Status:
RECRUITING
Efficiency of Comprehensive Chromosomal Testing of Trophectoderm Biopsies of Blastocysts in In Vitro Fertilization
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Infertility
Eligibility:
All Genders
35-41 years
Phase:
NA
Brief Summary
Preimplantation embryo aneuploidy is a major source of adverse outcomes in human reproduction since it leads to implantation failure, early pregnancy loss or severe chromosomal diseases. The risk of e...
Detailed Description
The presence of chromosomal abnormalities (aneuploidy) in the pre-implantation embryonic stage is one of the major causes of human reproductive disorders, as it is responsible for embryo implantation ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Women :
- Age ≥35 to ≤ 41 years old (according to date of birth at time of informed consent) who are eligible for ovarian stimulation and ART treatment, including intracytoplasmic sperm injection (ICSI)
- BMI=18-35 kg/m2 inclusive
- No intrauterine and/or endometrial abnormalities that would interfere with implantation or pregnancy (for instance polyp, fibroid, …)
- Inclusion Criteria Men:
- Use of ejaculated motile sperm (donated and/or cryopreserved sperm is allowed)
- Age ≤ 50 years old
- Inclusion Criteria Couples:
- Primary or secondary infertility
- Dated and signed inform consent
- Affiliated to National Insurance
- French speaking, able to understand the study
- Criteria after randomization
- Couple having at least one blastocyst with morphological score on Day 5/6 of in vitro embryo development (blastocoel expansion ≥3 and inner cell mass graded A, B or C and trophectoderm graded A or B
- Exclusion Criteria:
- Women:
- Recurrent implantation failure (previous transfer of least 5 good grade blastocysts in at least 3 fresh or frozen cycles)
- Personal history of recurrent miscarriages (more than two miscarriages)
- Altered ovarian reserve: Identified risk of poor ovarian response (history of oocyte puncture with less than 3 oocytes) or AMH\<1.1 ng/mL and AFC\<5)
- Presence of non isolated uni- or bilateral hydrosalpinx
- History or presence of ovarian, uterine or mammary cancer
- Contraindication to being pregnant and/or carrying a pregnancy to term
- Women with uterine polyps diagnosed during COS
- Known allergy or hypersensitivity to human gonadotropin preparations or to compounds that are structurally similar to any of the other medications administered during the trial
- Substance abuse that would interfere with trial conduct, as determined by the investigator
- Pregnant patient, nursing patient
- Men:
- \- Use of testicular or epididymal sperm
- Couples:
- Known infection with human immunodeficiency virus, active hepatitis B or C virus in the female or male partner
- Scheduled for an embryo transfer on day 2 or 3
- Embryo freezing refusal
- Scheduled for a fresh embryo transfer
- Scheduled with an egg donation
- Scheduled with autologous oocytes thawing
- Scheduled for a preimplantation genetic diagnosis
- Participation in another ART clinical trial within the past 30 days
- Participation with another interventional study involving human subjects
- Exlusion criteria to check on randomization day :
- \- Women with less than 3 follicles ≥ 14 mm on the triggering day or the day before the triggering
Exclusion
Key Trial Info
Start Date :
July 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT04758819
Start Date
July 12 2021
End Date
January 1 2026
Last Update
January 19 2024
Active Locations (10)
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1
Hôpital Jean Verdier
Bondy, France, 93
2
Hôpital Antoine Béclère
Clamart, France, 92140
3
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63000
4
CHU Dijon
Dijon, France, 21079