Only Gonadotropin Vs. Letrozole Combined Gonadotropin Stimulation in IUI Cycles

Bursa Uludag University

Status: Completed

Conditions: Infertility Unexplained

Treatments: Drug: Gonadotropin; Drug: Letrozole 2.5mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06413771

2022-4/39

Details and patient eligibility

About

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.

Enrollment: 131 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Couples with unexplained infertility
• Aged between 18-35

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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131 participants in 2 patient groups

Conventional Only Gonadotropin

Active Comparator group

Description:

The Conventional Only Gonadotropin (COG) group received recombinant FSH based on body mass index (BMI)

Treatment:

Drug: Gonadotropin

Combined Letrozole-Gonadotropin group

Active Comparator group

Description:

The combined Letrozole-Gonadotropin (CLG) group received letrozole followed by gonadotropin with dose adjustments based on BMI.

Treatment:

Drug: Letrozole 2.5mg