Improving pregnancy outcomes in women with PCOS using a new oocyte retrieval method
A Prospective Series of IVF Cases Utilizing in Vitro Maturation (IVM) With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Embryo Transfer Using a Subsequent Frozen Embryo Transfer Cycle
This study is testing a new way to help women with PCOS get pregnant by using a special method to collect eggs and see if it improves their chances of having a baby.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 38 Years |
| Sex | Female |
| Sponsor | Brown Fertility Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT04149496 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance pregnancy results for women with Polycystic Ovary Syndrome (PCOS) by utilizing a novel protocol for in vitro maturation (IVM) of oocytes. The approach includes the use of a Steiner-Tan needle for optimized oocyte retrieval, oral medications for priming, and delayed embryo transfer after cryopreservation. Participants will undergo a cycle of IVM following a regimen of oral contraceptives and letrozole, with oocyte retrieval timed for optimal maturity. The study seeks to assess the effectiveness of this method compared to existing literature on IVM outcomes.
Who should consider this trial
Good fit: Ideal candidates are women diagnosed with PCOS or those exhibiting a PCO pattern with more than 25 antral follicles.
Not a fit: Patients with a BMI over 35 or those with medical conditions that contraindicate pregnancy or IVF may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve pregnancy rates for women with PCOS undergoing IVM.
How similar studies have performed: While there have been studies on IVM, this specific approach using the Steiner-Tan needle and the outlined protocol is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * PCO pattern with \> 25 antral follicles * AMH \> 3.5 Exclusion Criteria: * BMI \> 35 * body morphology making transvaginal retrieval difficult or impossible * complicating medical condition making pregnancy or IVF relatively contra-indicated
Where this trial is running
Jacksonville, Florida
- Brown Fertility — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Bruce I Rose, MD, PhD — Brown Fertility
- Study coordinator: Bruce I Rose, MD, PhD
- Email: brose@brownfertility.com
- Phone: 904-260-0352
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.