Impact of luteal phase support with vaginal progesterone on the clinical pregnancy rate in IUI cycles stimulated with gonadotrophins: a prospective randomized multicentre study. - Luteal Phase and IUI

Phase 1

• Conditions: Subfertility; MedDRA version: 12.1Level: LLTClassification code 10042391Term: Subfertility; MedDRA version: 12.1Level: LLTClassification code 10042392Term: Subfertility (female)

• Registration Number: EUCTR2010-023867-17-BE
• Lead Sponsor: niversity Hospital Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-01
• Study Completion: 2015-10-22
• Last Update Posted: 30 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 393

Inclusion Criteria

Women: Normo-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: Sperm sample with a total motile count = 5 Miljon/ml after capacitation

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with a contra indication for the use of crinone :
Known hypersensitivity to progesterone or one of the components of Crinone, vaginal bleeding of unknown origin, known or suspected malignancy of the breast or the reproductive system, acute porphyria, meningioma, patients with a history of or experiencing thrombophlebitis, trombo-embolic disease or cerebrovascular accident, non-ongoing pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified