Ovarian Stimulation and Intrauterine Insemination in Women With Polycystic Ovarian Syndrome

Phase 4

Completed

• Conditions: Infertility; Polycystic Ovarian Syndrome; Intrauterine Insemination
• Interventions: Procedure: Intrauterine insemination (IUI)

• Registration Number: NCT01675843
• Lead Sponsor: Mansoura University

Brief Summary

The study null hypothethesis is: intrauterine insemination (IUI) does not improve pregnancy rates in women with polycystic ovary syndrome. Infertile women with pcos will receive gonadotropins for ovarian stimulation and then randomize to either IUI or timed intercourse (TI)

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2012-03
• Status Verified: 2012-08
• Study First Submitted: 2012-08-28
• Study First Submitted QC: 2012-08-28
• Last Update Submitted: 2012-08-28
• Study First Posted: 2012-08-30
• Last Update Posted: 2012-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

• women who failed to get pregnant after 6 ovulation induction cycles with clomiphene citrate (cc) alone, despite of being ovulating with cc, having patent Fallopian tubes as confirmed by hysterosalpingography and their partners had fertile semen parameters according to criteria of World Health Organization (WHO 2010)

Exclusion Criteria

male factor infertility

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Intrauterine insemination (IUI)	controlled ovarian hyperstimulation (COH) and intrauterine insemination (IUI)

Primary Outcome Measures

Name	Time	Method
Live Birth Rate	20 months

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	16 months

Trial Locations

Locations (1)

Fertility Care Unit; 🇪🇬 Mansoura, Eldakahlia, Egypt