF7L2) gene is shown to be associated with insulin secretion. Aim: To screen whether the gene variant of TCF7L2 (formerly TCF4) gene is significantly associated and has susceptibilities with type 2 diabetes in PCOS. This study is essential to uncover diabetogenic association of the TCF7L2 gene variants with PCOS. Design: This was a hospital-based study. Methods: In this work, blood samples from 43 PCOS patients with age and sex similar to 43 control samples were collected, followed by isolation of DNA. Further genotyping of the TCF7L2 gene was carried out by performing polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP). Statistical Analysis: Genotype frequencies of the TCF7L2 rs7903146 gene were checked by Hardy–Weinberg equilibrium of genotype in both PCOS and the control group, and also, the frequencies of the genotype were performed accordingly. Results: There was no significant allelic variation observed among the patient and the control samples. From the patient details, it was observed that women between the age group of 21 and 25 years are susceptible to PCOS. Conclusion: From the PCR-RFLP analysis, it can be stated that there are no expected gene polymorphisms seen in this study, unlike the study carried out on the Chinese population where they observed genotype variations CC, CT, and TT. From this study, we can conclude that TCF7L2 rs7903146 gene cannot be considered as the candidate gene for the occurrence of PCOS.
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Methylenetetrahydrofolate reductase gene-specific methylation and recurrent miscarriages: A Case- Control Study from North India p. 142
Kallur Nava Saraswathy, Lovejeet Kaur, Seerat Talwar, Jyoti Mishra, Suraj Huidrom, MP Sachdeva, Manju Puri
Aim: This study aimed to understand the association of gene-specific methylation of the promoter region of methylenetetrahydrofolate reductase (MTHFR) in the causation of recurrent miscarriages (RMs) both independently and also in light of MTHFR C677T polymorphism, hyperhomocysteinemia, folate, and Vitamin B12 deficiency. Settings and Design: This was a hospital-based, case–control, observational study. Methods: The proposed study included a total of 85 RM cases and 121 nonpregnant controls. Biochemical (homocysteine, folate, and Vitamin B12) investigations, MTHFR polymorphism (C677T), and MTHFR allele-specific methylation were done on all the samples. Results: Methylation-specific polymerase chain reaction of MTHFR gene revealed that methylated allele (single dose) was found to pose a significant 3.6-fold increased risk for RM. The degree of risk of methylated allele for RM was found to be aggravated from the normal genotype CC (2.8 folds) to CT (7.5 folds) individuals. Vitamin B12 deficiency and folate repletion were found to be posing an increased risk in association with methylated allele for recurrent miscarriages as compared to the respective controls. Conclusion: Recurrent miscarriage cases were found to be hypermethylated with respect to MTHFR gene-specific methylation as compared to the controls. High prevalence of folate repletion causing imbalance between folate and Vitamin 12 levels may lead to hypermethylation among recurrent miscarriage cases. The present study highlights the significance of the epigenetic mechanisms in the causation of the recurrent miscarriages.
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Comparison of two regimens of gonadotropin-releasing hormone antagonists in clomiphene-gonadotropin induced controlled ovulation and intrauterine insemination cycles: Randomized controlled study p. 148
Sajja Devendra Siva Karthik, Alka Kriplani, Garima Kachhawa, Rajesh Khadgawat, Nutan Aggarwal, Neerja Bhatla
Context: Gonadotropin-releasing hormone (GnRH) antagonists in fixed or flexible regimens are used for prevention of premature luteinizing hormone (LH) surge, however, data comparing these regimens in stimulated intrauterine insemination (IUI) cycles are lacking. Aims: The aim of this study is to evaluate the effectiveness of GnRH antagonists in fixed and flexible regimens on the rate of premature luteinization (PL) and ovulation rate in sequential clomiphene-gonadotropin controlled ovulation–IUI cycles. Settings and Design: This study was conducted at tertiary care center; this was randomized controlled study. Materials and Methods: A total of 45 infertile women randomized into three groups of 15 each received clomiphene citrate + human menopausal gonadotrophin. GnRH antagonist was added according to fixed (n = 15) and flexible (n = 15) protocol. No antagonist in control group (n = 15). PL was defined as LH level ≥10 mIU/ml and progesterone level ≥1.0 ng/ml. Statistical Analysis: Mean values compared using the Student's t-test or one-way analysis of variance. Categorical variables distribution tested using either Pearson's Chi-square or Fisher's exact test as appropriate. Results: Of a total of 45 women, 58% (n = 26) presented with primary and 42% (n = 19) secondary infertility with mean age of 30.8 ± 3.43 years and BMI 26.57 ± 3.22 kg/m2. Fixed regimen (3.7%) showed most reduction in PL compared to flexible (15.38%, P = 0.33) or control (36.67%, P = 0.004). On human chorionic gonadotropin day, mean LH (P = 0.002) and progesterone (P = 0.079) levels in fixed, flexible, and control groups were as follows: 5.04 ± 5.47 mIU/ml, 3.95 ± 4.16 mIU/ml, 9.57 ± 7.91 mIU/ml, and 0.409 ± 0.320 ng/ml, 0.579 ± 0.727 ng/ml, and 1.033 ± 1.022 ng/ml, respectively. Ovulation (P = 0.813) and pregnancy rates (P = 0.99) were 88.9%, 84.6%, and 90% and 22.2%, 19.23%, and 10% in fixed, flexible, and control groups, respectively. Conclusions: Addition of antagonist in any regimen appears to lower PL rates and improve pregnancy rates in controlled ovarian stimulation and IUI cycles.
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A prospective case–control trial to evaluate and compare the efficacy and safety of atosiban versus placebo in In vitro Fertilization-embryo transfer program p. 155
Vineet Mishra, Himani Agarwal, Sugandha Goel, Priyankur Roy, Sumesh Choudhary, Sunita Lamba
Background: Recent developments in assisted reproductive technology focus on potential advances to improve its success rate. Atosiban, a combined oxytocin/vasopressin V1a receptor antagonist, is a novel class of drug involved in basic priming of the uterus for successful implantation during embryo transfer (ET). Objectives: The objective of this study is to evaluate the efficacy of atosiban (study group) in ET patients in comparison to placebo (control group) regarding implantation rate (IR), clinical pregnancy rate (CPR), and ongoing pregnancy rate and to assess the safety profile of atosiban. Materials and Methods: A total of 320 women undergoing in vitro fertilization-ET at a tertiary care hospital were enrolled in the study. In the study group, atosiban was given as initial intravenous (IV) bolus injection 0.9 ml (6.75 mg), 30 min before ET followed by continuous IV infusion of atosiban. In the control group, placebo (normal saline) was infused at the same rate and dose. Pregnancy was confirmed 14 days after ET by β-human chronic gonadotropin level. IR and CPR were determined by doing transvaginal sonography 3 weeks and 6 weeks postET, respectively. Results: In women with atosiban treatment, the positive pregnancy rate and CPRs were 41.25% and 36.25%, respectively. The IR per embryo transferred was 17.5%. No major side effects of atosiban were noted among enlisted patients. The miscarriage rate and ectopic pregnancy rate were low (12.12% and 4.54%, respectively). Forty-two women had singleton gestation, while twin and triplet pregnancies were encountered in 13 and 3 women, respectively. No congenital anomalies were observed during an antenatal scan at 18–20 weeks in ongoing pregnancies. The positive pregnancy rate, the CPR, and the IR in the control group was 35%, 30%, and 16.5%, respectively, which was significantly lower than the atosiban group. Conclusion: Atosiban reduces uterine contractions and increases endomyometrial perfusion, both of which have potential benefits regarding improved IRs, CPR, and ongoing pregnancy rates. Atosiban has a good embryonic safety profile.
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One plus one is better than two: Cumulative reproductive outcomes are better after two elective single blastocyst embryo transfers compared to one double blastocyst embryo transfer p. 161
Vidhisha P Mehta, Jayesh A Patel, Reena H Gupta, Sandeep I Shah, Manish R Banker
Aims: The aim of this study is to compare cumulative in vitro fertilization-intracytoplasmic sperm injection outcomes following two elective single embryo transfer (eSET) versus one double embryo transfer (DET) using blastocyst(s). Settings and Design: This was retrospective observational study. Study Period: The study was conducted during January 2015–December 2015. Subjects and Methods: Forty-one fresh + 25 frozen eSET versus 123 DET using self-oocytes and 68 fresh + 35 frozen eSET versus 184 DET using donor-oocytes were included in the study. All failing to achieve live birth after first eSET underwent frozen embryo transfer cycle with second blastocyst. Cumulative outcome after two eSET were compared with one DET. Statistical Analysis Used: The analysis was performed by Chi-square and t-test. Results: In self-oocytes group, higher but statistically nonsignificant cumulative clinical pregnancy rate (CPR) (58.5% vs. 57.7%, P = 0.92) and live birth rate (LBR) (48.7% vs. 44.7%, P = 0.65) with significantly lower multiple pregnancy rate (MPR) (4.2% vs. 45%, P = 0.0002) were obtained; whereas in donor-oocytes group, comparable cumulative CPR (73.5% vs. 65.7%, P = 0.24), significantly higher LBR (64.7% vs. 48.9%, P = 0.02) and significantly lower MPR (4% vs. 51.2%, P = 0.00005) were obtained after two eSET vs. one DET. In self-oocytes group, the incidence of prematurity (10% vs. 21.4%, P > 0.05) and low birth weight (25% vs. 45.6%, P > 0.05) were lower but statistically nonsignificant, whereas in donor-oocytes group, incidence of prematurity was lower but statistically nonsignificant (26.7% vs. 38.8%, P > 0.05) while of low birth weight was significantly lower (32.7% vs. 51.2%, P = 0.0038) after two eSET versus one DET. Conclusion: Cumulative LBR was higher with lower incidence of multiple births, prematurity and low birth weight after two eSET versus one DET using self- or donor-oocytes. Higher use of eSET improves reproductive outcomes in patients with good prognosis.
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Acceptance of donor eggs, donor sperms, or donor embryos in Indian infertile couples p. 169
Kaberi Banerjee, Bhavana Singla
Context: The reduction or loss of natural fertility is deeply painful in couples that are considering the use of donor gametes or donor embryos. This is the first study to assess the acceptability of donor gametes or embryos in Indian population. Aim: The aim of the study was to assess the attitude toward egg, sperm, and embryo donation among Indian the infertile couples. Settings: This study was conducted at infertility outpatient clinic New Delhi. Design: This study was a cross-sectional study. Materials and Methods: From October 1, 2015, to December 31, 2015, a total of 594 infertile couples were assessed. A well-structured questionnaire was given to each infertile couple at the first visit. Both female and male partners had filled the questionnaire separately. The acceptance rate of couple toward the egg, sperm, and embryo donation was assessed. Results: Out of 594 female partners, 118 females agreed for donor eggs (19.9%), 116 females agreed for donor sperms (19.5%), and 93 females agreed for donor embryos (15.7%). Out of 594 male partners, 262 males agreed for donor eggs (44.1%), 90 males agreed for donor sperms (15.2%), and 141 males agreed for donor embryos (23.7%). Conclusions: The overall acceptance of donor eggs, sperms, or embryos in Indian infertile couples is low. The acceptance rate of females for donor eggs or donor sperms is same, but males are more amenable to accept donor eggs than donor sperms. This is the first study to assess the acceptability of donor gametes or embryos in Indian population.
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Sociocultural determinants of infertility stress in patients undergoing fertility treatments p. 172
Ansha Patel, P S V N Sharma, Pratap Kumar, VS Binu
Introduction: Involuntary childlessness is a distressing condition that has considerable social implications in developing nations. Aim: The present study aims to investigate the less known sociocultural determinants of infertility stress in patients undergoing assisted conception and reproductive treatments. Methods: This cross-sectional research was conducted on 300 men and women with primary infertility. The profile of sociodemographic variables, clinical variables, and sociocultural variables was collected using a locally devised questionnaire. Infertility stress was assessed using the psychological evaluation test. Statistical Analysis: Research data were analyzed using SPSS 15. Chi-square test is used for univariate analysis. Multiple logistic regression with enter method is used to examine the association between infertility stress and sociocultural variables. Results: The findings suggest that in both men and women, low spousal support, financial constraints, and social coercion in early years of marriage predicts infertility distress. Peer-support neither predicts nor protects against distress. Discussion: Family acceptance and social security for infertility is low. Stigma, concealment, and discrimination among men are reported to be high. Distress is three times greater in women with overinvolved family members who had unrealistic expectations from treatments. Taking continuous cycles of fertility treatments seems unaffordable for most patients. Subfertile individuals were socially perceived to be deprived, blemished, incomplete, and sexually incompetent. Conclusion: Data from this investigation, provides a glimpse into sociocultural aspects of infertility. The findings may be useful for identifying targets for individual and family-focused psychological interventions for distress reduction in infertility.
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Illness cognitions, anxiety, and depression in men and women undergoing fertility treatments: A dyadic approach p. 180
Ansha Patel, P S V N Sharma, Pratap Kumar, VS Binu
Background: Emotional response to infertility is mediated by numerous interrelated psychological variables such as personality, health perceptions, cognitive appraisals, coping, and social support. While men and women respond to infertility differently, illness cognitions are a vital component of their emotional adjustment. The aim of this study is to compare the infertile men and women undergoing fertility treatments on perceived distress, helplessness, acceptance, benefits, anxiety, and depression. Materials and Methods: Eighty-one infertile couples, undergoing intrauterine insemination participated in the study. They were assessed on the presence of infertility distress using the fertility problem inventory, for psychiatric morbidity using the Mini International Neuropsychiatric Interview, for affective disturbances using the Hamilton Anxiety and Depression scales, and for illness cognitions using the Illness Cognition Questionnaire. Statistical Analysis: Data are analyzed using SPSS version 15. The paired sample t-test is performed for assessing differences on normally distributed data. The Wilcoxon Signed-Rank test is performed for assessing differences in medians obtained on data that was skewed. Results and Discussion: Infertile women (wives) were more emotionally distressed, anxious, and depressed than men (husbands). Gender-wise differences were found for perceptions of helplessness and acceptance of infertility. Infertility was perceived to be a nonbeneficial event for both partners investigated. Conclusion: Negative cognitions and affective disturbances may contribute to higher treatment burden in couples seeking-assisted conception. The present study suggests that psychosocial intervention for couples plays a central role and should be integrated within the conventional treatments for infertility.
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Adult granulosa cell tumor: A sinister differential for clomiphene-resistant infertility p. 190
Shalini Gainder, Japleen Kaur, Sujata Siwatch, Nalini Gupta
Granulosa cell tumors (GCTs) are rare sex cord–stromal tumors of the ovary. They may present with features of hyperestrogenism. We present a case of a 29-year-old nulliparous female, with infertility and oligomenorrhoea, initially managed with a provisional diagnosis of polycystic ovarian syndrome. She did not respond to multiple cycles of ovulation induction with clomiphene citrate. Later, an ovarian mass was detected, and she was initially planned for laparoscopy. Magnetic resonance imaging pelvis revealed a solid-looking mass in the ovary, with increased vascularity. Fine-needle aspiration cytology from the mass suggested GCT. She underwent staging laparotomy with fertility-preserving surgery. Thereafter, she conceived on first cycle of clomiphene citrate. She delivered twins and is presently 8 months postpartum. Thus, a high index of suspicion for underlying androgen- or estrogen-secreting tumor in cases of clomiphene-resistant infertility with ovarian cysts is advisable.
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Assisted reproductive techniques in a patient with history of venous thromboembolism: A case report and review of literature p. 193
Sumana Gurunath, Sriprada Vinekar, Reeta Biliangady
We report a patient with a history of venous thrombosis following oral contraceptive pills who was planned for in vitro fertilization (IVF)-intracytoplasmic sperm injection for male factor infertility. This article discusses the mechanisms for predisposition to thrombosis during assisted reproduction in patients at high risk. Assessment of risk before commencement of treatment, use of mild stimulation, antagonist protocol, avoiding ovarian hyperstimulation, use of gonadotropin-releasing hormone agonist trigger and avoiding exposure to human chorionic gonadotropin, frozen embryo transfer in a natural cycle, single embryo transfer, avoiding multiple pregnancy, and use of prophylactic or therapeutic anticoagulation are the various risk-reduction strategies that must be adopted during IVF treatment to reduce the risk of thrombosis to that of natural conception.
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Pregnancy through assisted reproductive technology in a patient with thoracic endometriosis syndrome p. 198
S Krishnakumar, Rohan Krishnakumar, Sonali Hiwale
Extrapelvic endometriosis is known to be difficult to diagnose. Appropriate management in an infertile patient with extrapelvic endometriosis is not only difficult but also not well established. This case report describes a patient with thoracic endometriosis syndrome who was managed successfully for controlling her pleural endometriosis and achieving a pregnancy through assisted reproductive technology (ART).
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Outcomes of structured psychotherapy for emotional adjustment in a childless couple diagnosed with recurrent pregnancy loss: A unique investigation p. 202
Ansha Patel, N Dinesh, P S V N Sharma, Pratap Kumar, VS Binu
Losing a much-awaited pregnancy and an unborn child, time and again is known to be a painful experience in recurrent miscarriage or pregnancy loss (RPL). Literature on psychological consequences of RPL is abundant. Nonetheless, application of psychological intervention in RPL remains to be an overlooked area. Using a repeated measures design and standardized psychological measures, this case study assessed the outcomes of mindfulness-based therapy administered with routine fertility treatment in a couple with the history of recurrent miscarriages and secondary infertility. Data analysis was done using clinically significant change and analysis of graphic trends. Psychotherapy helped the couple initiate a meaningful discourse with the stress following miscarriage, uncertainty of pregnancy, and fertility-related emotional struggles by mindfully transforming stressors into less painful experiences. Control studies on applications of such therapies are needed to provide definitive answers to “what works, for whom, when, and how,” with distressed patients experiencing RPL.
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