IVM with Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Transfer for Polycystic Ovary Syndrome

This study is looking at a new way to help women with Polycystic Ovary Syndrome (PCOS) get pregnant using in vitro maturation (IVM). IVM involves collecting immature eggs and letting them mature in the lab before fertilization. This study uses oral medications like letrozole and very low doses of FSH (follicle-stimulating hormone) to prepare the ovaries, and a special needle (Steiner-Tan) for egg retrieval. After fertilization, embryos are frozen and transferred in a later cycle. We want to see how many patients become pregnant after 12 weeks and how many have an ongoing pregnancy after 10 months. You may be able to join if you are a woman between 18 and 38 years old, have a specific pattern of follicles in your ovaries (PCO pattern), and an AMH (Anti-Müllerian Hormone) level above 3.5. We cannot tell you if the study is currently enrolling.

Study design
This is an interventional study with a planned enrollment of 300 participants. All participants will receive the IVM treatment.
What's involved
You will take oral contraceptives, then oral letrozole and low-dose FSH. You will have an HCG injection, followed by egg retrieval approximately 38 hours later. Embryos will be frozen and transferred in a separate cycle.
Compensation
Not stated in the trial record.
Follow-up
Your pregnancy status will be checked at 12 weeks after embryo transfer and again at 10 months after embryo transfer.

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NCT04149496

IVM With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Transfer

Recruiting
NAAges 18–38InterventionalTreatment
Bruce Rose, MD
~300 participants
Updated 2019-11-04 on ClinicalTrials.gov
What's tested:in vitro maturation of oocytes

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of treated patients having a clinical pregnancy
Measured over 12 weeks post transfer
+1 more outcome measured
Polycystic Ovary Syndrome
1 sites across 1 states
Florida1
  • Bruce I Rose, MD, PhD · PRINCIPAL_INVESTIGATOR · Brown Fertility

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Eligibility criteria

Inclusion

PCO pattern with \> 25 antral follicles
AMH \> 3.5

Exclusion

BMI \> 35
body morphology making transvaginal retrieval difficult or impossible
complicating medical condition making pregnancy or IVF relatively contra-indicated
  • Percentage of treated patients having a clinical pregnancy12 weeks post transfer

    ultrasound evidence of pregnancy in uterus or tissue evidence of pregnancy

  • Percentage of treated patients having an ongoing pregnancy10 months post transfer

    pregnancy with cardiac activity (by history or observations) after 12 weeks