Only Gonadotropin Vs. Letrozole Combined Gonadotropin Stimulation in IUI Cycles

Not Applicable

Completed

• Conditions: Infertility Unexplained
• Interventions: Drug: Gonadotropin; Drug: Letrozole 2.5mg

• Registration Number: NCT06413771
• Lead Sponsor: Uludag University

Brief Summary

The present randomized controlled study aims to investigate the effectiveness of a combined regimen of letrozole and gonadotropin with dose adjustments based on body mass index (BMI) compared to a conventional only gonadotropin regimen in intrauterine insemination (IUI) cycles for couples experiencing unexplained infertility. The study was conducted at a tertiary university hospital's Assisted Reproductive Technologies (ART) center from January 2023 to January 2024. Couples with unexplained infertility were enrolled based on comprehensive assessments, and randomization was performed based on national ID (odd or even). The Conventional Only Gonadotropin (COG) group received recombinant FSH based on body mass index (BMI), while the Combined Letrozole-Gonadotropin (CLG) group received letrozole followed by gonadotropin with dose adjustments based on BMI. Ovulation induction and IUI were performed according to standard protocols. Clinical outcomes, gonadotropin consumption, and pregnancy rates were compared between groups. Among 317 IUI cycles, 131 couples with unexplained infertility were randomized (CLG: 61, COG: 70). Demographic parameters were similar between groups. The CLG group had lower daily gonadotropin doses (67 ± 18 IU/D vs. 76 ± 11 IU/d, p=0.01) and total gonadotropin consumption (750 IU vs. 825 IU, p=0.01) with comparable ovulation and clinical pregnancy rates. The COG group exhibited higher multiple pregnancy rates, although not statistically significant (CLG vs. COG; 1/61 vs. 3/70, p=0.4). The study suggests that the combined letrozole and gonadotropin regimen with BMI-based dose adjustments in IUI cycles for unexplained infertility is associated with reduced gonadotropin consumption and potentially lower multiple pregnancy rates.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-02-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-09
• Study First Submitted QC: 2024-05-09
• Last Update Submitted: 2024-05-09
• Study First Posted: 2024-05-14
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 131

Inclusion Criteria

• Couples with unexplained infertility
• Aged between 18-35

Exclusion Criteria

• Male factor infertility
• Diminished ovarian reserve
• Patient refusion to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Only Gonadotropin	Gonadotropin	The Conventional Only Gonadotropin (COG) group received recombinant FSH based on body mass index (BMI)
Combined Letrozole-Gonadotropin group	Letrozole 2.5mg	The combined Letrozole-Gonadotropin (CLG) group received letrozole followed by gonadotropin with dose adjustments based on BMI.

Primary Outcome Measures

Name	Time	Method
Clinical Pregnancy Rate	6 weeks	Presence of gestational sac by transvaginal ultrasound

Secondary Outcome Measures

Name	Time	Method
Multiple Pregnancy Rate	6 weeks	Presence of multipl gestational sacs by transvaginal ultrasound

Trial Locations

Locations (1)

Uludag University Faculty of Medicine; 🇹🇷 Bursa, Gorukle, Turkey