Efficacy of Endocell® vs Conventional Medium in the Treatment of Infertility

Laboratoires Genévrier

Status and phase

Unknown

Phase 3

Conditions

Infertility

Treatments

Other: - Endocell®

Other: - Conventional culture medium for IVF

Study type

Interventional

Funder types

Industry

Identifiers

NCT01058603

07F/END01

Details and patient eligibility

About

The aim of this study is to demonstrate the efficacy of a single embryo transfer at blastocyst stage (Day 5) after co-culture on Autologous Endometrial Cell Culture (AECC) versus transfer of a single embryo at Day 3 after culture in conventional medium. Efficacy will be assessed in terms of clinical pregnancy rate 5 to 8 weeks after embryo transfer.

Enrollment

720 estimated patients

Sex

Female

Ages

18 to 36 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Women aged ≥ 18 and ≤ 36
Undergoing ovarian stimulation for an In Vitro Fertilization (IVF) or Intra Cytoplasmic Sperm Injection (ICSI)
Having experienced no more than 1 Embryo Transfer failure
With basal FSH level ≤ 12 IU/l within the 6 months prior to the study
Endometrial biopsy during the menstrual cycle preceding the ovarian stimulation (6 to 12 days after a documented ovulation)
Negative serology for HIV 1 and 2, hepatitis B and C, HTLV 1 and 2, syphilis

Exclusion criteria

Hypersensitivity to one of the culture media components
Oocyte donation, sperm donation
Thawed embryos transfer
Women with endometriosis grade III and IV, chronic endometritis, hydrosalpinx, polycystic ovary, amenorrhoea, anovulation, uterus with malformation, uncontrolled prolactinaemia, uterine synechia, uterine fibroma, women exposed to distilbene, uterine polyps
Women affected by pathologies associated with any contraindication of being pregnant
Abnormal gynaecologic bleeding of undetermined origin
Uncontrolled thyroid (TSH dosage) or adrenal dysfunction
Neoplasias, any pathologies of the endometrium or the cervix