Chronic EndometritisCEIVFNCT02646930
Chronic Endometritis and IVF
A study testing Endometrial biopsy in people with Chronic Endometritis and in Vitro Fertilization, run by Duke University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 35 years, women only
- Conditions the study is for
- Chronic Endometritis, in Vitro Fertilization
- What is being tested?
- Endometrial biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Mar 2016to 16 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Illinois
Chicago, Illinois, 61820
Duke Fertility Clinic
Durham, North Carolina, 27713
About this study
Official title: 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.
Read more
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
- Being tested
- Endometrial biopsy
- Keywords
- chronic endometritis, invitro fertilization, spontaneous abortion
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial biopsyProcedure or surgery
Endometrial biopsy in women undergoing first IVF cycle
| Study group | Role | What they receive |
|---|---|---|
| Incidence of CE | Experimental | To determine rates of CE in women undergoing initial IVF and outcomes Receives: Procedure: Endometrial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Measured: 12 weeks gestation
Secondary outcomes (2)
Implantation rate
Measured: 12 weeks
Pregnancy loss rate
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study start3 Mar 2016
- Primary completion16 May 2019
- Study completion16 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic EndometritisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois at Chicago
- Responsible party
- Sponsor
- Investigators
- Thomas M Price, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646930
- Sponsor's protocol ID
- Pro00067725
- Acronym
- CEIVF
- Status last verified
- Oct 2020
- First submitted
- 4 Jan 2016
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Chronic Endometritis on IVF Pregnancy and Pregnancy Loss Rates
- ClinicalTrials.gov ID
- NCT02646930
- Acronym / sponsor ID
- CEIVF / Pro00067725
- Conditions
- Chronic Endometritis, in Vitro Fertilization
- Keywords
- chronic endometritis, invitro fertilization, spontaneous abortion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of Illinois at Chicago
- Study start
- 3 Mar 2016 (actual)
- Primary completion
- 16 May 2019 (actual)
- Study completion
- 16 May 2019 (actual)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Incidence of CE | Experimental | Procedure: Endometrial biopsyTo determine rates of CE in women undergoing initial IVF and outcomes |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endometrial biopsyEndometrial biopsy in women undergoing first IVF cycle | Procedure or surgery | Incidence of CE |
Primary outcome
Ongoing pregnancy rate
Time frame: 12 weeks gestation
2 secondary outcomes
Implantation rate
Time frame: 12 weeks
Pregnancy loss rate
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas M Price, MD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endometrial biopsy in people with Chronic Endometritis and in Vitro Fertilization, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rate (time frame: 12 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.