InfertilityNCT02219425
Gene Expression Analysis of the Endometrium After Endometrial Biopsy in Fertile Women
A study testing endometrial biopsy in people with Infertility, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of this study is to evaluate the gene expression of the endometrium after an endometrial biopsy in fertile women using Next Generation Sequencing of total RNA. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- 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
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2014to Aug 2016
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fertile women
- Age: 18-40 years
- BMI: 18-32
- Regular menstrual cycle
- No use of hormonal contraceptives or IUD the last 3 months
Who cannot join
- Patients in need of a interpreter
- Suspected intrauterine abnormalities
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the gene expression of the endometrium after an endometrial biopsy in fertile women using Next Generation Sequencing of total RNA.
Read the detailed description
An endometrial biopsy is done at cycle day LH+7 and repeated in the next cycle at cycle day LH+7.
Tissue is analysed and compared for changes in gene expression profile using Seq RNA
- Conditions
- Infertility
- Being tested
- endometrial biopsy
- Keywords
- Infertility, Endometrium, Endometrial biopsy, Gene expression
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endometrial biopsyProcedure or surgery
Also called Pipelle de Cornier
| Study group | Role | What they receive |
|---|---|---|
| endometrial biopsy | Other | Not described Receives: Procedure: endometrial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene Expression of the Endometrium after an endometrial biopsy
An endometrial biopsy is done at cycle day LH+7 and repeated in the next cycle at cycle day LH+7.
Endometrial tissue is analysed for changes in gene expression profile of various chemokines and cytokines using RNA Sequencing technology
Measured: 1 month between each biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Axel Forman, MD, DMsc, Study director, Departement of Gynaecology and Obstetrics, Aarhus UniversityMia Steengaard Olesen, MD, Principal investigator, Fertility Clinic Horsens Hospital, Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219425
- Sponsor's protocol ID
- Miacol-2014-2H
- Status last verified
- Aug 2016
- First submitted
- 11 Jul 2014
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression Analysis of the Endometrium After Endometrial Biopsy in Fertile Women
- ClinicalTrials.gov ID
- NCT02219425
- Acronym / sponsor ID
- Miacol-2014-2H
- Conditions
- Infertility
- Keywords
- Infertility, Endometrium, Endometrial biopsy, Gene expression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 18 Aug 2014 (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.
The aim of this study is to evaluate the gene expression of the endometrium after an endometrial biopsy in fertile women using Next Generation Sequencing of total RNA.
Detailed description
An endometrial biopsy is done at cycle day LH+7 and repeated in the next cycle at cycle day LH+7.
Tissue is analysed and compared for changes in gene expression profile using Seq RNA
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endometrial biopsy | Other | Procedure: endometrial biopsy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Fertile women
- Age: 18-40 years
- BMI: 18-32
- Regular menstrual cycle
- No use of hormonal contraceptives or IUD the last 3 months
Key exclusion criteria (3 listed)
- Patients in need of a interpreter
- Suspected intrauterine abnormalities
- Pregnancy
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 biopsyAlso: Pipelle de Cornier | Procedure or surgery | endometrial biopsy |
Primary outcome
Gene Expression of the Endometrium after an endometrial biopsy
Time frame: 1 month between each biopsy
An endometrial biopsy is done at cycle day LH+7 and repeated in the next cycle at cycle day LH+7. Endometrial tissue is analysed for changes in gene expression profile of various chemokines and cytokines using RNA Sequencing technology
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 31 Jan 2017.
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
Axel Forman, MD, DMsc study director
Departement of Gynaecology and Obstetrics, Aarhus University
Mia Steengaard Olesen, MD principal investigator
Fertility Clinic Horsens Hospital, Aarhus University
1 site 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 Infertility, run by University of Aarhus 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 5 inclusion and 3 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 31 Jan 2017. 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?
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?
Gene Expression of the Endometrium after an endometrial biopsy (time frame: 1 month between each biopsy). 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 31 Jan 2017.