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

NCT ID: NCT01886118

Last Updated: 2015-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-10-31

Brief Summary

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.

Conditions

Infertility

Keywords

In vitro fertilization; Autologous Endometrial Co-Culture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Endometrial biopsy

Intervention Type: PROCEDURE

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

Autologous Endometrial Co-Culture

Intervention Type: OTHER

embryos will be transferred to Endocell co-culture media for Autologous Endometrial Co-Culture between day 2 and day 5

Conventional media culture

Patients in this arm will have their embryos cultured in conventional media

Group Type: ACTIVE_COMPARATOR

Endometrial biopsy

Intervention Type: PROCEDURE

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

Conventional media culture

Intervention Type: OTHER

embryos are cultured in conventional media

Interventions

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

Intervention Type: PROCEDURE

Autologous Endometrial Co-Culture

embryos will be transferred to Endocell co-culture media for Autologous Endometrial Co-Culture between day 2 and day 5

Intervention Type: OTHER

Conventional media culture

embryos are cultured in conventional media

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Genevrier Laboratories

UNKNOWN

Sponsor Role: collaborator

Clinique Ovo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques Kadoch, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Ovo

Locations

Clinique Ovo

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

OVO-12-24

Identifier Type: -

Identifier Source: org_study_id