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

Last updated: February 3, 2010
Sponsor: Laboratoires Genévrier
Overall Status: Trial Status Unknown

Phase

3

Condition

Infertility

Treatment

N/A

Clinical Study ID

NCT01058603
07F/END01
  • Ages 18-36
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women aged ≥ 18 and ≤ 36

  • Undergoing ovarian stimulation for an In Vitro Fertilization (IVF) or IntraCytoplasmic 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

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, uncontrolledprolactinaemia, 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

Total Participants: 720
Study Start date:
February 01, 2008
Estimated Completion Date:

Connect with a study center

  • CMCO

    Schiltigheim, 67303
    France

    Active - Recruiting

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