Only Gonadotropin Vs. Letrozole Combined Gonadotropin Stimulation in IUI Cycles

Infertility Unexplained Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06413771
• Other study ID #: 2022-4/39
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: May 2024
• Source: Uludag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: February 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Couples with unexplained infertility

• Aged between 18-35

Exclusion Criteria:

• Male factor infertility

• Diminished ovarian reserve

• Patient refusion to participate

Related Conditions & MeSH terms

• Infertility
• Infertility Unexplained

Intervention

Drug:
• Letrozole 2.5mg
Letrozole pretreatment during ovarian stimulation with gonadotropins, in intrauterine insemination cycles.
• Gonadotropin
Ovarian stimulation with gonadotropins, in intrauterine insemination cycles.

Locations

Country	Name	City	State
Turkey	Uludag University Faculty of Medicine	Bursa	Gorukle

Sponsors (1)

Lead Sponsor	Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Pregnancy Rate	Presence of gestational sac by transvaginal ultrasound	6 weeks
Secondary	Multiple Pregnancy Rate	Presence of multipl gestational sacs by transvaginal ultrasound	6 weeks