Chronic Endometritis and IVF

NCT02646930 | Completed

• 1 other identifier: Pro00067725
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Endometritis; in Vitro Fertilization

Keywords

chronic endometritis; invitro fertilization; spontaneous abortion

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy rate

  12 weeks gestation

Secondary Outcomes (2)

• Implantation rate

  12 weeks

• Pregnancy loss rate

  12 weeks

Study Arms (1)

Incidence of CE

EXPERIMENTAL

To determine rates of CE in women undergoing initial IVF and outcomes

Procedure: Endometrial biopsy

Interventions

Endometrial biopsy PROCEDURE

Endometrial biopsy in women undergoing first IVF cycle

Incidence of CE

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• University of Illinois at Chicago: collaborator

Study Sites (2)

University of Illinois

Chicago, Illinois, 61820, United States

Location

Duke Fertility Clinic

Durham, North Carolina, 27713, United States

Location

MeSH Terms

Conditions

Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Thomas M Price, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: January 6, 2016
• Study Start: March 3, 2016
• Primary Completion: May 16, 2019
• Study Completion: May 16, 2019
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

US (2)