CPFT TRIFLUOROACETATE for Infertility

Inclusion criteria

• {"criterion_text":"- Couples requiring Medically Assisted Reproduction (AMP)."}
• {"criterion_text":"- Couples eligible for ICSI"}
• {"criterion_text":"- Women 18 to 36 years old inclusive."}
• {"criterion_text":"- Men 18 to 58 years old inclusive"}
• {"criterion_text":"- Use of CSCM-C culture medium from Biocare/Irvine, exclusively."}
• {"criterion_text":"- People affiliated to a Social Security system"}

Exclusion criteria

• {"criterion_text":"- Lack of consent from one or both couple members"}
• {"criterion_text":"- Couples requiring IVF or Intra Uterine Insemination treatment."}
• {"criterion_text":"- Early menopause"}
• {"criterion_text":"- People who cannot follow protocol survey in France."}
• {"criterion_text":"- Women with a contra-indication to ART treatment or an associated pathology such as: hypertension, risk of eclampsia, family genetic problems, diabetes, uterine septations, synechiae adhesions, adenomyosis or any other contra-indication judged as such by the investigator."}
• {"criterion_text":"- ART with gamete or embryo donation."}
• {"criterion_text":"- Participant under guardianship or curatorship"}

Primary endpoints

• {"endpoint_text":"- Live Baby birth rate after the first embryo transfer for women under 37 years of age.","definition_or_measurement_approach":"Rate/proportion of women <37 years achieving a live birth after the first embryo transfer."}

Secondary endpoints

• {"endpoint_text":"- 1. Number of Metaphase 2 oocyte at decoronization and before ICSI over of the total number of oocytes collected,","definition_or_measurement_approach":"Proportion/count of Metaphase II oocytes at decoronization and before ICSI relative to total oocytes collected."}
• {"endpoint_text":"- 2. Blastoformation rate and number of embryo culture failures,","definition_or_measurement_approach":"Blastoformation rate (proportion of embryos reaching blastocyst) and count of culture failures."}
• {"endpoint_text":"- 3. Kinetics of embryonic development analyzed on videos from incubators equipped with recording cameras.","definition_or_measurement_approach":"Assessment of embryonic development timing/kinetics using time-lapse video recordings from incubators with cameras."}
• {"endpoint_text":"- 4. Blastocysts quality according to Gardner classification,","definition_or_measurement_approach":"Blastocyst quality graded using the Gardner classification system."}
• {"endpoint_text":"- 5. Survival rate and blastocysts quality according to Gardner classification after thawing,","definition_or_measurement_approach":"Post-thaw survival rate of blastocysts and Gardner classification of blastocyst quality after thawing."}
• {"endpoint_text":"- 6. hCG level greater than 1000 over the number of embryos transferred,","definition_or_measurement_approach":"Number/proportion of transfers with β-hCG level >1000 relative to number of embryos transferred."}
• {"endpoint_text":"- 7. Number of pregnancies with cardiac activity on the 12th week ultrasound,","definition_or_measurement_approach":"Count of pregnancies demonstrating fetal cardiac activity on 12-week ultrasound."}
• {"endpoint_text":"- 8. Number of miscarriages over the number of pregnancies with positive cardiac activity.","definition_or_measurement_approach":"Number/proportion of miscarriages among pregnancies that had positive cardiac activity."}
• {"endpoint_text":"- 9. Pregnancy and ectopic pregnancy rates. Rate of pregnancy therapeutic termination and rate of anomaly on morphological ultrasounds at 6 months and malformation at birth. Record of the term of delivery, weight, height and head circumference of the baby at birth.","definition_or_measurement_approach":"Rates of pregnancy, ectopic pregnancy, therapeutic termination; rates of anomalies on 6-month ultrasounds and malformations at birth; collection of delivery term and newborn anthropometrics at birth."}
• {"endpoint_text":"- 10. Analysis of examinations carried out during pediatric consultations until the child is 1 year old (status-weight curve, Denver and Brunet Lezine scales,)","definition_or_measurement_approach":"Pediatric assessments up to age 1 year including growth charts and developmental assessments (Denver and Brunet Lezine scales)."}
• {"endpoint_text":"- 11. Weight of the placenta; Study of DNA, RNA, Western-Blot, Methylation, histological study","definition_or_measurement_approach":"Collection of placental weight and molecular/histological analyses (DNA, RNA, Western blot, methylation, histology) for deliveries at specified center (Cochin)."}

France

Earliest CTIS Part Ii Submission Date

21-06-2024

Latest Decision Or Authorization Date

14-08-2025

Processing Time Days

419

Number Of Sites

8

Number Of Participants

366

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"SATT Ile de France","duties_or_roles":"Source of monetary support","organisation_type":""}