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Completed

NCT Number: NCT01886118

A 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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

Conventional media culture

Other

embryos are cultured in conventional media

Primary outcomes

  1. Pregnancy rates

    Time frame: 7 weeks

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

Secondary outcomes

  1. Embryo quality

    Time frame: 5 days

    The number of cells and the grade of the embryos will be assess throughout their development.

  2. Blastulation rate

    Time frame: 5 days

    Percentage of embryos that develops into blastocyst compared to the total number of embryos in culture

  3. Cumulative pregnancy rate with frozen embryos

    Time frame: 5 years

    Pregnancy rate per patient including all transfer with frozen embryos

Sponsors and collaborators

Lead sponsor

Clinique Ovo

Industry

Collaborators

  • Genevrier Laboratories

Registry information

Official study title

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

Acronym: OvoGEN

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 25, 2013
Registry last updated
Dec 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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