Only Gonadotropin Vs. Letrozole Combined Gonadotropin Stimulation in IUI Cycles

NCT06413771 | Completed

• 1 other identifier: 2022-4/39
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility Unexplained

Keywords

unexplained infertility; letrozole; gonadotropin; intrauterine insemination

Outcome Measures

Primary Outcomes (1)

• Clinical Pregnancy Rate

  Presence of gestational sac by transvaginal ultrasound

  6 weeks

Secondary Outcomes (1)

• Multiple Pregnancy Rate

  6 weeks

Study Arms (2)

Conventional Only Gonadotropin

ACTIVE COMPARATOR

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

Drug: Gonadotropin

Combined Letrozole-Gonadotropin group

ACTIVE COMPARATOR

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

Drug: Letrozole 2.5mg

Interventions

Letrozole 2.5mg DRUG

Letrozole pretreatment during ovarian stimulation with gonadotropins, in intrauterine insemination cycles.

Combined Letrozole-Gonadotropin group

Gonadotropin DRUG

Ovarian stimulation with gonadotropins, in intrauterine insemination cycles.

Conventional Only Gonadotropin

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Couples with unexplained infertility
• Aged between 18-35

You may not qualify if:

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

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Uludag University Faculty of Medicine

Bursa, Gorukle, 16085, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Letrozole; Gonadotropins

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Gurkan Uncu, Prof.

  Uludag University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 14, 2024
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

TU (1)