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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Laboratoires Genévrier.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Laboratoires Genévrier
ClinicalTrials.gov Identifier:
NCT01058603
First received: January 27, 2010
Last updated: February 3, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Infertility
Other: - Conventional culture medium for IVF
Other: - Endocell®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicentre, Randomised, Controlled Clinical Study on the Efficacy in Terms of Clinical Pregnancy Rate of 1 Embryo Transfer at Day 5 After Co-culture on Autologous Endometrial Cells(ENDOCELL®) Versus 1 Embryo Transfer at Day 3 After Culture on Conventional Medium.

Resource links provided by NLM:


Further study details as provided by Laboratoires Genévrier:

Estimated Enrollment: 720
Study Start Date: February 2008
Arms Assigned Interventions
Active Comparator: D3 Other: - Conventional culture medium for IVF
Embryos are cultured on conventional medium and transferred at Day 3. Supernumerary good quality embryos are frozen
Experimental: D5 Other: - Endocell®
Embryos are cultured on ENDOCELL® from Day 2 to Day 5 (Blastocyst stage) One embryo is transferred at Day 5. Supernumerary good quality embryos are frozen.

  Eligibility

Ages Eligible for Study:   18 Years to 36 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058603

Contacts
Contact: Anissa Benoussaidh +33-492914134 abenoussaidh@laboratoires-genevrier.com

Locations
France
CMCO Recruiting
Schiltigheim, France, 67303
Contact: Jeanine Ohl, MD    00 (33)3.88.62.84.34    Jeanin.OHL@sihcus.fr   
Sponsors and Collaborators
Laboratoires Genévrier
  More Information

No publications provided

Responsible Party: Laboratoires Genévrier
ClinicalTrials.gov Identifier: NCT01058603     History of Changes
Other Study ID Numbers: 07F/END01
Study First Received: January 27, 2010
Last Updated: February 3, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Laboratoires Genévrier:
Infertility
Cell Culture
AECC
Endocell
IVF

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 19, 2014