Improvement of Live Babies Rates After ICSI, Using cpFT

Phase 3

Recruiting

Conditions: Infertility

Registration Number: 2024-514350-78-00

Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary: Demonstration of the improvement in the rate of live births after ICSI by supplementing the pre-ICSI incubation medium of oocytes and that of preimplantation embryos with cpFT (1µM) during the 1st embryo transfer in women under 37 years of age.

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing, recruiting

Sex: Not specified

Target Recruitment: 366

Inclusion Criteria

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

Exclusion Criteria

Lack of consent from one or both couple members
Couples requiring IVF or Intra Uterine Insemination treatment.
Early menopause
People who cannot follow protocol survey in France.
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.
ART with gamete or embryo donation.
Participant under guardianship or curatorship

Study & Design

Study Type: INTERVENTIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Live Baby birth rate after the first embryo transfer for women under 37 years of age.		Live Baby birth rate after the first embryo transfer for women under 37 years of age.

Secondary Outcome Measures

Name	Time	Method
1. Number of Metaphase 2 oocyte at decoronization and before ICSI over of the total number of oocytes collected,		1. Number of Metaphase 2 oocyte at decoronization and before ICSI over of the total number of oocytes collected,
2. Blastoformation rate and number of embryo culture failures,		2. Blastoformation rate and number of embryo culture failures,
3. Kinetics of embryonic development analyzed on videos from incubators equipped with recording cameras.		3. Kinetics of embryonic development analyzed on videos from incubators equipped with recording cameras.
4. Blastocysts quality according to Gardner classification,		4. Blastocysts quality according to Gardner classification,
5. Survival rate and blastocysts quality according to Gardner classification after thawing,		5. Survival rate and blastocysts quality according to Gardner classification after thawing,
6. hCG level greater than 1000 over the number of embryos transferred,		6. hCG level greater than 1000 over the number of embryos transferred,
7. Number of pregnancies with cardiac activity on the 12th week ultrasound,		7. Number of pregnancies with cardiac activity on the 12th week ultrasound,
8. Number of miscarriages over the number of pregnancies with positive cardiac activity.		8. Number of miscarriages over the number of pregnancies with positive cardiac activity.
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.		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.
10. Analysis of examinations carried out during pediatric consultations until the child is 1 year old (status-weight curve, Denver and Brunet Lezine scales,)		10. Analysis of examinations carried out during pediatric consultations until the child is 1 year old (status-weight curve, Denver and Brunet Lezine scales,)
11. Weight of the placenta; Study of DNA, RNA, Western-Blot, Methylation, histological study		11. Weight of the placenta; Study of DNA, RNA, Western-Blot, Methylation, histological study

Trial Locations

Locations (6): Assistance Publique Hopitaux De Paris
🇫🇷
Paris, France
Groupe Hospitalier Diaconesses Croix Saint Simon
🇫🇷
Paris, France
Hopital Saint Joseph
🇫🇷
Marseille, France
Maternité Les Bluets
🇫🇷
Paris, France
Centre Hospitalier des 4 villes
🇫🇷
Saint Cloud, France
Clinique de la Muette
🇫🇷
Paris, France
Assistance Publique Hopitaux De Paris
🇫🇷Paris, France
Xavier FERRARETTO
Site contact
33140258884
xavier.ferraretto@aphp.fr
Christophe SIFER
Site contact
33148026247
Christophe.sifer@aphp.fr
Jean-Philippe WOLF
Site contact
33158413731
jean-philippe.wolf@aphp.fr