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

Sponsor

University Reproductive Associates (Other)

Overall Status

Completed

CT.gov ID

NCT01237106

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovarian Syndrome	Other: IVM	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: In Vitro Maturation (IVM)	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.

Arm

Intervention/Treatment

Experimental: In Vitro Maturation (IVM)

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.

Outcome Measures

Primary Outcome Measures

Incidence of Biochemical Pregnancy (defined as a rising Beta-HCG level). [6 months]

Secondary Outcome Measures

number of immature oocytes retrieved [6 months]
rates of maturation and fertilization [6 months]
Incidence of Ovarian Hyperstimulation Syndrome (OHSS) [6 months]
live births [1 1/2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 34 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria

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)

Exclusion Criteria

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.) -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Reproductive Associates	Hasbrouck Heights	New Jersey	United States	07604
2	University Reproductive Associates	Hoboken	New Jersey	United States	07030