Clinical trial NCT01237106: 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
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovarian Syndrome
Keywords: PCOS
IVM
Polycystic ovarian syndrome
In Vitro Maturation
IVF
Lead sponsor: University Reproductive Associates
Sponsor class: OTHER
First posted: 2010-11-09
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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.) -

Primary outcomes:
measure: Incidence of Biochemical Pregnancy (defined as a rising Beta-HCG level).
timeFrame: 6 months
Secondary outcomes:
measure: number of immature oocytes retrieved
timeFrame: 6 months
measure: rates of maturation and fertilization
timeFrame: 6 months
measure: Incidence of Ovarian Hyperstimulation Syndrome (OHSS)
timeFrame: 6 months
measure: live births
timeFrame: 1 1/2 years
Other outcomes:
Locations:
city: Hasbrouck Heights
country: United States
facility: University Reproductive Associates
state: New Jersey
city: Hoboken
country: United States
facility: University Reproductive Associates
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Peter G. McGovern, MD
role: PRINCIPAL_INVESTIGATOR
References: