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Paired Non-inferiority Study Comparing Overture Semi-automated Vitrification System ("DaVitri") to Standard Manual Process for Clinical Pregnancy Outcomes

RecruitingNAAges 18 Years - 45 YearsFemaleOverture Life
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In plain words

What the trial is, and whether it could suit you

This study will recruit 260 female recipients (and up to a maximum of 130 donors). This study is a sequel to the protocol CP-DV-000-GEN-003, entitled, "NON-INFERIORITY STUDY COMPARING OVERTURE SEMI-AUTOMATED VITRIFICATION SYSTEM ("DaVitri") TO STANDARD MANUAL PROCESS USING BLASTOCYST RATE AS THE PRIMARY END POINT". Donors will provide informed consent and will be enrolled before egg retrieval. Once the oocytes are retrieved, they will undergo thorough denudation to remove corona cells and will be assessed for maturity. Subsequently, mature MII oocytes exhibiting good morphology, as per the Vienna Consensus, ranging between 12 and 30 in number, will be processed. These oocytes will then be randomly divided into groups comprising 6 to 8 oocytes each. Therefore, from a single donor, 2 to 4 groups can be generated. An identifier will be assigned for each group. One of the groups will be ra

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: \- Inclusion Criteria (donors) Ages 18-35 AMH range (2-10) ng/ml Healthy females (no pre-existing medical conditions) Inclusion Criteria (recipient) Undergoing an in-vitro fertilization (IVF) cycle with egg donation Premenopausal female, 18-45 years of age Normal uterine cavity Single embryo transfer Exclusion Criteria: \- Exclusion Criteria (donors) Age \>35 years of age BMI \<18.5 or \>25 Infertility history Three previously failed IVF cycles, including abortions. Abnormal ovulation cycle FSH \>10 or AMH \<2 Alcoholism, drug addiction Infectious diseases (such as HIV, hepatitis, sexually transmitted infections) Donors producing less than 12 mature oocytes of good quality (according to Vienna Consensus criteria) Sperm Exclusion Criteria Severe male factor Infertility (unless donated sperm is used) Alcoholism, drug addiction Exclusion Criteria (recipients) Age \>45 years of age BMI \<18.5 or \>29 Patients using a surrogate. Evidence of uterine pathologies Severe male factor Infertility (unless donated sperm is used) Alcoholism, drug addiction Infectious diseases (such as HIV, hepatitis, sexually transmitted infections)
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What it tests

  • Oocyte Cryopreservation
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Where

1 site
Lane Fertility Institute
Novato, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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