Back to resultsOvarian Stimulation and Intrauterine Insemination in Women With Polycystic Ovarian Syndrome (OSIPS)
Primary Purpose
Infertility, Polycystic Ovarian Syndrome, Intrauterine Insemination
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Intrauterine insemination (IUI)
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Infertility, PCOS, IUI
Eligibility Criteria
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
Sites / Locations
- Fertility Care Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group A
Group B
Arm Description
controlled ovarian hyperstimulation (COH) and intrauterine insemination (IUI)
Controlled ovarian hyperstimulation (COH)+ Timed Intercourse (TI)
Outcomes
Primary Outcome Measures
Live Birth Rate
Secondary Outcome Measures
Clinical pregnancy rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01675843
Brief Title
Ovarian Stimulation and Intrauterine Insemination in Women With Polycystic Ovarian Syndrome
Acronym
OSIPS
Official Title
Ovarian Stimulation and Intrauterine Insemination in Women With Polycystic Ovarian Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
Yes
5. 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Polycystic Ovarian Syndrome, Intrauterine Insemination
Keywords
Infertility, PCOS, IUI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
controlled ovarian hyperstimulation (COH) and intrauterine insemination (IUI)
Arm Title
Group B
Arm Type
No Intervention
Arm Description
Controlled ovarian hyperstimulation (COH)+ Timed Intercourse (TI)
Intervention Type
Procedure
Intervention Name(s)
Intrauterine insemination (IUI)
Other Intervention Name(s)
IUI
Intervention Description
The male semen is obtained then processed by swim up technique and then introduced into the uterus by special catheter.
Primary Outcome Measure Information:
Title
Live Birth Rate
Time Frame
20 months
Secondary Outcome Measure Information:
Title
Clinical pregnancy rate
Time Frame
16 months
Other Pre-specified Outcome Measures:
Title
multiple pregnancy rate
Time Frame
20 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Gibreel, MD
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fertility Care Unit
City
Mansoura
State/Province
Eldakahlia
ZIP/Postal Code
53111
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Ovarian Stimulation and Intrauterine Insemination in Women With Polycystic Ovarian Syndrome
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