- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02456792
IVF Versus LOD in Women With CC Resistant PCOS
May 8, 2017 updated by: Mohamed Sayed Abdelhafez
In Vitro Fertilization Versus Laparoscopic Ovarian Drilling in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome
The purpose of this study is to compare the efficacy of in vitro fertilization (IVF) versus laparoscopic ovarian drilling (LOD) in infertile women having clomiphene citrate (CC) resistant polycystic ovarian syndrome (PCOS).
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
Women will be randomly divided into two groups; IVF group and LOD group.
Women in the IVF group will undergo one full IVF cycle.
Women in the LOD group will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months.
Study Type
Interventional
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
-
-
Dakahlia
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Mansoura, Dakahlia, Egypt, 35111
- Fertility Care Unit (FCU) in Mansoura University Hospital
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Mansoura, Dakahlia, Egypt
- Private fertility care centers
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-
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
20 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Infertile women with PCOS as defined by the Rotterdam criteria.
- CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles).
Exclusion Criteria:
- Age < 20 or > 35 years.
- Presence of any infertility factor other than anovulatory PCOS.
- Previous history of ovarian surgery or surgical removal of one ovary.
- Previous exposure to cytotoxic drugs or pelvic irradiation.
- Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months.
- Metabolic or hormonal abnormalities.
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: IVF group
Women will undergo one full IVF cycle
|
Women will undergo one IVF cycle
Other Names:
|
Active Comparator: LOD group
Women will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months
|
Women will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Live birth rate
Time Frame: 9 months
|
Number of live births divided by the number of women
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Miscarriage rate
Time Frame: 12 weeks gestational age
|
Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies
|
12 weeks gestational age
|
Incidence of early ovarian hyperstimulation syndrome (OHSS)
Time Frame: Within 9 days of final triggering of oocyte maturation
|
Incidence of OHSS within 9 days of final triggering of oocyte maturation
|
Within 9 days of final triggering of oocyte maturation
|
Clinical pregnancy rate
Time Frame: 6-8 weeks gestational age
|
Number of clinical pregnancies divided by the number of women
|
6-8 weeks gestational age
|
Multifetal pregnancy rate
Time Frame: 12 weeks gestational age
|
Number of multifetal pregnancies divided by the number of clinical pregnancies
|
12 weeks gestational age
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ahmed Gibreel, Dr, Mansoura University
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
January 1, 2016
Primary Completion (Anticipated)
April 1, 2017
Study Completion (Anticipated)
May 1, 2017
Study Registration Dates
First Submitted
May 23, 2015
First Submitted That Met QC Criteria
May 28, 2015
First Posted (Estimate)
May 29, 2015
Study Record Updates
Last Update Posted (Actual)
May 10, 2017
Last Update Submitted That Met QC Criteria
May 8, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AG1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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