Luteal Support and Intrauterine Insemination (IUI) With Clomiphene Citrate

Infertility Clinical Trial

Official title:

Ovulation Induction With Clomiphene Citrate: to Support or Not to Support the Luteal Phase

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01046708
• Other study ID #: CFER
• Status: Completed
• Phase: N/A
• First received: January 11, 2010
• Last updated: July 1, 2013
• Start date: September 2008
• Est. completion date: July 2012

Study information

• Verified date: July 2013
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 2012
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• micronized progesterone
600mg in 3 separate doses per day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ongoing pregnancy rate		1 year	Yes
Secondary	implantation rate,clinical pregnancy rate		1 year	Yes