Luteal Support and Intrauterine Insemination (IUI) With Clomiphene Citrate

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Drug: micronized progesterone

• Registration Number: NCT01046708
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

The purpose of this study is to assess the effect of luteal phase supplement (LPS) on pregnancy rate in IUI cycles stimulated with clomiphene citrate.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2009-08
• Study First Submitted: 2010-01-11
• Study First Submitted QC: 2010-01-11
• Study First Posted: 2010-01-12
• Study Completion: 2012-07
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-01
• Last Update Posted: 2013-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Age ≤ 36 years
• Body mass index between 18 and 29
• Presence of both ovaries
• Basal levels of estradiol (≤ 80 pg/ml) and progesterone (≤ 1.6ng/ml) on day one of the cycle and a day three FSH level of <12IU/L
• Patients can enter the study only once.
• Only the first IUI attempt will be included ( at the 2nd and 3 rd attempt progesterone could be administrated if it is necessary but these attempts will be excluded from the study)
• Normal HSG (maximum 3 months prior starting the stimulation).
• Donor sperm can be included

Exclusion Criteria

• Polycystic ovarian syndrome (Rotterdam criteria)
• Endometriosis(≥AFS III)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
micronized progesterone	micronized progesterone	-

Primary Outcome Measures

Name	Time	Method
ongoing pregnancy rate	1 year

Secondary Outcome Measures

Name	Time	Method
implantation rate,clinical pregnancy rate	1 year