Evaluate the Interest of the Pre-conceptional Endometrial Immune Profiling to Increase Birth Rates

• Register: ClinicalTrials.gov
• Last refreshed on: 12 February 2024
• Main ID: NCT02262117
• Date of registration: 07/10/2014
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Evaluate the Interest of the Pre-conceptional Endometrial Immune Profiling to Increase Birth Rates PRECONCEPTIO
• Scientific title: A Prospective, Randomized, Controlled, Two-arm Study to Evaluate the Interest of the Pre-conceptional Endometrial Immune Profiling to Increase Birth Rates Through a Care Personalization in Reproductive Medicine Before IVF
• Date of first enrolment: February 20, 2015
• Target sample size: 400
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02262117
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Nathalie LEDEE, MD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion criteria

Inclusion Criteria:

- Infertile patients will be included at the beginning of their medical care in
reproduction once the indication to perform either an IVF with or without ICSI has
been established. The indication for IVF will be: tubal infertility, endometriosis,
ovarian dysovulation with failure of intra-uterine insemination, idiopathic
infertility The indication for ICSI will be: male infertility
(oligo-astheno-teratospermia), previous failure of oocytes fertilization in IVF

- Patients should be younger than 38 years old (Age < 38)

- with a normal ovarian reserve (AMH>1.5ng/ml, FSH<10 IU/l on day-3, antral
follicles count (AFC) over 6 on day-3 of the cycle by ultrasound)

- The range of the IVF or ICSI attempt should be lower than 3 or equal at 2 (first
or second IVF/ICSI). If a live birth occurred in the past by IVF/ICSI, the range
of the new attempt is 1.

- With a signed informed and consent form

- With medical insurance

Exclusion Criteria:

- Azoospermia or cryptozoospermia (Patient's partner)

- IVF/ICSI attempt scheduled in another ART unit

- Contraindication to any experimental treatment (Cortancyl, Intralipids, Human
Chorionic Gonadotropin)

- Maternal serology positive for hepatite C or B



Age minimum: 18 Years
Age maximum: 38 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Reproductive Medicine

Intervention(s)

Other: standard care

Drug: specific treatment

Primary Outcome(s)

Live birth rate (without congenital abnormality or malformation)/transfer following the first (fresh) embryo transfer after uterine immune analysis [Time Frame: up to 18 months]

Secondary Outcome(s)

Number of early miscarriage in the first trimester [Time Frame: 12 amenorrhea weeks]

Number of prematurity (A birth below 37 weeks of amenorrhea defines the premature birth and before 28 weeks of amenorrhea the severe preterm birth) (for babies without congenital anormality or malformation) [Time Frame: between 28 and 37 amenorrhea weeks]

Pregnancy rate/transfer following the first embryo transfer [Time Frame: 8 amenorrhea weeks]

Number of embryo implanted/number of embryos replaced) [Time Frame: at 8, 12 and 40 amenorrhea weeks]

Number of pre-eclampsia (defined as the association of hypertension over 14/9 mm of hg with proteinuria occuring during the pregnancy- this pathology is related to insufiscient invasion during the first trimester) [Time Frame: up to 18 months]

Number of late miscarriage [Time Frame: between 13 and 24 amenorrhea weeks]

Ongoing pregnancy rate/transfer following the first embryo transfer at 12 weeks of amenorrhea [Time Frame: 12 amenorrhea weeks]

Term of birth (for babies without congenital anormality or malformation) [Time Frame: up to 18 months]

Weight at birth [Time Frame: up to 18 months]

Investigate if immunologic events studying on endometrial level have an impact on blood level or are independent. [Time Frame: up to 15 months]

Number of pathologic pregnancy included stillbirth and congenital abnormality [Time Frame: up to 18 months]

Number of physiological pregnancies after personalization [Time Frame: up to 18 months]

Secondary ID(s)

P130929

Source(s) of Monetary Support

Please refer to primary and secondary sponsors