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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01762098
• Other study ID #: OVO-12-20
• Status: Completed
• Phase: N/A
• First received: January 3, 2013
• Last updated: July 24, 2015
• Start date: November 2012
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: OVO R & D
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Endometritis
• Infertility

Locations

Country	Name	City	State
Canada	Clinique Ovo	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
OVO R & D

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of chronic endometritis		1 day	No
Secondary	Pregnancy rate		1 year	No