- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01237106
In Vitro Maturation (IVM) for Polycystic Ovary Syndrome (PCOS)
In Vitro Maturation for Polycystic Ovary Syndrome (PCOS)- A Pilot Study
This pilot study will be a prospective investigation to study the efficacy and safety of In-Vitro Maturation (IVM) for women with Polycystic Ovarian Syndrome (PCOS). There will be 10 subjects total in this Study. There will be no blinding to treatment.
In-Vitro Maturation will provide a viable, safe option for women with PCOS attempting pregnancy through the use of Assisted Reproductive Technology (ART).
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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New Jersey
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Hasbrouck Heights, New Jersey, United States, 07604
- University Reproductive Associates
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Hoboken, New Jersey, United States, 07030
- University Reproductive Associates
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- 10 women between the ages of 18-34 inclusive at time of signing Informed Consent Form.
- A diagnosis of PCOS by their primary MD
- An Antral Follicular Count (AFC) of > 12 on one ovary on at least one occasion
- A day 3 FSH level of <8 IU/mL
- In good general health off of current medications which may confound response to study medications.
- Desire to seek pregnancy actively during the study period by IVF-ICSI.
- A normal uterine cavity must have been confirmed by either hydrosonogram or hysteroscopy within two years of entering the study.
- Male partner able to provide adequate semen sample by ejaculation (no TESE)
Exclusion Criteria
- Current pregnancy
- Patients with uncorrected thyroid disease (defined as TSH < 0.2 mIU/ML or >5.5 mIU/mL). A normal level within the last year is adequate for entry.
- Patients with poorly controlled diabetes (HgB A1C over 8.0 ng/dL).
- Patients enrolled simultaneously into other investigative studies that require medications, proscribe the study medications, limit intercourse, or otherwise prevent compliance with the protocol.
- Patients with significant anemia (Hemoglobin < 10 mg/dL).
- Patients enrolled simultaneously into other investigative studies that would interfere with this research study.
- have any contraindications to using birth control pills (oral contraceptives) as determined by the attending physician (e.g. history of thromboembolism or estrogen-dependent malignancy, such as breast cancer, etc.) -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: In Vitro Maturation (IVM)
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all patients in this pilot study will undergo IVM.
IVM involves immature eggs being retrieved and matured in the laboratory.After maturation they are fertilized like is done in a typical IVF cycle.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of Biochemical Pregnancy (defined as a rising Beta-HCG level).
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of immature oocytes retrieved
Time Frame: 6 months
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6 months
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rates of maturation and fertilization
Time Frame: 6 months
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6 months
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Incidence of Ovarian Hyperstimulation Syndrome (OHSS)
Time Frame: 6 months
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6 months
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live births
Time Frame: 1 1/2 years
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1 1/2 years
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Collaborators and Investigators
Investigators
- Principal Investigator: Peter G. McGovern, MD, Rutgers, the State University of New Jersey
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 0120100297
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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CHA UniversityRecruitingNo ConditionKorea, Republic of
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