Chronic Endometritis and IVF (CEIVF)

The Impact of Chronic Endometritis on IVF Pregnancy and Pregnancy Loss Rates

Background: Embryo quality is known to be a very important determinant to predict the implantation and pregnancy rate in IVF patients, however, the role of uterine integrity or endometrial receptivity cannot be overlooked.

Chronic endometritis (CE) is an inflammation of the endometrium diagnosed by the presence of plasma cells in the endometrial stroma. There is not only no census on the definition of CE, the current literature on the impact of CE on reproductive outcome is controversial and consists only of retrospective studies with small sample sizes. Although there is a presumption that CE is related to poor IVF outcome, this belief has not been proven.

Design: Prospective cohort study

Setting: Infertility clinics of 2 academic medical centers

Patients: Patients between the ages of ≥ 21 and ≤ 35 years old undergoing their first IVF cycle will be invited to participate.

Main Outcome Measures: The primary outcome will be ongoing pregnancy after 12 weeks estimated gestational age (EGA) with previously documented fetal cardiac motion. Secondary outcomes will include pregnancy loss rate as defined by chemical pregnancy, blighted ovum or loss of fetal cardiac motion before 12 weeks EGA.

Materials and Methods: The cycle prior to IVF, patients will undergo an in-office endometrial biopsy on cycle days 19-24. Samples will be stained for CD138 and the number of plasma cells will be quantified. The number of plasma cells in a sample that yields the best sensitivity and specificity for pregnancy will be determined by a Receiver-Operator-Curve. This number will then be used as a dichotomous variable to assign categories of "positive for CE" and "negative for CE." Pregnancy and miscarriage rates will then be determined in the positive and negative CE sample with Chi Square Analysis. A secondary sub analysis will be performed to determine pregnancy and miscarriage rates in patients who declined to participate in the study.

Expected Results: The investigators hypothesize that higher rates of CE will be found in women failing to conceive with IVF and with subsequent first-trimester miscarriage.

Study Overview

• Status: Completed
• Conditions: in Vitro Fertilization; Chronic Endometritis
• Intervention / Treatment: Procedure: Endometrial biopsy

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 61820
      • University of Illinois
  • North Carolina
    • Durham, North Carolina, United States, 27713
      • Duke Fertility Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• age of ≥ 21 and ≤ 35 years old
• undergoing first IVF cycle
• a diagnosis of ovulatory dysfunction, pelvic factor, male factor, cervical factor or unexplained infertility

Exclusion Criteria:

• BMI > 40 kg/m2, anti-mullerian hormone (AMH) < 1.0 ng/mL or antral follicle count <10
• previous endometrial ablation
• previous uterine artery embolization
• presence of type 0, 1, 2, 3 fibroid tumor
• presence of type 4 fibroid tumor with a mean diameter of > 4 cm
• presence of uterine anomaly other than arcuate configuration
• presence of an endometrial polyp or endometrial synechiae
• presence of a hydrosalpinx on hysterosalpingography or ultrasound
• positive gonorrhea and chlamydia DNA testing
• Patients on chronic glucocorticoids (except nasal preparations), or using glucocorticoids for assisted hatching will be excluded.
• Patients on monoclonal antibody preparations directed to TNFα will be excluded.
• Post-enrollment exclusion will include patients receiving any antibiotics, except prophylaxis for transvaginal oocyte retrieval (TVOR) or glucocorticoids, except nasal preparations, from the time of endometrial biopsy until initial transvaginal ultrasound (TVUS) for pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Incidence of CE; To determine rates of CE in women undergoing initial IVF and outcomes	Procedure: Endometrial biopsy; Endometrial biopsy in women undergoing first IVF cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ongoing pregnancy rate	12 weeks gestation

Secondary Outcome Measures

Outcome Measure	Time Frame
Implantation rate	12 weeks
Pregnancy loss rate	12 weeks

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: University of Illinois at Chicago
• Investigators: Principal Investigator: Thomas M Price, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2016
• Primary Completion (Actual): May 16, 2019
• Study Completion (Actual): May 16, 2019

Study Registration Dates

• First Submitted: January 4, 2016
• First Submitted That Met QC Criteria: January 4, 2016
• First Posted (Estimate): January 6, 2016

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 12, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: chronic endometritis; invitro fertilization; spontaneous abortion
• Additional Relevant MeSH Terms: Uterine Diseases; Adnexal Diseases; Pelvic Inflammatory Disease; Endometritis
• Other Study ID Numbers: Pro00067725

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No