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Chronic Endometritis in Patients With Recurrent Miscarriages or Repeated Implantation Failures in In-vitro Fertilization

This study is currently recruiting participants.
Verified January 2013 by OVO R & D
Sponsor:
Information provided by (Responsible Party):
OVO R & D
ClinicalTrials.gov Identifier:
NCT01762098
First received: January 3, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

Chronic endometritis is a persistent inflammation of the endometrium. Chronic endometritis is asymptomatic or little symptomatic. Sometimes, patient with chronic endometritis can have genital bleeding, pelvic chronic pain, pain during sexual relations, persistent vaginal white loosing. The hysteroscopy can detect the presence or absence of chronic endometritis.

Some studies showed that the endometritis could have an impact on the embryo implantation and could explain recurrent miscarriages or repeated embryo implantation failures.

The goal of this study is to evaluate the frequency of the chronic endometritis in patients with recurrent miscarriages or repeated embryo implantation failures


Condition
Infertility
Endometritis
Abortion, Spontaneous

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prevalence of Chronic Endometritis in Patients With Recurrent Miscarriages or Repeated Implantation Failures in In-vitro Fertilization

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by OVO R & D:

Primary Outcome Measures:
  • Rate of chronic endometritis [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pregnancy rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Recurrent miscarriages
Repeated embryo implantation failures

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Population with recurrent miscarriage or repeated embryo implantation failures.

Criteria

Inclusion Criteria:

Group repeated miscarriages

  • Women aged 18 to 43 years
  • ≥ 2 miscarriages before 14 weeks of gestation
  • Genetic (karyotype x2), thrombophilic and endocrine assessment should be completed

Group of implantation failure in In-vitro fertilization

  • Women aged 18 to 45 years
  • Absence of pregnancy after 3 good quality embryos transferred in women under 35 years and 4 embryos in the 35 years and over.

Exclusion Criteria:

  • Positive pregnancy test
  • Unexplained bleeding
  • Incomplete miscarriage assessment
  • Uterine malformation
  • Antibiotic treatment during or within one month prior to the biopsy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01762098

Contacts
Contact: Cynthia Lévesque, MSc 514 798-2000 ext 755 c.levesque@cliniqueovo.com
Contact: Michaël Harnois, MSc 514 798-2000 ext 755 m.harnois@cliniqueovo.com

Locations
Canada, Quebec
Clinique Ovo Recruiting
Montreal, Quebec, Canada, H4P 2S4
Contact: Shirley Brugerie, director     514 798-2000 ext 753     s.brugerie@cliniqueovo.com    
Sub-Investigator: Jacques Kadoch, MD            
Principal Investigator: Élise Monceau, MD            
Sponsors and Collaborators
OVO R & D
Investigators
Principal Investigator: Élise Monceau, MD Université de Montréal
  More Information

No publications provided

Responsible Party: OVO R & D
ClinicalTrials.gov Identifier: NCT01762098     History of Changes
Other Study ID Numbers: OVO-12-20
Study First Received: January 3, 2013
Last Updated: January 3, 2013
Health Authority: Canada: Health Canada

Keywords provided by OVO R & D:
In vitro fertilization
Hysteroscopy
Endometrial biopsy

Additional relevant MeSH terms:
Abortion, Spontaneous
Abortion, Habitual
Endometritis
Infertility
Pregnancy Complications
 Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases
Genital Diseases, Male

ClinicalTrials.gov processed this record on May 16, 2013