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NCT02646930 · ClinicalTrials.gov registry record · NA
Chronic Endometritis and IVF
A NA study of in Vitro Fertilization and Chronic Endometritis, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 57
- Enrollment target
- 2
- Study locations
NCT02646930 is a NA study of in Vitro Fertilization and Chronic Endometritis that has completed, run by Duke University. The registered enrollment target is 57 participants. The trial reports 2 study locations across 2 states.
The verdict
NCT02646930, a NA study of in Vitro Fertilization and Chronic Endometritis, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 57 participants
- Enrollment target
- 2
- Study locations
Study 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
Conditions Studied
Interventions
- PROCEDURE Endometrial biopsy
Study Locations (2)
Illinois
- University of Illinois - Chicago
North Carolina
- Duke Fertility Clinic - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2016-03-03 |
| Est. Completion | 2019-05-16 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02646930
The ClinicalTrials.gov registry entry for NCT02646930 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with in Vitro Fertilization appearing as the primary indexed condition, and to 1 intervention - of which Endometrial biopsy is the first listed.
NCT02646930 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Illinois, North Carolina.
Frequently Asked Questions
What is clinical trial NCT02646930 about?
NCT02646930 is a clinical study titled "Chronic Endometritis and IVF". 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...
What is the current status of trial NCT02646930?
This trial is currently completed. It is a NA study. The enrollment target is 57 participants. The study started on 2016-03-03. Estimated completion is 2019-05-16.
What conditions does trial NCT02646930 study?
This clinical trial studies the following conditions: in Vitro Fertilization, Chronic Endometritis.
What interventions are being tested in trial NCT02646930?
The interventions under investigation include: Endometrial biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT02646930?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02646930 being conducted?
This trial has 2 study locations across Illinois, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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