Overture Semi-automated Vitrification System for Oocyte Cryopreservation
This study is testing a new medical device called the Overture Semi-Automated Vitrification System, also known as "DaVitri." This system aims to make the process of freezing human eggs (oocyte cryopreservation) semi-automated. Researchers want to see if using the DaVitri System results in similar clinical pregnancy rates compared to the standard manual method of freezing eggs. The study is looking for women between 18 and 45 years old who are either donating eggs or receiving donated eggs as part of an in-vitro fertilization (IVF) cycle. For egg donors, you should be between 18-35 years old with a specific AMH range (a hormone level related to egg supply). The main goal is to compare pregnancy rates after using eggs frozen with the DaVitri system versus the standard method. The study plans to enroll 260 participants.
- Study design
- This is an interventional study comparing the DaVitri System to the standard manual process for freezing eggs. It plans to enroll 260 female recipients and up to 130 egg donors.
- What's involved
- Donors will provide informed consent before egg retrieval. After retrieval, eggs will be processed and randomly divided for freezing using either the DaVitri system or the standard method.
- Compensation
- Not stated in the trial record.
- Follow-up
- Clinical pregnancy rates will be measured from enrollment up to 6-7 weeks.
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Paired Non-inferiority Study Comparing Overture Semi-automated Vitrification System ("DaVitri") to Standard Manual Process for Clinical Pregnancy Outcomes
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Clinical Pregnancy RateFrom enrollment to 6-7 weeks
Presence of sac in uterus and chemical confirmation at 6-7 weeks