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

February 3, 2010 updated by: Laboratoires Genévrier

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

720

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Schiltigheim, France, 67303
        • Recruiting
        • CMCO
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires Genévrier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Study Registration Dates

First Submitted

January 27, 2010

First Submitted That Met QC Criteria

January 27, 2010

First Posted (Estimate)

January 28, 2010

Study Record Updates

Last Update Posted (Estimate)

February 4, 2010

Last Update Submitted That Met QC Criteria

February 3, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07F/END01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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