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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01886118
First Posted: June 25, 2013
Last Update Posted: December 24, 2015
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.
Collaborator:
Genevrier Laboratories
Information provided by (Responsible Party):
OVO R & D
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
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 ]
    Confirmed clinical pregnancy with positive fetal heart on the day of viability ultrasound


Secondary Outcome Measures:
  • Embryo quality [ Time Frame: 5 days ]
    The number of cells and the grade of the embryos will be assess throughout their development.

  • Blastulation rate [ Time Frame: 5 days ]
    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 ]
    Pregnancy rate per patient including all transfer with frozen embryos


Enrollment: 207
Study Start Date: March 2013
Study Completion Date: October 2015
Primary Completion Date: September 2015 (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

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes 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
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): NCT01886118


Locations
Canada, Quebec
Clinique Ovo
Montreal, Quebec, Canada, H4P 2S4
Sponsors and Collaborators
OVO R & D
Genevrier Laboratories
Investigators
Principal Investigator: Jacques Kadoch, MD OVO R & D
  More Information

Responsible Party: OVO R & D
ClinicalTrials.gov Identifier: NCT01886118     History of Changes
Other Study ID Numbers: OVO-12-24
First Submitted: January 3, 2013
First Posted: June 25, 2013
Last Update Posted: December 24, 2015
Last Verified: December 2015

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

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