Luteal Support and Intrauterine Insemination (IUI) With Clomiphene Citrate

Universitair Ziekenhuis Brussel

Status: Completed

Conditions: Infertility

Treatments: Drug: micronized progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT01046708

CFER

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: Female

Ages: 18 to 36 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

micronized progesterone

Experimental group

Treatment:

Drug: micronized progesterone

no utrogestan

No Intervention group