- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01675843
Ovarian Stimulation and Intrauterine Insemination in Women With Polycystic Ovarian Syndrome (OSIPS)
August 28, 2012 updated by: Ahmed Gibreel, Mansoura University
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)
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
140
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Eldakahlia
-
Mansoura, Eldakahlia, Egypt, 53111
- Fertility Care Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
controlled ovarian hyperstimulation (COH) and 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:
|
No Intervention: Group B
Controlled ovarian hyperstimulation (COH)+ Timed Intercourse (TI)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Live Birth Rate
Time Frame: 20 months
|
20 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical pregnancy rate
Time Frame: 16 months
|
16 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
multiple pregnancy rate
Time Frame: 20 months
|
20 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
August 28, 2012
First Submitted That Met QC Criteria
August 28, 2012
First Posted (Estimate)
August 30, 2012
Study Record Updates
Last Update Posted (Estimate)
August 30, 2012
Last Update Submitted That Met QC Criteria
August 28, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AG/4/2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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