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In Vitro Maturation for Polycystic Ovary Syndrome (PCOS)- A Pilot Study

18 Years
34 Years
Open (Enrolling)
Polycystic Ovarian Syndrome

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Trial Information

In Vitro Maturation for Polycystic Ovary Syndrome (PCOS)- A Pilot Study

Inclusion Criteria

Inclusion Criteria

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

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.) -

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of Biochemical Pregnancy (defined as a rising Beta-HCG level).

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Peter G. McGovern, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Medicine and Dentistry New Jersey


United States: Institutional Review Board

Study ID:

IRB 0120100297



Start Date:

November 2010

Completion Date:

August 2012

Related Keywords:

  • Polycystic Ovarian Syndrome
  • PCOS
  • IVM
  • Polycystic ovarian syndrome
  • In Vitro Maturation
  • IVF
  • Polycystic Ovary Syndrome



University Reproductive Associates Hasbrouck Heights, New Jersey  07604