Clinical trial · Interventional
In Vitro Maturation (IVM) for Polycystic Ovary Syndrome (PCOS)
In Vitro Maturation for Polycystic Ovary Syndrome (PCOS)- A Pilot Study
NCT01237106CI-TRIAL-00020042completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovarian Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IVM | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- In Vitro Maturation (IVM)
- interventionNames
- Other: IVM
Primary outcomes (1)
- measure
- Incidence of Biochemical Pregnancy (defined as a rising Beta-HCG level).
- timeFrame
- 6 months
Secondary outcomes (4)
- measure
- number of immature oocytes retrieved
- timeFrame
- 6 months
- measure
- rates of maturation and fertilization
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 34 Years
Show eligibility criteria text
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.) -
References
Publications (0)
Data not yet available
No reference posted for this study.