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

University Reproductive Associates

Status: Completed

Conditions: Polycystic Ovarian Syndrome

Treatments: Other: IVM

Study type: Interventional

Funder types: Other

Identifiers

NCT01237106

IRB 0120100297

Details and patient eligibility

About

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).

Enrollment: 10 patients

Sex: Female

Ages: 18 to 34 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.) -

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

In Vitro Maturation (IVM)

Experimental group

Treatment:

Other: IVM