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Only Gonadotropin Vs. Letrozole Combined Gonadotropin Stimulation in IUI Cycles

NCT ID: NCT06413771

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-02-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Infertility Unexplained

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
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.

Study Groups

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Conventional Only Gonadotropin

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

Group Type ACTIVE_COMPARATOR

Gonadotropin

Intervention Type DRUG

Ovarian stimulation with gonadotropins, in intrauterine insemination cycles.

Combined Letrozole-Gonadotropin group

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

Group Type ACTIVE_COMPARATOR

Letrozole 2.5mg

Intervention Type DRUG

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

Interventions

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Letrozole 2.5mg

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

Intervention Type DRUG

Gonadotropin

Ovarian stimulation with gonadotropins, in intrauterine insemination cycles.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Couples with unexplained infertility
* Aged between 18-35

Exclusion Criteria

* Male factor infertility
* Diminished ovarian reserve
* Patient refusion to participate
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Uludag University

OTHER

Sponsor Role lead

Responsible Party

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GÜRKAN UNCU,PROF. MD

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gurkan Uncu, Prof.

Role: STUDY_CHAIR

Uludag University

Locations

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Uludag University Faculty of Medicine

Bursa, Gorukle, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2022-4/39

Identifier Type: -

Identifier Source: org_study_id

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