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


N/A
18 Years
38 Years
Open (Enrolling)
Female
Infertility

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Outcome Measure:

Pregnancy rates

Outcome Description:

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

Outcome Time Frame:

7 weeks

Safety Issue:

No

Principal Investigator

Jacques Kadoch, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

OVO R & D

Authority:

Canada: Health Canada

Study ID:

OVO-12-24

NCT ID:

NCT01886118

Start Date:

March 2013

Completion Date:

August 2016

Related Keywords:

  • Infertility
  • In vitro fertilization
  • Autologous Endometrial Co-Culture
  • Infertility
  • Adenoma

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