Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413771
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2024-05-09
Brief Title:
Only Gonadotropin Vs Letrozole Combined Gonadotropin Stimulation in IUI Cycles
Sponsor:
Uludag University
Organization:
Uludag University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 hospitals 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 IUD vs 76 11 IUd p001 and total gonadotropin consumption 750 IU vs 825 IU p001 with comparable ovulation and clinical pregnancy rates The COG group exhibited higher multiple pregnancy rates although not statistically significant CLG vs COG 161 vs 370 p04 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None