OSIPS: Ovarian Stimulation and Intrauterine Insemination in Women With Polycystic Ovarian Syndrome

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT01675843

Collaborator

(none)

140

Enrollment

Location

Arms

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Infertility Polycystic Ovarian Syndrome Intrauterine Insemination	Procedure: Intrauterine insemination (IUI)	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Ovarian Stimulation and Intrauterine Insemination in Women With Polycystic Ovarian Syndrome

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A controlled ovarian hyperstimulation (COH) and intrauterine insemination (IUI)	Procedure: Intrauterine insemination (IUI) The male semen is obtained then processed by swim up technique and then introduced into the uterus by special catheter. Other Names: IUI
No Intervention: Group B Controlled ovarian hyperstimulation (COH)+ Timed Intercourse (TI)

Arm

Intervention/Treatment

Experimental: Group A

controlled ovarian hyperstimulation (COH) and intrauterine insemination (IUI)

Procedure: Intrauterine insemination (IUI)

The male semen is obtained then processed by swim up technique and then introduced into the uterus by special catheter.

Other Names:

IUI

No Intervention: Group B

Controlled ovarian hyperstimulation (COH)+ Timed Intercourse (TI)

Outcome Measures

Primary Outcome Measures

Live Birth Rate [20 months]

Secondary Outcome Measures

Clinical pregnancy rate [16 months]

Other Outcome Measures

multiple pregnancy rate [20 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 38 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)