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Completed

NCT Number: NCT01237106

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

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).

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Key information

Age range

18 year–34 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Reproductive Associates, Hasbrouck Heights, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.) -

Treatment and study plan

IVM

Other

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.

Primary outcomes

  1. Incidence of Biochemical Pregnancy (defined as a rising Beta-HCG level).

    Time frame: 6 months

Secondary outcomes

  1. number of immature oocytes retrieved

    Time frame: 6 months

  2. rates of maturation and fertilization

    Time frame: 6 months

  3. Incidence of Ovarian Hyperstimulation Syndrome (OHSS)

    Time frame: 6 months

  4. live births

    Time frame: 1 1/2 years

Sponsors and collaborators

Lead sponsor

University Reproductive Associates

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 9, 2010
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.