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

Completed · Not applicable

Conditions studied: Polycystic Ovarian Syndrome

In brief

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).

Key facts

Study ID

NCT01237106

Run by

University Reproductive Associates

People needed

10

Starts

2010-11-01

Expected to finish

2012-11-01

Last updated by the study team

2015-12-03

Who can join

Age: 18 and older, up to 34. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.) -

Where it is running

• University Reproductive Associates — Hasbrouck Heights, New Jersey, United States
• University Reproductive Associates — Hoboken, New Jersey, United States

Full record on ClinicalTrials.gov

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