Infertility, FemaleNCT03042364
Cytokine Profile of the Uterine Secretome After Therapeutic Endometrial Scratching
A study testing Pipelle de Cornier in people with Infertility, Female, run by University of Aarhus at 4 sites in Denmark.
Trial summary
This study investigates the impact of endometrial scratching on endometrial secretion, when correlated to pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Pipelle de Cornier
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesDenmark
- Study dates
- 1 Oct 2016to 14 Mar 2018
- 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
- No healthy volunteers
- Adult
Who may be able to join
- IVF or ICSI patients with ≥1 previous implantation failure, despite transfer of a top quality embryo or blastocyst.
- Antagonist treatment
- FSH: 2-12 IU/L
- BMI: 18-32
- Regular menstrual cycle
- Written consent
Who cannot join
- Suspected intrauterine abnormalities Planned use of specialized media or AHA
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Fertility Clinic,Aalborg University Hospital
Aalborg
Fertility Clinic, Herlev Hospital
Herlev
Fertility Clinic Horsens Hospital
Horsens
Fertility Clinic, Skive Hospital
Skive
About this study
This study investigates the impact of endometrial scratching on endometrial secretion, when correlated to pregnancy.
- Conditions
- Infertility, Female
- Being tested
- Pipelle de Cornier
- Keywords
- Endometrium, Cytokines, Endometrial secretion, Implantation, Endometrial scratching
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pipelle de CornierOther
RCT with endometrial scratching prior to hormone treatment in ART. Aspiration of uterine secretion at transfer day
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | Standard treatment |
| Intervention | Experimental | Endometrial scratching before standard treatment Receives: Other: Pipelle de Cornier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine profile of the uterine secretome after therapeutic endometrial scratching
The secretome is analyzed using a Multiplex analysis with 45 cytokines, chemokines and growth factors from ProcartaPlex Immunoassay Kit, Affymetrix, eBioscience. The samples are normalized for total protein content using a Nanodrop spectrophometer, and the protein composition is further determined by sodium dodecyl sulphate-polyacrylamide gel electropheresis (SDS-PAGE).
Measured: Within 12 months
Immunoassay Kit:
BDNF, EGF, Eotaxin, FGF-2, GMCSF, GRO-alpha, HGF, IFN alpha, IFN gamma, IL-1RA, IL-1alpha, IL-1 beta, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12p70, IL-13, IL-15, IL17-A, IL-18, IL-21, IL-22, IL-23, IL-27, IL-31, IP-10, LIF, MCP-1, MIP-1 alpha, MIP-1 beta, NGF beta, RANTES, PDGF-BB, PÅIGF-1, SCF, SDF-1 alpha, TNF alpha, TNF beta, VEGF-A, VEGF-D
Measured: Within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start1 Oct 2016
- Primary completion14 Mar 2018
- Study completion14 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042364
- Sponsor's protocol ID
- Miacol-2017-3H
- Status last verified
- Mar 2018
- First submitted
- 31 Jan 2017
- Last updated
- 16 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokine Profile of the Uterine Secretome After Therapeutic Endometrial Scratching
- ClinicalTrials.gov ID
- NCT03042364
- Acronym / sponsor ID
- Miacol-2017-3H
- Conditions
- Infertility, Female
- Keywords
- Endometrium, Cytokines, Endometrial secretion, Implantation, Endometrial scratching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 14 Mar 2018 (actual)
- Study completion
- 14 Mar 2018 (actual)
- First posted
- 3 Feb 2017 (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.
This study investigates the impact of endometrial scratching on endometrial secretion, when correlated to pregnancy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | –Standard treatment |
| Intervention | Experimental | Other: Pipelle de CornierEndometrial scratching before standard treatment |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- IVF or ICSI patients with ≥1 previous implantation failure, despite transfer of a top quality embryo or blastocyst.
- Antagonist treatment
- FSH: 2-12 IU/L
- BMI: 18-32
- Regular menstrual cycle
Key exclusion criteria (1 listed)
- Suspected intrauterine abnormalities Planned use of specialized media or AHA
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 |
|---|---|---|
| Pipelle de CornierRCT with endometrial scratching prior to hormone treatment in ART. Aspiration of uterine secretion at transfer day | Other | Intervention |
Primary outcome
Cytokine profile of the uterine secretome after therapeutic endometrial scratching
Time frame: Within 12 months
The secretome is analyzed using a Multiplex analysis with 45 cytokines, chemokines and growth factors from ProcartaPlex Immunoassay Kit, Affymetrix, eBioscience. The samples are normalized for total protein content using a Nanodrop spectrophometer, and the protein composition is further determined by sodium dodecyl sulphate-polyacrylamide gel electropheresis (SDS-PAGE).
Immunoassay Kit:
Time frame: Within 12 months
BDNF, EGF, Eotaxin, FGF-2, GMCSF, GRO-alpha, HGF, IFN alpha, IFN gamma, IL-1RA, IL-1alpha, IL-1 beta, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12p70, IL-13, IL-15, IL17-A, IL-18, IL-21, IL-22, IL-23, IL-27, IL-31, IP-10, LIF, MCP-1, MIP-1 alpha, MIP-1 beta, NGF beta, RANTES, PDGF-BB, PÅIGF-1, SCF, SDF-1 alpha, TNF alpha, TNF beta, VEGF-A, VEGF-D
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 16 Mar 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pipelle de Cornier in people with Infertility, Female, run by University of Aarhus at 4 sites 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 6 inclusion and 1 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 16 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Cytokine profile of the uterine secretome after therapeutic endometrial scratching (time frame: Within 12 months). The study lists 2 primary outcomes in all. 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 16 Mar 2018.