scholarly journals Comparative evaluation of different cost effective ovulation induction drugs and their effect on follicular growth, endometrial thickness and pregnancy outcome

Author(s):  
Madhumithaa Narayanan ◽  
Uruj Jahaan ◽  
Neena Gupta

Background: Ovulatory dysfunction is a common cause of female infertility, occurring in up to 20 - 30% of infertile women. The most commonly prescribed ovulation drugs are clomiphene citrate (CC), tamoxifen, aromatase inhibitors (such as letrozole) and gonadotropins. Objective of the study was to evaluate the efficacy of clomiphene citrate, letrozole and tamoxifen for ovulation induction in anovulatory infertility.Methods: Randomized open label interventional clinical trial. Patients were randomized to 3 drug groups. After baseline investigations, they were subjected to ovulation induction and then USG monitoring of follicular growth and ovulation. The primary outcome measured was occurrence of conception. Secondary outcome was effect on endometrial thickness and ovulation rate.Results: In the study, letrozole group showed 100% mono-follicular response. Mid cycle endometrial thickness in about 17% of cases in CC group is ≤8 mm. But all the cases in tamoxifen and letrozole group have ET >8 mm. This difference is statistically significant. The ovulation and conception rates are highest in letrozole group but the difference was not statistically significant.Conclusions: Letrozole produces higher mid cycle endometrial thickness, 100% mono follicular development than clomiphene and tamoxifen. This difference is found to be statistically significant. Ovulation rate and conception rate is highest in letrozole group. But there is no statistically significant difference among the three drugs.

Author(s):  
Monica Soni ◽  
Jeevika Gupta ◽  
Arti Meena

Background: The present study was design to compare letrozole (5 mg) and clomiphene citrate (100 mg) as first line ovulation induction drug in infertile anovulatory polycystic ovarian syndrome (PCOS) women.Methods: This prospective randomized clinical trial included 60 cases of PCOS with anovulatory infertility. The first group comprised of 30 patients who received 5 mg letrozole daily and the second group received 100 mg clomiphene citrate daily for 5 days starting on day 2-5 of menses. Both the groups were followed by ultrasound for follicle monitoring, ovulation and endometrial thickness. When dominant follicle reaches a diameter of more than or equal to 18mm and endometrial thickness ≥7.5 mm, human chorionic gonadotrophin (hCG) 5,000 IU was given intramuscularly and timed intercourse was advised. Main outcome measures were occurrence of ovulation, endometrial thickness and pregnancy rates.Results: The mean age, body mass index, and number of cases of primary and secondary infertility in both the groups showed no statistically significant difference. Multi-follicular development during induction was statistically significantly greater in the clomiphene group (1.27±1.11 versus 2.03±1.65; p=0.041). Ovulation occurred in 24 subjects (80%) in letrozole group and 18 subjects (60%) in the clomiphene group, with a statistically significant difference between the two groups (p=0.024). Pregnancy occurred in 16 subjects (53.33%) in letrozole group and 7 subjects (23.33%) in clomiphene group, which shows statistically significant difference between the two groups (p=0.048).Conclusions: Though number of developing follicles was found statistically significant with clomiphene citrate but ovulation rate and pregnancy rate were higher with letrozole group. Therefore, letrozole is a safe and better alternative for ovulation induction in patients of anovulatory PCOS, and it may be considered as a first line treatment for ovulation induction in these patients. 


QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Ahmed Mohamed Nour El-Din Hashaad ◽  
Reda Mokhtar Kamal Ghanem ◽  
Sara Abouelfath Abouelasrar Gad Dawoud

Abstract Background Polycystic ovary syndrome (PCOS) is considered one of the most common endocrine disorders affecting females in their reproductive age. In PCOS, an imbalance between androgens, anti-Müllerian hormone (AMH) and follicle stimulating hormone (FSH), cause a halt of follicular growth. Insulin resistance (IR) is another important component of PCOS. There is increasing evidence that vitamin D affects insulin and glucose metabolism, Vitamin D plays a vital role in the regulation of glucose-insulin homeostasis. Objectives to assess the efficacy of vitamin D supplementation in improving ovulation induction in PCOS women (1ry outcome) and increasing pregnancy rate (secondary outcome). Patients and Methods 120 women diagnosed PCOS according to Rotterdam criteria and were resistant to CC treatment were randomly allocated into equal two groups: Group V: number of 60 patients received cholecalciferol + Metformin for 2 months. Group C: 60 patients received Metformin 2 months. After two months from the start:Both study groups started induction with Clomiphene Citrate added every month starting from the 3rd month to the 5th month (3 cycles of ovulation induction) in addition to previous drugs mentioned. Results In our study results, regulation of menstrual cycle occured in 63.6% of women who recieved vitamin D + metformin (group V) and ovulation was confirmed in 34.5% of the total number (55 women). Later, 18% of them got pregnant after 3 months of treatment. Added to that 16 women out of 39 (41%) got pregnant by the end of the follow up period with cumulative pregnancy rate (53%). On the other hand menstrual regularity in (group C: metformin) recorded 61% with ovulation percentage of 26.9% (n = 54). Followed by 14.8% pregnancy rate at the 3rd month., which increased to 27.5% by the end of the study out of 47.5% ovulated women (n = 40). Cumulative pregnancy rate 40%. Conclusion From the current study we can conclude that there is no significant difference of adding vitamin D to CC resistant PCOS regarding ovulation and pregnancy rates. However, it can augment metformin action and improves its outcome.


2010 ◽  
Vol 2 (2) ◽  
pp. 169-173
Author(s):  
Randhir Puri ◽  
Ahmed Badawy ◽  
Ibrahim Abdel Aal ◽  
Mohamed Abulatta

Objective To compare the effects of letrozole (5 mg) and clomiphene citrate (100 mg) for ovulation induction in women with polycystic ovary syndrome (PCOS). Design Prospective randomized trial. Setting University teaching hospital and private practice setting. Patients The study comprised a total of 438 infertile women (1063 cycles) with PCOS. Intervention Patients were randomized to treatment with 5 mg of letrozole daily (218 patients, 545 cycles) or 100 mg of clomiphene citrate daily (220 patients, 518 cycles) for 5 days starting on day 3 of menses. Timed intercourse was advised 24 to 36 hours after hCG injection. Main Outcome Measure Number of follicles, serum estradiol, serum progesterone, endometrial thickness, and pregnancy and miscarriage rates. Results The mean age, parity, and duration of infertility in both groups were similar. The total number of follicles was statistically significantly greater in the clomiphene citrate group (6.8 _ 0.3 vs 4.4 _ 0.4). Endometrial thickness at the time of hCG administration was statistically significantly greater in the CC group (9.2 _ 0.7 mm vs 8.1 _ 0.2 mm). The duration to reach a dominant follicle was statistically significantly longer in the letrozole group (12.1_1.3 vs 8.8_2.9 days). Ovulation occurred in 365 out of 540 cycles (67.5%) in letrozole group and 371 out of 523 cycles (70.9%) without a statistically significant difference. Levels of serum estradiol and progesterone were statistically significantly higher in the clomiphene citrate group. The pregnancy rate per cycle was 15.1% in the letrozole group and 17.9% in the clomiphene citrate group without statistically difference between the groups. Conclusion The results of this study did not show any advantage to the use of letrozole over clomiphene citrate as a first-line treatment for induction of ovulation in women with PCOS (Fertil Steril_2009;92:849-52. _2009 by American Society for Reproductive Medicine).


Author(s):  
Aritra Maji ◽  
Manisha V. Ramani ◽  
Kajal Kiran

Background: Anovulatory dysfunction is a commonly encountered problem which is responsible for about 40% of female infertility. One of the leading causes of female infertility is polycystic ovarian syndrome (PCOS). Clomiphene citrate has been the drug of choice in treating women with anovulatory infertility. However, in recent years, letrozole, an aromatase inhibitor, has emerged as alternative ovulation induction agent. Aim of this study was to compare efficacy of clomiphene citrate and letrozole as first line therapy for ovulation induction in polycystic ovarian syndrome.Methods: This study was a hospital based prospective comparative study done in MVJ MC and RH involving 100 females suffering from infertility due to anovulation. They were divided into 2 groups of 50 each. One group was given clomiphene citrate 50 mg while another group was given letrozole 2.5 mg from day 3 to day 7 of menstrual cycle. Ultrasonographic follicular monitoring was done and injection beta HCG 5000 IU was given once follicle reached optimum size (≥18 mm) and endometrial thickness was adequate (≥7 mm). Patients were advised for timed intercourse after 24-36 hours of HCG administration. Ovulation was detected by sonographic findings of follicular rupture done after 48 hours. Primary outcomes measured were number of growing follicles (≥18 mm), endometrial thickness, ovulation rate and pregnancy rate.Results: In our study there was significant difference in the outcomes of ovulation induction between letrozole group and clomiphene group.  Women who received letrozole showed improved endometrial growth (8.44 mm versus 7.86 mm), ovulation rate (72% versus 56%) and pregnancy rate (22.2% versus 14.3%) than those who received clomiphene. However, variation in follicular growth was negligible between the two groups (1.28 versus 1.36).Conclusions: Letrozole is a superior alternative to clomiphene citrate for ovulation induction in cases of PCOS with anovulatory menstrual cycle, and can be considered as first-line therapy for ovulation induction in such women.


Author(s):  
S. R. Gayathri ◽  
Saswati Tripathy ◽  
M. Muthulakshmi

Background: Hypothalamic pituitary axis dysfunction accounts for majority of ovulatory disorders and a predominant cause of women with PCOS. There is a dopaminergic control on gonadotropin secretion. In normoprolactinemic PCOS patients transient rise in serum prolactin can be observed during the late follicular phase and luteal phase. So, the aim of the study is to know the effect of bromocriptine and clomiphene in ovulation induction as compared to clomiphene alone.Methods: Based on the various inclusion and exclusion criteria, seventy patients were randomly assigned into two groups. The patients in the first group were treated with tablet of clomiphene citrate (100 mg) from day 3 to day 7 of each cycle. The patients in the other group received 100mg of clomiphene citrate from day 3 to day 7 of each cycle and tablet bromocriptine (2.5 mg) from day5 to day14. Both groups were followed up with follicular study for three months. At the end of the three cycles the hormonal statuses of the patients were determined.Results: There was no significant difference found in other hormones like serum FSH, LH and estradiol in both groups. The follicular diameter and the average endometrial thickness was increased to a significant level in the CC+Bcrt group as compared to the CC group. The rate of ovulation and pregnancy rate was higher in combination group.Conclusions: Bromocriptine with clomiphene in follicular phase has an advantage of improving follicular diameter, endometrial thickness and hence ovulation and pregnancy rates. 


2022 ◽  
Author(s):  
Pattraporn Chera-aree ◽  
Sirikul Tanpong ◽  
Isarin Thanaboonyawat ◽  
Pitak Laokirkkiat

Abstract Objective To compare the efficacy of combination clomiphene citrate (CC) plus letrozole with that of CC alone for ovulation induction in infertile women with chronic anovulation. Material and methods This randomized controlled trial was conducted at the Infertility and Reproductive Biology Unit of the Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand during the August 2020-September 2021 study period. Anovulatory women aged 18-40 years were equally allocated into either the CC 50 mg plus letrozole 2.5 mg once daily group or the CC 50 mg once daily group. The study drugs were administered on days 3-7 of each study patient’s menstrual cycle. The primary outcome was the ovulation rate defined by serum progesterone >3 ng/mL at mid-luteal phase. The secondary outcomes were menstrual cycle characteristics, endometrial thickness, conception rate, and adverse events. Results One hundred women (50 per group) were enrolled. The mean age and prevalence of polycystic ovary syndrome were non-significantly different between groups. The ovulation rate according to intention-to-treat analysis was 78% and 70% in the combination and CC alone groups, respectively (p>0.05). There was no significant difference between groups for either mean endometrial thickness or number of dominant follicles. No serious adverse events were observed in either group. Conclusion There was no significant difference between combination CC plus letrozole and CC alone relative to their ability to induce ovulation in infertile women with chronic anovulation. The small number of live births (1 per group) was too low to be statistically analyzed.


2021 ◽  
Vol 10 (27) ◽  
pp. 1991-1995
Author(s):  
Jawahira Chishti ◽  
Jai Chowdhary ◽  
Archana Paliwal ◽  
Chetan Kumar Sharma ◽  
Manisha Choudhary

BACKGROUND Superovulation with intrauterine insemination (IUI) increases the probability of pregnancy by increasing number of oocytes and sperm density. The main oral agents used for superovulation are clomiphene citrate and letrozole. Clomiphene citrate a selective estrogen receptor modulator with predominant antiestrogenic action has adverse effects on endometrium and cervical mucous. Letrozole an aromatase inhibitor acts by reducing estrogen production by blocking androgen conversion to estrogen in ovary and peripheral tissues without affecting endometrium and cervical mucous. We wanted to compare the efficacy of letrozole v/s clomiphene citrate as first line ovulation induction drug in infertile patients undergoing IUI. METHODS Based on the inclusion and exclusion criteria, we included 160 patients in our study. They were divided into two groups of 80 each based on the drug given for ovulation induction. The drug was given for 5 days from D3 to D7 of menstrual cycle. IUI was done 38 - 40 hours after trigger and after confirmation of ovulation by sonography. RESULTS The mean age, body mass index (BMI), duration of infertility, type and cause of infertility in both groups were similar. Ovulation rate was 85 % in letrozole group and 71.25 % in clomiphene citrate group, which was statistically significant (P0.035). There was no statistically significant difference between endometrial thickness and total days till ovulation between two groups. Monofolliculogenesis and clinical pregnancy rate were statistically significantly higher in letrozole group. CONCLUSIONS Our study shows that letrozole has better pregnancy rate in comparison to clomiphene citrate (C. C.) in IUI cycles with less risk of anovulation, thin endometrium and multi follicular growth. KEY WORDS Clomiphene Citrate (C.C.), Letrozole (LTZ), Ovulation Induction (OI), Intrauterine Insemination (IUI)


Author(s):  
Rokshana Ivy ◽  
Afroza Chowdhury ◽  
Kulsum Haque ◽  
Hasmot Ara

The study was designed to compare the effectiveness of Letrozole and clomiphen citrate in the treatment of anovulatorv infertility. Thirty patients were selected randomly who had anovulatorv infertility. In letrozole group, fifteen patients got 5-7.5 mg of letrozole orally and in clomiphen citrate group, 100-150 mg of clomiphen citrate was given orally for maximum of six cycles and in both the groups the drugs were started from day 3 -7 of the menstrual cycle. There were no significant differences between the age, duration and type of fertility. But statistically significant increase of follicular development in letrozole group (ñ=0.020). Mean endometrial thickness was 8.33±1.54 and 5.36±1.84 respectively in letrozole and in clomiphen citrate group (ñ =0.048). There was no significant difference in ovulation in both the groups but pregnancy was more (33.3%) with the letrozole group. Letrozole is an effective agent for ovulation induction. It can be used as an alternative to CC as a first-line of treatment for ovulation induction. DOI: 10.3329/bjpp.v25i1.5739Bangladesh J Physiol Pharmacol 2009; 25(1&2) : 10-12


Author(s):  
Nehad Maher Motit ◽  
Ayman Abdelaziz El-Dorf ◽  
Shahinaz Hamdy Elshourbagy ◽  
Manal Mostafa Abdullah

Background: Clomiphene citrate (CC) is still the traditional therapy used for inducing ovulation in polycystic ovary syndrome (PCOS). Clomiphene resistance, which refers to persistence of anovulation after standard CC therapy, occurs in 15%–20% of patients. We aimed to compare between extended letrozole versus recombinant FSH in ovulation induction in cases of clomiphene resistant polycystic ovary Methods: Seventy women with PCOS were included then patients were equally randomized to receive one of the two drugs to be given over the next 3 months. In current study Group A: letrozole group 2.5 mg two tablets once daily for 10 days from day 2 of menses. Group B: Recombinant FSH 75 i.u s.c daily from day 2 for 5 days then monitoring dose according to folliculometry. Results: There was non-significant difference between two groups as regard FSH and LH but as regard Serum E2 (pg/mL) at day 5 of HCG administration there was significant higher in FSH recombinant group. There was insignificant difference between two groups as regard Ovulating, Number of follicles >18. There was insignificant difference between two groups as regard Size of dominant follicle, endometrial thickness at hCG (mm). OHSS, discontinuation due to OHSS, clinical pregnancy, multiple pregnancy and abortion was higher in FSH recombinant group but differences didn’t reach significance. Conclusions: There was non-significant difference between two groups in relation to ovulation, Number of follicles, Size of dominant follicle, Endometrial thickness at day of HCG injection however it was reported that OHSS, discontinuation due to OHSS, positive pregnancy test, was higher in FSH recombinant group but differences didn’t reach significance level.


Author(s):  
Lucy N John ◽  
Catherine Bjerum ◽  
Pere Millat Martinez ◽  
Rhoda Likia ◽  
Linda Silus ◽  
...  

Abstract Background Pharmacokinetic data are a pre-requisite to integrated implementation of large-scale mass drug administration (MDA) for neglected tropical diseases (NTDs). We investigated the safety and drug interactions of a combination of azithromycin (AZI) targeting yaws and trachoma, with the newly approved ivermectin, albendazole, diethylcarbamazine (IDA) regime for Lymphatic Filariasis. Methodology An open-label, randomized, 3-arm pharmacokinetic interaction study in adult volunteers was carried out in Lihir Island, Papua New Guinea. Healthy adult participants were recruited and randomized to (I) IDA alone, (II) IDA combined with AZI, (III) AZI alone. The primary outcome was lack of a clinically relevant drug interaction. The secondary outcome was the overall difference in the proportion of AEs between treatment arms. Results Thirty-seven participants, eighteen men and nineteen women, were randomized and completed the study. There were no significant drug-drug interactions between the study arms. The GMR of Cmax, AUC0–t, and AUC0–∞ for IVM, DEC, ALB-SOX, and AZI were within the range of 80–125% (GMR for AUC0–∞ for IVM, 87.9; DEC, 92.9; ALB-SOX, 100.0; and AZI, 100.1). There was no significant difference in the frequency of AEs across study arms (AZI and IDA alone arms 9/12 (75%), co-administration arm 12/13 (92%); p = 0.44). All AEs were grade 1 and self-limiting. Conclusions Co-administration of AZI with IDA did not show evidence of significant drug-interactions. There were no serious AEs in any of the study arms. Our data support further evaluation of the safety of integrated MDA for NTDs. Clinical Trials Registration. NCT03664063


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