Improvement of Live Babies Rates After ICSI, Using cpFT

2024-514350-78-00 Protocol P170706J Therapeutic confirmatory (Phase III) Ongoing, recruitment ended

Start 29 Jul 2021 · Status Ongoing, recruitment ended · 1 EU/EEA countries · 8 sites · Protocol P170706J

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruitment ended
Participants planned 366
Countries 1
Sites 8

Infertility

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.

Key facts

Sponsor
Assistance Publique Hopitaux De Paris
Participant type
Patients
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
Trial duration
29 Jul 2021 → ongoing
Decision date (initial)
2024-10-28
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
SATT Ile de France

External identifiers

EU CT number
2024-514350-78-00
EudraCT number
2020-004214-35
ClinicalTrials.gov
NCT05559398

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

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.

Secondary objectives 11

  1. 1- Level of Metaphase II oocytes
  2. 2- Quality of the embryonic culture
  3. 3- Evaluation of the kinetics of embryonic development when possible.
  4. 5- Quality of the embryos after vitrification
  5. 6- Implantation rate with positive Beta hCG after transfer
  6. 7- Clinical pregnancy rates with cardiac activity
  7. 8- The rate of miscarriages per pregnancy
  8. 4. Evaluation of the embryo quality at the blastocyst stage
  9. 9. Evaluation the health of the baby during pregnancy and at birth
  10. 10. Assessment of the baby health and development at one year old
  11. 11. Evaluation of the placental weight and epigenetic markers when delivery in Cochin only

Conditions and MedDRA coding

Infertility

VersionLevelCodeTermSystem organ class
21.0 PT 10021926 Infertility 100000004872

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 Improvement of birth rates after ICSI, using cpFT
The oocytes and embryos of patients in the Control group will be incubated in the CSCM-C culture medium (Irvine): Control group. - Oocytes and embryos of patients in the cpFT group will be incubated in the same CSCM-C culture medium, but supplemented with 1M cpFT
 Randomised Controlled Double [{"id":139177,"code":2,"name":"Investigator"},{"id":139178,"code":5,"name":"Carer"},{"id":139179,"code":1,"name":"Subject"}] Control group: The oocytes and embryos of patients in the Control group will be incubated in the CSCM-C culture medium (Irvine): Control group.
cpFT group: Oocytes and embryos of patients in the cpFT group will be incubated in the same CSCM-C culture medium, but supplemented with 1M cpFT during the pre-ICSI oocyte incubation and during the preimplantation development of the embryos: cpFT group

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

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

Exclusion criteria 7

  1. - Lack of consent from one or both couple members
  2. - Couples requiring IVF or Intra Uterine Insemination treatment.
  3. - Early menopause
  4. - People who cannot follow protocol survey in France.
  5. - 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.
  6. - ART with gamete or embryo donation.
  7. - Participant under guardianship or curatorship

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 11

  1. 1. Number of Metaphase 2 oocyte at decoronization and before ICSI over of the total number of oocytes collected,
  2. 2. Blastoformation rate and number of embryo culture failures,
  3. 3. Kinetics of embryonic development analyzed on videos from incubators equipped with recording cameras.
  4. 4. Blastocysts quality according to Gardner classification,
  5. 5. Survival rate and blastocysts quality according to Gardner classification after thawing,
  6. 6. hCG level greater than 1000 over the number of embryos transferred,
  7. 7. Number of pregnancies with cardiac activity on the 12th week ultrasound,
  8. 8. Number of miscarriages over the number of pregnancies with positive cardiac activity.
  9. 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. 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. 11. Weight of the placenta; Study of DNA, RNA, Western-Blot, Methylation, histological study

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

cpFT

PRD11630156 · Product

Active substance
Cpft Trifluoroacetate
Pharmaceutical form
SOLUTION
Route of administration
ROUTE OF ADMINISTRATION NOT APPLICABLE
Max daily dose
1 nmol/ml nanomole(s)/millilitre
Max total dose
1 nmol/ml nanomole(s)/millilitre
Max treatment duration
6 Day(s)
Authorisation status
Not Authorised
MA holder
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
Paediatric formulation
No
Orphan designation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

251 Total trials 131 Recruiting 54 Ended
Academic / Non-commercial
Sponsor organisation
Assistance Publique Hopitaux De Paris
Address
Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux
City
Paris Cedex 10
Postcode
75475
Country
France

Scientific contact point

Organisation
Assistance Publique Hopitaux De Paris
Contact name
Jean-Philippe WOLF

Public contact point

Organisation
Assistance Publique Hopitaux De Paris
Contact name
Jean-Philippe WOLF

Locations

1 EU/EEA country · 8 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Ongoing, recruitment ended 366 8
Rest of world — 0 —

Investigational sites

France

8 sites · Ongoing, recruitment ended
Groupe Hospitalier Diaconesses Croix Saint Simon
Laboratoire de Biologie de la reproduction, 12 Rue Du Sergent Bauchat, 75012, Paris
Maternité Les Bluets
Laboratoire d'AMP, 4 rue Lasson, 75012, Paris
Assistance Publique Hopitaux De Paris
Biologie de la reproduction, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Assistance Publique Hopitaux De Paris
Biologie de la reproduction, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Centre Hospitalier des 4 villes
Laboratoire d'AMP, rue Lauer, 92210, Saint Cloud
Hopital Saint Joseph
Médecine biologique, 26 Boulevard De Louvain, 13008, Marseille
Clinique de la Muette
Biologie de la reproduction, 46-48 rue Nicolo, 75016, Paris
Assistance Publique Hopitaux De Paris
Histologie-Embrylogie-Cytogénétique, Avenue Du 14 Juillet, 93140, Bondy

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
France 2021-07-29 2021-07-29 2025-07-23

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol_2024-514350-78-00 6.0
Protocol (for publication) D4_Patient facing documents 1
Recruitment arrangements (for publication) K1_Recruitment arrangements_20250610 1
Subject information and informed consent form (for publication) L1_SIS-ICF-adult 5-0
Synopsis of the protocol (for publication) D1_Protocol synopsis_2024-514350-78-00 6.1

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-10-02 France Acceptable
2024-10-25
 2024-10-28
2 SUBSTANTIAL MODIFICATION SM-1 2025-06-23 France Acceptable
2025-08-14
 2025-08-14

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