Intrauterine Insemination and Luteal Fase Support

Phase 4

Completed

• Conditions: Infertility
• Interventions: Drug: crinone (progesterone 8%, vaginal application)

• Registration Number: NCT01826747
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

The objective is to test the hypothesis that luteal phase support with vaginal progesterone leads to a higher clinical pregnancy rate (primary outcome) and live birth rate (secondary outcome) when compared to no luteal phase support in a program of intrauterine insemination (IUI) after controlled ovarian stimulation with gonadotrophins. Additionally, the length of the luteal phase will be recorded (secondary outcome) in order to detect luteal phase defects/insufficiencies in the absence of luteal phase suppletion as well as luteal phase prolongation in case of luteal phase support which may be a burden for the patients waiting for the outcome of the treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2013-02-25
• Study First Submitted QC: 2013-04-05
• Study First Posted: 2013-04-08
• Primary Completion: 2015-01
• Study Completion: 2016-06
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-17
• Last Update Posted: 2018-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 393

Inclusion Criteria

Patients with an indication for IUI:

• unexplained infertility
• mild male factor infertility
• minimal-mild endometriosis

Women:

• first IUI cycle ever
• normal ovulatory cycles (26-32d)
• age<43,BMI≤30
• presence of at least one patent tube on hysterosalpingography and/or laparoscopy
• normal uterine cavity (ultrasound, hysterosalpingography, or laparoscopy)

Men: Total motile count ≥ 5 Million/ml after capacitation

Exclusion Criteria

• Patients with contra-indication for pregnancy , infertility or progesterone use.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental	crinone (progesterone 8%, vaginal application)	Luteal Phase support

Primary Outcome Measures

Name	Time	Method
clinical pregnancy rate per IUI cycle	by ultrasound at ± 5 to 6 weeks after IUI

Secondary Outcome Measures

Name	Time	Method
live birth rate per IUI cycle	40 weeks after IUI

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium