Polycystic Ovarian Syndrome
Conditions
Keywords
PCOS, IVM, Polycystic ovarian syndrome, In Vitro Maturation, IVF
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).
Interventions
OTHERIVM
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.
Sponsors
University Reproductive Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 34 Years
Healthy volunteers
Yes
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.) -
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Biochemical Pregnancy (defined as a rising Beta-HCG level). | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| live births | 1 1/2 years |
| number of immature oocytes retrieved | 6 months |
| rates of maturation and fertilization | 6 months |
| Incidence of Ovarian Hyperstimulation Syndrome (OHSS) | 6 months |
Countries
United States
Outcome results
None listed