scholarly journals Clomiphene citrate plus N-acetyl cysteine versus letrozole for induction of ovulation in infertile patients with polycystic ovarian disease: a randomized clinical trial

Author(s):  
Momen A. Kamel ◽  
Ahmed F. Amin ◽  
Tarek A. Farghaly ◽  
Nawal A. Farrag

Background: Polycystic ovarian disease (PCOD), a common endocrine disorder with multisystem affection, is the most common cause of anovulatory infertility. Our objective is to evaluate the effect of using clomiphene citrate (CC) plus N-acetyl cysteine (NAC) versus letrozole in ovulation induction in infertile patients with PCOD.Methods: Reproductive-aged infertile women either primary or secondary diagnosed as PCOD according to Rotterdam criteria, 2003 were considered for enrollment. Eligible women for were recruited and randomized (1:1) to receive either CC 100 mg plus NAC 600 mg (CC+NAC arm) or letrozole 5 mg (NCT03241472, clinicaltrials.gov). All medications were started from day 3 of the menstrual cycle for 5 days. The primary outcome was the ovulation rate in both groups. Secondary outcomes included the mid-cyclic endometrial thickness, ovarian hyperstimulation, and clinical pregnancy and miscarriage rates.Results: One hundred ten patients were enrolled and randomized to CC+NAC arm (n=55) or letrozole (n=55). The ovulation rate in patients in letrozole arm was significantly higher than CC+NAC arm (71.8% versus 53.2%, p=0.01). Additionally, endometrial thickness was higher in letrozole arm (mean±SD: 11.46±1.61 versus 9.0±1.13, p=0.031). However, no statistical significant difference with regarding the ovarian hyperstimulation rate (1.8% versus 3.6%, p=0.157), clinical pregnancy rate [3/19 patients (27.3%) versus 19/55 (34.5%), p=0.409] and miscarriage rate [4/15 patients (26.7%) versus 19/55 (15.8%), p=0.317] in CC+NAC versus letrozole groups respectively.Conclusions: Addition of NAC to CC in ovulation induction leads to comparable pregnancy rate as letrozole. However, letrozole produces high ovulation rate and the better mid-cyclic endometrial thickness.

Author(s):  
Mahija Sahu ◽  
Nihar Ranjan Rout

Background: Polycystic ovary syndrome is the commonest endocrinopathy resulting in anovulatory infertile young women. Clomifene citrate (clomiphene) is a long-standing standard drug for ovulation induction, and is still considered as first line option in PCOS women. However, clomiphene has certain disadvantage letrozole an aromatase inhibitor acts by reducing estrogen production and has no adverse effects on endometrium and cervical mucous. Indian PCOS women have high prevalence of insulin resistance and thus are likely to have high clomiphene resistance. So letrozole could prove to be a good alternative for ovulation induction in such women.Methods: This was a prospective randomized, parallel, comparative clinical trial of two ovulation induction drugs letrozole 5 mg versus clomiphene citrate 100 mg as first-line ovulation induction drug in infertile polycystic ovarian syndrome women. The target population of the study was one hundred infertile women with PCO (taking at least 2 Rotterdam’s parameters). 50 women were allocated to clomifene citrate and 50 were allocated to Letrozole for ovulation induction. Parameters like age, duration of infertility, B MI, ovulation rate, number of follicles, pregnancy rate, endometrial thickness were noted and analyzed.Results: In letrozole group, the ovulation rate, mono-follicular development, mean endometrial thickness and pregnancy rate was better in comparison to clomifene citrate group.Conclusions: The result of this study suggests that letrozole may replace clomiphene as the first line drug for ovulation induction in infertile PCOS women.


Author(s):  
Shaveta Jain ◽  
Pushpa Dahiya ◽  
Jyoti Yadav ◽  
Nitin Jain

Background: This study was conducted to evaluate the efficacy of letrozole as an ovulation inducing agent and to compare it with clomiphene citrate (CC) in infertile women.Methods: This study includes 100 women referred to gynecology OPD of Pt. B.D Sharma, PGIMS, Rohtak with   infertility due to dysovulation. The patients were divided in two groups each comprised of 50 patients, Alternate women were enrolled in study group (Letrozole). Ultrasonic follicular monitoring was done on day 10, 12, 14, 16 of menstrual cycle to measure the number, size of mature follicles. Endometrial thickness and trilaminar pattern of endometrium was compared in between the groups. Inj. Gonadotrophin (hCG) was given as a trigger intramuscularly when follicle size was between 18 to 21mm. After 36 hours of hCG administration ovulation was confirmed on ultrasound.Results: Mean age, parity, and the duration of infertility were similar in both groups. Ovulation rate was 81.6% in letrozole group and was higher than control group(p<.01). The average number of follicles in the control group was 1.90±0.77and 1.17±0.47 in the study group(p<.001). Endometrial thickness in the study group was 7.55±1.12mm and in the control group it was 6.06±0.87(p<.01). Pregnancy rate in study group was 48 % and control group 16%(p<.05).Conclusions: Aromatase inhibitors (Letrozole) is a new group of drugs to join the arsenal of infertility treatments. The result of this preliminary study suggests that letrozole is associated with higher ovulation rate, higher endometrial thickness and trilaminar pattern thus resulting in higher pregnancy rate. Clomiphene citrate may be replaced by letrozole as primary treatment for ovulation induction in infertile patients.


2021 ◽  
Vol 28 (05) ◽  
pp. 749-754
Author(s):  
Nadia Sharif ◽  
Uzma Manzoor ◽  
Saadia Bano ◽  
Uzma Shahzaad

Objective: To compare the efficacy of Letrozole and clomiphene citrate in Patients of Anovulation polycystic ovarian syndrome with Infertility. Study Design: Randomized Controlled Trial Setting: Department of Obstetrics and Gynecology Independent Medical College Faisalabad. Period: 30-09-2019 to 29-6-2020. Material & Methods: This study included 100 patients with 50 patients in each group. Group A received 2.5 to 5mg letrozole in each cycle from day 3 to 7. Group B received clomiphene citrate 50 to 100 mg incremental dose depending on ovarian response. Both Drugs were given for consecutive 3 to 6 cycles to see response. Main outcome Measure included optimal follicle size (> 18mm), endometrial thickness, and pregnancy rate. Epidemiological data and efficacy outcome measures were recorded on a Performa. Statistical analysis was done using SPSS version 13. Chi-square test applied and p-value <o.o5 was considered significant. Both group included primary infertility patients. Results: The mean age of patients was 28.03+ 3.02 years. Mean age of group A patients was 29.04+3.44 and 28.47+3.90 group B patients. Mono ovulation in group A patients (88.9%) and 27 in group b patients (60.0%). The mean endometrial thickness was 9.6mm + 1.6 in letrozole group and 6.9mm + 1.2 in clomiphene citrate group A. In group A 18% got pregnant from Letrozole group and 1.1% from the group B. Conclusion: Efficacy was significantly higher in group A Patients received letrozole as compared to patients echo received clomiphene citrate. The effects of Letrozole showed better outcome in terms of Ovulation Induction Endometrial Thickness and Pregnancy rate.


Author(s):  
Fadia J Alizzi

Objectives: The objective is to evaluate the clinical outcome of using letrozole alone or with gonadotropin as first-line ovulation induction in anovulatory infertile polycystic ovary women. Methods: A prospective single-arm study. 80 infertile polycystic ovarian syndrome (PCOS) women had been recruited between January and October 2017. Letrozole on day 2–3 of the cycle was given. The women are sorted into two groups according to the size of the dominant follicle on day 7 or 8, Group A (letrozole only group) and Group B (letrozole plus gonadotropin).Results: In our study, the overall pregnancy rate was (67.5%) and ovulation rate was 91.3%. The ovulation rate was significantly higher in Subgroup A than B (97.9% vs. 81.3%). Pregnancy rate was higher in Subgroup A (72.9% vs. 59.4%), but it was statistically not significant. The number of follicles was significantly higher in Subgroup B. Endometrial thickness, miscarriages, ovarian hyperstimulation syndrome, and multiple pregnancies were not statistically significant. Lower cycle number independently and significantly predict clinical pregnancy, while body mass index has a modest effect.Conclusions: Letrozole alone or in combination with gonadotropin as a first-line treatment in PCOS may be reasonable since this approach may improve the success rate and minimize the overall costs and risks. 


Author(s):  
Ashok Verma ◽  
Shivani Sharma ◽  
Suresh Verma ◽  
Pankaj Sharma ◽  
Tenzin Tsamo Tenga ◽  
...  

Background: To compare two protocols comprising of FSH/CC/HMG and CC/HMG for ovulation induction and IUI in women with infertility.Methods: 60 women with unexplained infertility were randomized using sequentially numbered opaque envelope method. Group A received inj FSH 150 units on day 2 of menstrual cycle and clomiphene citrate 100 mg from day 3-7, followed by injection HMG 150 units on day 9 of menstrual cycle. Group B received clomiphene citrate 100 mg from day 3-7, and HMG 150 units on day 7 and 9 of the menstrual cycle.  Ovulation triggered with hCG 5000 units when dominant follicle was 18mm. Single IUI was done 36-42 hours afterwards.Results: Pregnancy occurred in 3 out of 30 women in 116 cycles Group A (with FSH) with a pregnancy rate of 10 percent, and 2.8% per cycle. In group B (without FSH) pregnancy occurred in 3 out of 30 women in 117 cycles with pregnancy rate of 10 percent, and 2.6% per cycle. The number of follicles per cycle was 1.36 and follicle size was 18.57 mm in group A. While in Group B numbers of follicles per cycle were 1.22, with average size of 18.9mm. Mean endometrial thickness was 7.7mm in Group A and 6.37 in Group B (p=.01, significant). Mild OHSS was observed in one woman in Group B. No other side effects were observed in both the groups.Conclusions: The controlled ovarian stimulation regimes used in this study are equally effective, easy to administer, require less intensive monitoring and fewer medications, with little risk of OHSS and multiple gestation.


Author(s):  
Farahnaz Farzaneh ◽  
Fatemeh Afshar

Background: Infertility is characterized by the inability to obtain a successful pregnancy after 6 months or more with unprotected and regular intercourse. In developing countries, the incidence of infertility is 2%. The causes of infertility could be male factor or female factor, or mixed factor. Objective: This study was conducted with the aim of comparison the ovarian response to letrozole alone and letrozole plus dexamethasone in infertile women with poly cystic ovarian disease (PCOS). Materials and Methods: This randomized clinical trial was conducted on 120 infertile women with PCOS referred to Ali-Ebne-Abitaleb hospital, Zahedan, Iran from February to August 2017 into two groups: group I received letrozole alone and group II recived letrozole plus dexamethasone. The endometrial thickness, follicle diameter, and ovulation were evaluated and compared by ultrasound on days 12 to 14. Results: The mean thickness of endometrium was not different between two groups. Pregnancy rate was 8% in letrozole group and 23% in Letrozole plus Dexamethasone (p = 0.024). Also, the mean diameter of follicles in two groups were not statistically significant. Conclusion: Overall, this study showed that dexamethasone may increase pregnancy rate. Key words: Letrozole, Dexamethasone, PCOS, Induction ovulation.


2021 ◽  
Vol 15 (2) ◽  
pp. 69-73
Author(s):  
Poly Begum ◽  
Dipti Rani Shaha ◽  
Md Kamrul Hassan ◽  
Dilruba Zeba

Clomiphene citrate (CC) has been the drug of choice for the treatment of anovulatory subfertility in women with polycystic ovarian syndrome (PCOS) for a long time. Despite high ovulation rate of CC, its pregnancy rate is low. Letrozole, an aromatase inhibitor has been considered as an alternative of CC but its effectiveness is yet controversial. Our aim was to compare the efficacy and side effects of Letrozole over CC. This randomized control clinical trial was conducted in Diabetic Association Medical College and Hospital, Faridpur, Bangladesh from January 2018 to December 2019. A total of 160 women diagnosed as PCOS by Rotterdam criteria seeking treatment of subfertility were included in the study. Participants were randomly divided into two groups. Group A got Letrozole and Group B got CC as treatment. Transvaginal ultrasonogram (TVS) was performed on 12 to 13th day of the cycle to see the details of the follicles and the endometrium. The demographic information of the participants and the side effects of the drugs were recorded. Successful pregnancies were followed up for 12 weeks. Ovulation rate was almost similar among the participants of both of the groups. But monofo licular development and pregnancy rate were significantly higher among the Letrozole group (p = 0.004 and p = 0.008 respectively). Multifo licular development, multiple pregnancy, and abortion rate were significantly higher in the CC group. Patients who took Letrozole had significantly higher endometrial thickness than CC group. Both of the groups reported relatively similar incidence of side effects. Due to the higher pregnancy rate and lower incidence of abortion or multiple pregnancy, Letrozole can be an effective alternative to CC for the treatment of anovulatory subfertility of the PCOS patients. Faridpur Med. Coll. J. 2020;15(2): 69-73


Author(s):  
Disha Gupta ◽  
Asha Verma ◽  
Richa Gupta ◽  
Soniya Saini ◽  
Anuradha Salvi ◽  
...  

Background: Infertility management has become more substantial and relevant with an increase in the number of infertile patients as well as advances in the science of reproduction. The objective of our study was to assess the role of intrauterine tuboperitoneal insemination (IUTPI) and intrauterine insemination (IUI) in the treatment of infertile patients.Methods: 236 infertile patients, 118 in each group attending the infertility clinic, after applying both inclusion and exclusion criteria were enrolled in the present study. Patients in each study group were given clomiphene citrate for ovarian stimulation followed by injection hCG for triggering ovulation. Insemination with washed husband’s sperm was performed about 36-40 hours after hCG administration, using 10ml of  inseminate in IUTPI and 0.5ml inseminate in IUI. The patient was then called after 2 weeks for urine pregnancy test (UPT) which, if positive was considered as clinical pregnancy.Results: Out of the total 236 cases, 42 cases had a positive outcome. Out of these 42 positive cases, 27 were from IUTPI group whereas 15 from IUI group. The pregnancy rate was 22.88% in IUTPI and 12.71% in IUI (p=0.039), which was a statistically significant difference. Endometrial thickness, preovulatory follicle number and prewash sperm motility significantly affected positive outcome in IUTPI. Factors like patient’s age, BMI<25, bilateral patent tubes and decreased duration of infertility also positively affected the treatment outcome.Conclusions: Our study found IUTPI to have better pregnancy rate compared to IUI. IUTPI may become a first line option for treatment of infertile patients.


Author(s):  
Monica Soni ◽  
Gajendra Kumar Kalal ◽  
Arti Meena ◽  
Anita Sharma

Background: The objective of this study was to compare clomiphene citrate with letrozole for ovulation induction in anovulatory infertile women.Methods: This study was conducted in the infertility clinic and department of obstetrics and gynecology, S.P. Medical College and Associated P. B. M. Hospital, Bikaner, Rajasthan, from 1st August 2018 to 31st July 2019. The study group comprised of infertile females attending infertility clinic or gynae outdoor in department of obstetrics and gynecology, S. P. Medical College Bikaner for infertility. 100 women with anovulatory infertility were enrolled in the study after fulfilling the inclusion and exclusion criteria. Proper counseling was done and written informed consent taken.Results: Ovulation rate was statistically significantly greater in letrozole group. Monofollicular development was statistically significant greater in let group (CC 18%, Let 66%). The endometrial thickness on the day of ßhCG administration in CC group was 7.40±1.08 mm and in let group was 8.20±0.82 mm. Letrozole treated cases had better trilaminar pattern of endometrium as compared to clomiphene. The pregnancy rate was higher in letrozole group.Conclusions: As compare to clomiphene, letrozole is associated with higher pregnancy rate and ovulation rates among infertile women with anovulation.


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