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NCT01675843 Clinical Trial

Ovarian Stimulation and Intrauterine Insemination in Women With Polycystic Ovarian Syndrome

Infertility Clinical Trial

— OSIPS  

Official title:
Ovarian Stimulation and Intrauterine Insemination in Women With Polycystic Ovarian Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01675843
Other study ID # AG/4/2010
Secondary ID
Status Completed
Phase Phase 4
First received August 28, 2012
Last updated August 28, 2012
Start date May 2010

Study information
Verified date August 2012
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority Egypt: Ministry of Higher Education
Study type Interventional

Clinical Trial 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)

Recruitment information / eligibility
Status Completed
Enrollment 140
Est. completion date
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Female
Age group 21 Years to 38 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Intrauterine insemination (IUI)
The male semen is obtained then processed by swim up technique and then introduced into the uterus by special catheter.

Locations
Country Name City State
Egypt Fertility Care Unit Mansoura Eldakahlia

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Other multiple pregnancy rate 20 months Yes
Primary Live Birth Rate 20 months No
Secondary Clinical pregnancy rate 16 months No
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