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

NCT01886118 | Completed DMC

• 1 other identifier: OVO-12-24
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pregnancy rates

  Confirmed clinical pregnancy with positive fetal heart on the day of viability ultrasound

  7 weeks

Secondary Outcomes (3)

• Embryo quality

  5 days

• Blastulation rate

  5 days

• Cumulative pregnancy rate with frozen embryos

  5 years

Study Arms (2)

Autologous Endometrial Co-Culture

EXPERIMENTAL

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

Procedure: Endometrial biopsy; Other: Autologous Endometrial Co-Culture

Conventional media culture

ACTIVE COMPARATOR

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

Procedure: Endometrial biopsy; Other: Conventional media culture

Interventions

Endometrial biopsy 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; Conventional media culture

Autologous Endometrial Co-Culture OTHER

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

Autologous Endometrial Co-Culture

Conventional media culture OTHER

embryos are cultured in conventional media

Conventional media culture

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Ovo: lead
• Genevrier Laboratories: collaborator

Study Sites (1)

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Jacques Kadoch, MD

  Clinique Ovo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2013
• First Posted: June 25, 2013
• Study Start: March 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 24, 2015

Record last verified: 2015-12

Locations

CA (1)