Fertilo In Vitro Research Study
This study is testing a new approach called Fertilo for In Vitro Maturation (IVM), a process where eggs mature outside the body. Researchers want to see if Fertilo, which uses special ovarian support cells, is better than the currently approved MediCult IVM system for helping eggs mature. You may be eligible if you are a woman between 18 and 35 years old, have a BMI between 21-40, and are a candidate for IVF. The study will compare the number of ongoing pregnancies at 12 weeks of gestation between participants who use Fertilo and those who use MediCult IVM. The study aims to enroll 500 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional study planning to enroll 500 women. Participants will be divided into two groups, with one group using Fertilo and the other using MediCult IVM for egg maturation.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome, ongoing pregnancy, will be measured at 12 weeks gestation.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Fertilo In Vitro Research Study and Trial
At a glance
Conditions
Where it's being run
15 sites across 7 statesWho to contact
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What this trial measures
- Demonstration of the superiority of Fertilo compared to the currently approved MediCult IVM® for infertility treatment via IVF procedures.12 weeks gestation
Cumulative ongoing pregnancy from cycles initiated within 6 months post-randomization. The primary endpoint of ongoing pregnancy is assessed at 12 weeks gestation or later. Cumulative ongoing pregnancy is determined using the cumulative outcome of up to the first two embryo transfers. Subjects with a detectable fetal heartbeat, considered normal and healthy, are considered as having achieved an ongoing pregnancy. "Normal" will be determined as expected for the gestational age ranging from 110 bpm to 180 bpm and measured via ultrasound. Ongoing pregnancy is recorded as either a Yes or No for normal fetal heart rate present for each of the Subject's transfer cycles. Subjects without an ongoing pregnancy assessment are considered as a No unless a later observation indicates otherwise (i.e., a live birth). Cumulative ongoing pregnancy is derived as either a Yes, if at least one of the first two embryo transfers achieves an ongoing pregnancy, or a No otherwise.