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

NCT ID: NCT01762098

Last Updated: 2015-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Infertility Endometritis Abortion, Spontaneous

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Recurrent miscarriages

No interventions assigned to this group

Repeated embryo implantation failures

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Clinique Ovo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre-Emmanuel Bouet, MD

Role: PRINCIPAL_INVESTIGATOR

Université de Montréal

Locations

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Clinique Ovo

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 26456229 (View on PubMed)

Other Identifiers

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OVO-12-20

Identifier Type: -

Identifier Source: org_study_id

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