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

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

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Procedure: Endometrial biopsy; Other: Autologous Endometrial Co-Culture; Other: Conventional media culture

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4P 2S4
      • Clinique ovo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy rates	Confirmed clinical pregnancy with positive fetal heart on the day of viability ultrasound	7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Embryo quality	The number of cells and the grade of the embryos will be assess throughout their development.	5 days
Blastulation rate	Percentage of embryos that develops into blastocyst compared to the total number of embryos in culture	5 days
Cumulative pregnancy rate with frozen embryos	Pregnancy rate per patient including all transfer with frozen embryos	5 years

Collaborators and Investigators

• Sponsor: Clinique Ovo
• Collaborators: Genevrier Laboratories

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: January 3, 2013
• First Submitted That Met QC Criteria: June 21, 2013
• First Posted (Estimate): June 25, 2013

Study Record Updates

• Last Update Posted (Estimate): December 24, 2015
• Last Update Submitted That Met QC Criteria: December 23, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: In vitro fertilization; Autologous Endometrial Co-Culture
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: OVO-12-24