Clinical trial NCT01886118: A Trial Evaluating Autologous Endometrial Co-Culture Versus Conventional Medium in the Treatment of Infertility
Official title: A Randomized Trial Evaluating Autologous Endometrial Co-Culture Versus Conventional Medium in the Treatment of Infertility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: In vitro fertilization
Autologous Endometrial Co-Culture
Lead sponsor: Clinique Ovo
Sponsor class: INDUSTRY
Collaborators: name: Genevrier Laboratories
First posted: 2013-06-25
Enrollment: 207
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pregnancy rates
timeFrame: 7 weeks
Secondary outcomes:
measure: Embryo quality
timeFrame: 5 days
measure: Blastulation rate
timeFrame: 5 days
measure: Cumulative pregnancy rate with frozen embryos
timeFrame: 5 years
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Clinique Ovo
state: Quebec
Study officials:
affiliation: Clinique Ovo
name: Jacques Kadoch, MD
role: PRINCIPAL_INVESTIGATOR
References: