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

Phase 3

• Conditions: Infertility
• Interventions: Other: - Conventional culture medium for IVF; Other: - Endocell®

• Registration Number: NCT01058603
• Lead Sponsor: Laboratoires Genévrier

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2010-01-27
• Study First Submitted QC: 2010-01-27
• Study First Posted: 2010-01-28
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-03
• Last Update Posted: 2010-02-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 720

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D3	- Conventional culture medium for IVF	-
D5	- Endocell®	-

Trial Locations

Locations (1)

CMCO; 🇫🇷 Schiltigheim, France