In Vitro Maturation (IVM) for Polycystic Ovary Syndrome (PCOS)



Status:Completed
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 34
Updated:4/21/2016
Start Date:November 2010
End Date:November 2012

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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).


Inclusion Criteria

1. 10 women between the ages of 18-34 inclusive at time of signing Informed Consent
Form.

2. A diagnosis of PCOS by their primary MD

3. An Antral Follicular Count (AFC) of > 12 on one ovary on at least one occasion

4. A day 3 FSH level of <8 IU/mL

5. In good general health off of current medications which may confound response to
study medications.

6. Desire to seek pregnancy actively during the study period by IVF-ICSI.

7. A normal uterine cavity must have been confirmed by either hydrosonogram or
hysteroscopy within two years of entering the study.

8. Male partner able to provide adequate semen sample by ejaculation (no TESE)

Exclusion Criteria

1. Current pregnancy

2. 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.

3. Patients with poorly controlled diabetes (HgB A1C over 8.0 ng/dL).

4. Patients enrolled simultaneously into other investigative studies that require
medications, proscribe the study medications, limit intercourse, or otherwise prevent
compliance with the protocol.

5. Patients with significant anemia (Hemoglobin < 10 mg/dL).

6. Patients enrolled simultaneously into other investigative studies that would
interfere with this research study.

7. 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.) -
We found this trial at
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Hoboken, New Jersey 07030
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Hasbrouck Heights, New Jersey 07604
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Hasbrouck Heights, NJ
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