etrozole in assisted reproductive techniques protocol

Phase 2

• Conditions: female Infertility.; Female infertility, unspecified; N97.9

• Registration Number: IRCT20110509006420N19
• Lead Sponsor: Yazd University of Medical Sciences

Brief Summary

Abstract Background Aromatase inhibitors prevent the aromatization of androgens into estrogens, which reduces the negative feedback of estrogen on the hypothalamic-pituitary axis. It is clear that increasing the secretion of follicle-stimulating hormones results in an increased follicular growth. Objective This study aimed to evaluate the effect of adding letrozole to gonadotropin on in vitro fertilization outcomes in normal responders. Materials and Methods In this randomized clinical trial, 100 normal responder women candidate for controlled ovarian stimulation were randomly enrolled in two groups (n = 50/each). In the case group letrozole was added to gonadotropin in the antagonist protocol. The control group received the conventional antagonist protocol. The main outcome was clinical and chemical pregnancy; and the second outcomes were the number of mature oocytes, the fertilization rate, estradiol level, and the total dose of gonadotropins. Results Basic clinical and demographic features were comparable between the groups. Estradiol level on the day of human-chorionic-gonadotropin administration and the total gonadotropin consumption were significantly higher in the control group than the case group (p = 0.045). In addition, the number of MII oocytes was higher (but not significantl) in the case group than the control group (p = 0.09). Moreover, the endometrial thickness was significantly lower in the case group. There were no significant differences in fertilization rate and chemical and clinical pregnancy rates between the two groups. Conclusion Although adding letrozole to gonadotropin in normal responders reduces the total dose of gonadotropin, it does not improve the pregnancy outcomes.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Patients referred to the Infertility Center, which is undergoing ovulation induction for assisted reproductive techniques.
normal ovarian reserve

Exclusion Criteria

History of endocrine disorders
Intrauterine abnormality (uterine polyp & sub mucosal fibroma & intrauterine adhesions)
Azoospermia of partner
Severe endometriosis

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chemical pregnancy. Timepoint: 15 days after embryo transfer. Method of measurement: Blood laboratory kit.;Clinical pregnancy. Timepoint: 3 weeks after positive beta-h Cg. Method of measurement: Observation of fetal heart activity by transvaginal ultrasonography.