NCT01237106

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2010

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

1.3 years

First QC Date

November 3, 2010

Last Update Submit

December 1, 2015

Conditions

Polycystic Ovarian Syndrome

Keywords

PCOSIVMPolycystic ovarian syndromeIn Vitro MaturationIVF

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (4)

  • 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

Study Arms (1)

In Vitro Maturation (IVM)

EXPERIMENTAL
Other: IVM

Interventions

IVMOTHER

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.

In Vitro Maturation (IVM)

Eligibility Criteria

Age18 Years - 34 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.) -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Reproductive Associates

Hasbrouck Heights, New Jersey, 07604, United States

Location

University Reproductive Associates

Hoboken, New Jersey, 07030, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Peter G. McGovern, MD

    Rutgers, The State University of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

November 3, 2010

First Posted

November 9, 2010

Study Start

November 1, 2010

Primary Completion

February 1, 2012

Study Completion

November 1, 2012

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

US(2)