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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01058603
Recruitment Status : Unknown
Verified February 2010 by Laboratoires Genévrier.
Recruitment status was:  Recruiting
First Posted : January 28, 2010
Last Update Posted : February 4, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Infertility Other: - Conventional culture medium for IVF Other: - Endocell® Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 36 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Laboratoires Genévrier
ClinicalTrials.gov Identifier: NCT01058603     History of Changes
Other Study ID Numbers: 07F/END01
First Posted: January 28, 2010    Key Record Dates
Last Update Posted: February 4, 2010
Last Verified: February 2010

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

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