Clinical trial

Comparison of Two Ovarian Stimulation Strategies in Intrauterine Insemination Cycles of Couples With Unexplained Infertility; Only Gonadotropin Vs. Letrozole Combined Gonadotropin Stimulation. A Randomized Controlled Trial.

Name
2022-4/39
Description
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.
Trial arms
Trial start
2023-01-01
Estimated PCD
2024-01-01
Trial end
2024-02-01
Status
Completed
Treatment
Letrozole 2.5mg
Letrozole pretreatment during ovarian stimulation with gonadotropins, in intrauterine insemination cycles.
Arms:
Combined Letrozole-Gonadotropin group
Gonadotropin
Ovarian stimulation with gonadotropins, in intrauterine insemination cycles.
Arms:
Conventional Only Gonadotropin
Size
131
Primary endpoint
Clinical Pregnancy Rate
6 weeks
Eligibility criteria
Inclusion Criteria: * Couples with unexplained infertility * Aged between 18-35 Exclusion Criteria: * Male factor infertility * Diminished ovarian reserve * Patient refusion to participate
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': "Patients were divided into two study arms based on the initial digits of their national IDs by ART nurses. Importantly, the IVF clinicians remained blinded to the patients' grouping throughout the study.", 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 131, 'type': 'ACTUAL'}}
Updated at
2024-05-14

1 organization

2 products

1 indication

Organization
Uludag University
Product
Letrozole