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

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

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).

Study Overview

• Status: Completed
• Conditions: Polycystic Ovarian Syndrome
• Intervention / Treatment: Other: IVM

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Hasbrouck Heights, New Jersey, United States, 07604
      • University Reproductive Associates
    • Hoboken, New Jersey, United States, 07030
      • University Reproductive Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 34 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Biochemical Pregnancy (defined as a rising Beta-HCG level).	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Reproductive Associates
• Investigators: Principal Investigator: Peter G. McGovern, MD, Rutgers, The State University of New Jersey

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: November 3, 2010
• First Submitted That Met QC Criteria: November 8, 2010
• First Posted (Estimate): November 9, 2010

Study Record Updates

• Last Update Posted (Estimate): December 3, 2015
• Last Update Submitted That Met QC Criteria: December 1, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: IVF; PCOS; IVM; Polycystic ovarian syndrome; In Vitro Maturation
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: IRB 0120100297