Testing embryo biopsies to improve IVF success rates
Comprehensive Chromosomal Testing of Trophectoderm Biopsies of Blastocysts to Improve Live Birth Rates After in Vitro Fertilization: a Prospective Randomized Trial
NA · Assistance Publique - Hôpitaux de Paris · NCT04758819
This study is testing if a new way of checking embryos can help women aged 35 to 41 have more successful pregnancies through IVF.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 700 (estimated) |
| Ages | 35 Years to 41 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 10 sites (Bondy and 9 other locations) |
| Trial ID | NCT04758819 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Comprehensive Chromosomal Testing of Trophectoderm biopsies from blastocysts in improving live birth rates for women aged 35 to 41 undergoing in vitro fertilization (IVF). The study aims to compare outcomes between traditional embryo selection methods and those utilizing next-generation sequencing to identify euploid embryos. By focusing on older couples facing infertility, the trial seeks to provide a more reliable approach to embryo selection, potentially reducing miscarriage rates and increasing successful pregnancies. Participants will undergo a randomized controlled trial to assess the impact of this testing on their IVF outcomes.
Who should consider this trial
Good fit: Ideal candidates are women aged 35 to 41 with infertility issues who are eligible for assisted reproductive technologies.
Not a fit: Patients with recurrent implantation failures or significant uterine abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the chances of live births for older women undergoing IVF.
How similar studies have performed: Previous studies have suggested the potential benefits of chromosomal testing in IVF, but this specific randomized controlled trial approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bondy and 9 other locations
- Hôpital Jean Verdier — Bondy, France (RECRUITING)
- Hôpital Antoine Béclère — Clamart, France (RECRUITING)
- CHU Clermont-Ferrand — Clermont-Ferrand, France (RECRUITING)
- CHU Dijon — Dijon, France (RECRUITING)
- Hôpital Arnaud de Villeneuve — Montpellier, France (RECRUITING)
- CHU Nantes — Nantes, France (RECRUITING)
- Hôpital Cochin — Paris, France (RECRUITING)
- Hopital Tenon — Paris, France (NOT_YET_RECRUITING)
- CHU Strasbourg — Schiltigheim, France (RECRUITING)
- Hôpital Foch — Suresnes, France (RECRUITING)
Study contacts
- Study coordinator: Catherine Patrat, MD, PhD
- Email: catherine.patrat@aphp.fr
- Phone: +33 1 58 41 37 34
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infertility, embryo aneuploidy, Intracytoplasmic Sperm Injection, in vitro fertilization, Next-Generation Sequencing, randomized controlled trial