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

Polycystic Ovarian Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01237106
• Other study ID #: IRB 0120100297
• Status: Completed
• Phase: N/A
• First received: November 3, 2010
• Last updated: December 1, 2015
• Start date: November 2010
• Est. completion date: November 2012

Study information

• Verified date: December 2015
• Source: University Reproductive Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

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.) -

Study Design

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

Related Conditions & MeSH terms

• Polycystic Ovarian Syndrome
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Other:
• IVM
all patients in this pilot study will undergo IVM. IVM involves immature eggs being retrieved and matured in the laboratory.After maturation they are fertilized like is done in a typical IVF cycle.

Locations

Country	Name	City	State
United States	University Reproductive Associates	Hasbrouck Heights	New Jersey
United States	University Reproductive Associates	Hoboken	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
University Reproductive Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Biochemical Pregnancy (defined as a rising Beta-HCG level).		6 months	No
Secondary	number of immature oocytes retrieved		6 months	No
Secondary	rates of maturation and fertilization		6 months	No
Secondary	Incidence of Ovarian Hyperstimulation Syndrome (OHSS)		6 months	Yes
Secondary	live births		1 1/2 years	Yes