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

Primary Purpose

Polycystic Ovarian Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IVM
Sponsored by
University Reproductive Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovarian Syndrome focused on measuring PCOS, IVM, Polycystic ovarian syndrome, In Vitro Maturation, IVF

Eligibility Criteria

18 Years - 34 Years (Adult)FemaleAccepts Healthy Volunteers

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.) -

Sites / Locations

  • University Reproductive Associates
  • University Reproductive Associates

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

In Vitro Maturation (IVM)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

number of immature oocytes retrieved
rates of maturation and fertilization
Incidence of Ovarian Hyperstimulation Syndrome (OHSS)
live births

Full Information

First Posted
November 3, 2010
Last Updated
December 1, 2015
Sponsor
University Reproductive Associates
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1. Study Identification

Unique Protocol Identification Number
NCT01237106
Brief Title
In Vitro Maturation (IVM) for Polycystic Ovary Syndrome (PCOS)
Official Title
In Vitro Maturation for Polycystic Ovary Syndrome (PCOS)- A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Reproductive Associates

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovarian Syndrome
Keywords
PCOS, IVM, Polycystic ovarian syndrome, In Vitro Maturation, IVF

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
In Vitro Maturation (IVM)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
IVM
Intervention Description
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 Outcome Measure Information:
Title
Incidence of Biochemical Pregnancy (defined as a rising Beta-HCG level).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
number of immature oocytes retrieved
Time Frame
6 months
Title
rates of maturation and fertilization
Time Frame
6 months
Title
Incidence of Ovarian Hyperstimulation Syndrome (OHSS)
Time Frame
6 months
Title
live births
Time Frame
1 1/2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.) -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter G. McGovern, MD
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Reproductive Associates
City
Hasbrouck Heights
State/Province
New Jersey
ZIP/Postal Code
07604
Country
United States
Facility Name
University Reproductive Associates
City
Hoboken
State/Province
New Jersey
ZIP/Postal Code
07030
Country
United States

12. IPD Sharing Statement

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

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