Status:
COMPLETED
In Vitro Maturation (IVM) for Polycystic Ovary Syndrome (PCOS)
Lead Sponsor:
University Reproductive Associates
Conditions:
Polycystic Ovarian Syndrome
Eligibility:
FEMALE
18-34 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.) -
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01237106
Start Date
November 1 2010
End Date
November 1 2012
Last Update
December 3 2015
Active Locations (2)
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1
University Reproductive Associates
Hasbrouck Heights, New Jersey, United States, 07604
2
University Reproductive Associates
Hoboken, New Jersey, United States, 07030