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

NCT01762098 | Completed DMC

• 1 other identifier: OVO-12-20
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Infertility; Endometritis; Abortion, Spontaneous

Keywords

In vitro fertilization; Hysteroscopy; Endometrial biopsy

Outcome Measures

Primary Outcomes (1)

• Rate of chronic endometritis

  1 day

Secondary Outcomes (1)

• Pregnancy rate

  1 year

Study Arms (2)

Recurrent miscarriages

Repeated embryo implantation failures

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Population with recurrent miscarriage or repeated embryo implantation failures.

You may qualify if:

• 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.

You may not qualify if:

• Positive pregnancy test
• Unexplained bleeding
• Incomplete miscarriage assessment
• Uterine malformation
• Antibiotic treatment during or within one month prior to the biopsy

Sponsors & Collaborators

• Clinique Ovo: lead

Study Sites (1)

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

Location

Related Publications (1)

• Bouet PE, El Hachem H, Monceau E, Gariepy G, Kadoch IJ, Sylvestre C. Chronic endometritis in women with recurrent pregnancy loss and recurrent implantation failure: prevalence and role of office hysteroscopy and immunohistochemistry in diagnosis. Fertil Steril. 2016 Jan;105(1):106-10. doi: 10.1016/j.fertnstert.2015.09.025. Epub 2015 Oct 9.

  PMID: 26456229 DERIVED

MeSH Terms

Conditions

Infertility; Endometritis; Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Pelvic Inflammatory Disease; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Pregnancy Complications

Study Officials

• Pierre-Emmanuel Bouet, MD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2013
• First Posted: January 7, 2013
• Study Start: November 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: May 1, 2015
• Last Updated: July 27, 2015

Record last verified: 2015-07

Locations

CA (1)