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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter McGovern, MD, University Reproductive Associates
ClinicalTrials.gov Identifier:
NCT01237106
First received: November 3, 2010
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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 Intervention
Polycystic Ovarian Syndrome
Other: IVM

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: In Vitro Maturation for Polycystic Ovary Syndrome (PCOS)- A Pilot Study

Resource links provided by NLM:


Further study details as provided by University Reproductive Associates:

Primary Outcome Measures:
  • Incidence of Biochemical Pregnancy (defined as a rising Beta-HCG level). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of immature oocytes retrieved [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • rates of maturation and fertilization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Incidence of Ovarian Hyperstimulation Syndrome (OHSS) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • live births [ Time Frame: 1 1/2 years ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: November 2010
Study Completion Date: November 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 34 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.) -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01237106

Locations
United States, New Jersey
University Reproductive Associates
Hasbrouck Heights, New Jersey, United States, 07604
University Reproductive Associates
Hoboken, New Jersey, United States, 07030
Sponsors and Collaborators
University Reproductive Associates
Investigators
Principal Investigator: Peter G. McGovern, MD Rutgers, The State University of New Jersey
  More Information

No publications provided

Responsible Party: Peter McGovern, MD, Medical Director, University Reproductive Associates
ClinicalTrials.gov Identifier: NCT01237106     History of Changes
Other Study ID Numbers: IRB 0120100297
Study First Received: November 3, 2010
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University Reproductive Associates:
PCOS
IVM
Polycystic ovarian syndrome
In Vitro Maturation
IVF

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 21, 2014