Endometrial ReceptivityNCT03843034
Endometrial Markers in Autoimmune Diseases
An observational study of Endometrial Receptivity and Fertility, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Autoimmune diseases cause a decreased endometrial receptivity during the implantation window, most likely changing the endometrial cytokines pattern due to dysregulation of the inflammatory processes.Therefore, endometrial cytokine profiles will be compared in women with autoimmune disease and normal, fertile women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometrial Receptivity, Fertility, Autoimmune Diseases
- What is being tested?
- Measure endometrial markers
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Feb 2019to 31 Dec 2023
- Phase
- Observational
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with thyroid diseases, rheumatoid arthritis, inflammatory bowel diseases, multiple sclerosis, diabetes mellitus, and psoriasis will be included in the study Group (Age: 20-40 years old). Healthy women receiving assisted reproduction due to male infertility will be included in the control Group (Age: 20-40 years old).
Who may be able to join
- Study group:
- Females with infertility combined with autoimmune disease and in fertility treatment.
- Control group:
- Female from couples with severe male infertility and in fertility treatment.
Who cannot join
- Language problems to such an extent that the subjects do not understand the scope of the study.
- Abnormal follicle stimulating hormone (FSH),
- Abnormal antral follicles Count
- Genital infections
- Endometriosis
- Tubal occlusion
- Polycystic ovarian syndrome
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital
Odense, DK-5000
About this study
Official title: Endometrial Markers in Women With Autoimmune Diseases Receiving Assisted Reproduction
Autoimmune diseases cause a decreased endometrial receptivity during the implantation window, most likely changing the endometrial cytokines pattern due to dysregulation of the inflammatory processes.Therefore, endometrial cytokine profiles will be compared in women with autoimmune disease and normal, fertile women.
The collected endometrial tissue and blood samples will be examined for the cytokines profiling using commercially available ELISA kits.
The sample size was calculated choosing, as primary outcome, changes in endometrial LIF concentration between the disease and control Group, which is our main goal. Given a type I error of 5%, a maximum of 21 women are needed for each Group to reach the desired power of 80% to detect the least changes in concentrations.
- Conditions
- Endometrial Receptivity, Fertility, Autoimmune Diseases
- Being tested
- Measure endometrial markers
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure endometrial markersGenetic
Endometrial biopsies will be taken from participants in both groups
| Study group | Role | What they receive |
|---|---|---|
| Study group | Infertile women with autoimmune disease Receives: Genetic: Measure endometrial markers | |
| Control group | Women from couples with severe male infertility Receives: Genetic: Measure endometrial markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial cytokine LIF concentration (pg/ml)
The endometrial cytokine LIF profile in endometrial biopsies of women with autoimmune disease will be determined and compared to normal, fertile women (pg/mL)
Measured: February 18, 2019 - August 31, 2020
Secondary outcomes (2)
Blood concentration of cytokines such as LIF, IL6, TNFα TGFα (pg/ml)
The blood cytokines concentration will be compared between the autoimmune diseases group and the control group. Moreover the cytokines concentration in blood and endometrial tissue will be compared.
Measured: February 18, 2019 - August 2020
endometrial concentration of cytokines such as, IL6, TNFα TGFα (pg/ml)
The endometrial cytokines concentration will be compared between the autoimmune diseases group and the control group. Moreover the cytokines concentration in blood and endometrial tissue will be compared.
Measured: February 18, 2019 - August 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start18 Feb 2019
- Primary completion31 Jan 2023
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial ReceptivityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Fedder, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843034
- Sponsor's protocol ID
- Lab.Reprod.Biol. - Odense.04
- Status last verified
- Nov 2023
- First submitted
- 11 Feb 2019
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Markers in Women With Autoimmune Diseases Receiving Assisted Reproduction
- ClinicalTrials.gov ID
- NCT03843034
- Acronym / sponsor ID
- Lab.Reprod.Biol. - Odense.04
- Conditions
- Endometrial Receptivity, Fertility, Autoimmune Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Feb 2019 (actual)
- 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.
Autoimmune diseases cause a decreased endometrial receptivity during the implantation window, most likely changing the endometrial cytokines pattern due to dysregulation of the inflammatory processes.Therefore, endometrial cytokine profiles will be compared in women with autoimmune disease and normal, fertile women.
The collected endometrial tissue and blood samples will be examined for the cytokines profiling using commercially available ELISA kits.
The sample size was calculated choosing, as primary outcome, changes in endometrial LIF concentration between the disease and control Group, which is our main goal. Given a type I error of 5%, a maximum of 21 women are needed for each Group to reach the desired power of 80% to detect the least changes in concentrations.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Genetic: Measure endometrial markersInfertile women with autoimmune disease |
| Control group | – | Genetic: Measure endometrial markersWomen from couples with severe male infertility |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with thyroid diseases, rheumatoid arthritis, inflammatory bowel diseases, multiple sclerosis, diabetes mellitus, and psoriasis will be included in the study Group (Age: 20-40 years old). Healthy women receiving assisted reproduction due to male infertility will be included in the control Group (Age: 20-40 years old).
Key inclusion criteria (4 listed)
- Females with infertility combined with autoimmune disease and in fertility treatment.
- Female from couples with severe male infertility and in fertility treatment.
Key exclusion criteria (7 listed)
- Language problems to such an extent that the subjects do not understand the scope of the study.
- Abnormal follicle stimulating hormone (FSH),
- Abnormal antral follicles Count
- Genital infections
- Endometriosis
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 |
|---|---|---|
| Measure endometrial markersEndometrial biopsies will be taken from participants in both groups | Genetic | Control group, Study group |
Primary outcome
Endometrial cytokine LIF concentration (pg/ml)
Time frame: February 18, 2019 - August 31, 2020
The endometrial cytokine LIF profile in endometrial biopsies of women with autoimmune disease will be determined and compared to normal, fertile women (pg/mL)
2 secondary outcomes
Blood concentration of cytokines such as LIF, IL6, TNFα TGFα (pg/ml)
Time frame: February 18, 2019 - August 2020
endometrial concentration of cytokines such as, IL6, TNFα TGFα (pg/ml)
Time frame: February 18, 2019 - August 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Receptivity and Fertility, run by Odense University Hospital at 1 site in Denmark.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Results are not available in the source record.
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?
Endometrial cytokine LIF concentration (pg/ml) (time frame: February 18, 2019 - August 31, 2020). 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 2 Nov 2023.