A Trial Evaluating Autologous Endometrial Co-Culture Versus Conventional Medium in the Treatment of Infertility (OvoGEN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by OVO R & D
Sponsor:
Collaborator:
Genevrier Laboratories
Information provided by (Responsible Party):
OVO R & D
ClinicalTrials.gov Identifier:
NCT01886118
First received: January 3, 2013
Last updated: May 26, 2014
Last verified: May 2014
  Purpose

One of the main factors in the success of in-vitro fertilization is the quality of the environment of the embryo. In contrast to maternal age, the environment in which the embryo develops is a modifiable factor. Many techniques, such as assisted hatching and perfecting culture media have been attempted in order to reproduce as much as possible the natural, physiological environment of the mother for the embryo in in-vitro fertilization. However, the different new culture media used are devoid of growth factors normally secreted by uterine cells that enhance the interaction between the embryo and its environment.

Because the endometrial lining of the uterus secretes many different cytokines necessary for growth of the embryo, a new procedure has been developed to mimic the natural environment of the growing embryo using autologous (patient's own) endometrial cells in co-culture with the embryo. Endocell, a product developed by Genévrier Laboratories, received commercial authorization in France in 2011. It is the only system of autologous embryo-endometrium co-culture available on the actual market. The process consists of developing the embryo on a monolayer of the patient's own endometrial cells in order to favor its growth until the blastocyst stage (day 5) and to improve its implantation.


Condition Intervention
Infertility
Procedure: Endometrial biopsy
Other: Autologous Endometrial Co-Culture
Other: Conventional media culture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: A Randomized Trial Evaluating Autologous Endometrial Co-Culture Versus Conventional Medium in the Treatment of Infertility

Resource links provided by NLM:


Further study details as provided by OVO R & D:

Primary Outcome Measures:
  • Pregnancy rates [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    Confirmed clinical pregnancy with positive fetal heart on the day of viability ultrasound


Secondary Outcome Measures:
  • Embryo quality [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    The number of cells and the grade of the embryos will be assess throughout their development.

  • Blastulation rate [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Percentage of embryos that develops into blastocyst compared to the total number of embryos in culture

  • Cumulative pregnancy rate with frozen embryos [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Pregnancy rate per patient including all transfer with frozen embryos


Estimated Enrollment: 1080
Study Start Date: March 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous Endometrial Co-Culture
The embryos will be transferred to Endocell co-culture media for Autologous Endometrial Co-Culture between day 2 and day 5.
Procedure: Endometrial biopsy
A luteal phase endometrial biopsy will be performed in the cycle prior to the patient's In Vitro Fertilization stimulation cycle using a standard Pipelle Endometrial Suction curette in all participants between days ovulation+5 and ovulation+7 of the cycle preceding the stimulation cycle
Other: Autologous Endometrial Co-Culture
embryos will be transferred to Endocell co-culture media for Autologous Endometrial Co-Culture between day 2 and day 5
Active Comparator: Conventional media culture
Patients in this arm will have their embryos cultured in conventional media
Procedure: Endometrial biopsy
A luteal phase endometrial biopsy will be performed in the cycle prior to the patient's In Vitro Fertilization stimulation cycle using a standard Pipelle Endometrial Suction curette in all participants between days ovulation+5 and ovulation+7 of the cycle preceding the stimulation cycle
Other: Conventional media culture
embryos are cultured in conventional media

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing In Vitro Fertilization (IVF) or IVF/Intra Cytoplasmic Sperm Injection (ICSI) at OVO clinic
  • Having a prescription of a long, short or an antagonist IVF protocols using both urinary and synthetic gonadotropins
  • Having a single embryo transfer
  • Regular menstrual cycles
  • Basal follicle stimulating hormone levels less than 10 IU/l within 6 months prior to entering the study
  • anti-mullerian hormone more than 1 ng/ml measured within a year
  • Normal sonohysterogram or hysteroscopy done within the last 2 years
  • Previously undergone a maximum of 3 IVF cycles
  • Documented negative serology tests within 1 year prior recruitment for: Hepatitis B, Syphilis, HIV based on Health Canada recommendations for treatment in an IVF laboratory.

Exclusion Criteria:

  • Amenorrhea
  • Anovulatory cycles
  • Polycystic Ovarian syndrome
  • Chronic endometritis
  • Severe endometriosis
  • Hydrosalpinx
  • Uterine synechia or Asherman's syndrome
  • Submucosal uterine fibroids or intra-cavitary polyps greater than 1cm
  • Uterine anomalies
  • Use of anticoagulants
  • Secretory Azoospermia
  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: NCT01886118

Contacts
Contact: Cynthia Lévesque, MSc 514 798-2000 ext 755 c.levesque@cliniqueovo.com
Contact: Sandra Bisotto, MSc 514 798-2000 ext 755 s.bisotto@cliniqueovo.com

Locations
Canada, Quebec
Clinique Ovo Recruiting
Montreal, Quebec, Canada, H4P 2S4
Contact: Shirley Brugerie, director    514 798-2000 ext 753    s.brugerie@cliniqueovo.com   
Contact: Michael Harnois, Research assistant    514-798-2000 ext 755    m.harnois@cliniqueovo.com   
Principal Investigator: Jacques Kadoch, MD         
Sponsors and Collaborators
OVO R & D
Genevrier Laboratories
Investigators
Principal Investigator: Jacques Kadoch, MD OVO R & D
  More Information

No publications provided

Responsible Party: OVO R & D
ClinicalTrials.gov Identifier: NCT01886118     History of Changes
Other Study ID Numbers: OVO-12-24
Study First Received: January 3, 2013
Last Updated: May 26, 2014
Health Authority: Canada: Health Canada

Keywords provided by OVO R & D:
In vitro fertilization
Autologous Endometrial Co-Culture

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

ClinicalTrials.gov processed this record on September 18, 2014