InfertilityNCT01963819
Therapeutic Endometrial Biopsy
A study testing Endometrial biopsy in people with Infertility and Endometrium, run by University of Aarhus at 3 sites in Denmark.
Trial summary
The aim of this study is to evaluate the potential benefits in implantation, clinical pregnancy and live birth rates by an endometrial biopsy prior to an IVF/ICSI treatment. Including a follow up on possible pregnancy complications and data on children at birth. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility, Endometrium, ART
- What is being tested?
- Endometrial biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesDenmark
- Study dates
- Jan 2014to Dec 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
- One or more previous failed implantation despite transfer of good quality embryons/blastocyst in a fresh IVF/ICSI treatment
- Planned Antagonist treatment
- Planned Standardized hormone treatment
- FSH: 2-12 IU/L
- Age: 18-40 years
- BMI: 18-32
- Regular menstrual cycles
- Written consent
Who cannot join
- Patients in need for a interpreter
- Suspected intrauterine abnormalities ( fibromes, polyps, adenomyosis, sactosalpinges)
- Planned use og Assisted hatching or use of specialized media
- Previous inclusion in the study
Trial locations and contacts
3 sites in 1 country.
Axel Forman, MD, DMsc contact
Denmark3 sites, 3 recruiting
- Recruiting
Fertility Clinic, Dronninglund Hospital (Aalborg University Hospital)
Dronninglund
- Recruiting
Fertility Clinic, Horsens Hospital
Horsens
Mia Steengaard Olesen, MD, miaolsen@rm.dk
- Recruiting
Fertility Clinic, Skive Hospital
Skive
About this study
The aim of this study is to evaluate the potential benefits in implantation, clinical pregnancy and live birth rates by an endometrial biopsy prior to an IVF/ICSI treatment. Including a follow up on possible pregnancy complications and data on children at birth.
Further it is planned to aspirate secretions from the uterus and take blood samples during the treatment, which presumably can provide information about the mechanisms underlying the possible effect of the treatment.
Read the detailed description
Randomized controlled prospective clinical study.
- Conditions
- Infertility, Endometrium, ART, Endometrial Biopsy
- Being tested
- Endometrial biopsy
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial biopsyOther
Also called Endometrial scratching, Endometrial injury, Local injury to the endometrium
The endometrial biopsy will be done in the luteal phase (cycle day 18-22) prior to the treatment cycle (antagonist)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard treatment |
| Intervention | Experimental | Endometrial biopsy before standard treatment Receives: Other: Endometrial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinical pregnancy
Measured: Individual outcome will be evaluated within 8 weekes after embryo transfer. Overall outcome will be evaluated after 3 years.
Secondary outcomes (3)
Rate of biochemical pregnancy
Measured: Individual outcome will be evaluated within 8 weeks after embryo transfer. Overall outcome will be evaluated after 3 years.
Rate of implantation
Measured: Individual outcome will be evaluated within 8 weekes after embryo transfer. Overall outcome will be evaluated after 3 years.
Rate of live birth
Measured: Individual outcome will be evaluated within 9 months after embryo transfer. Overall outcome will be evaluated after 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
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 University Hospital, SkejbyInge E Agerholm, M.Sc, PhD, Principal investigator, Fertility Clinic, Horsens HospitalBenedicte Hauge, MD, Principal investigator, Fertility Clinic, Horsens HospitalPeter Humaidan, MD, DMSc, Principal investigator, Fertility Clinic, Skive HospitalMia Steengaard Olesen, MD, Principal investigator, Fertility Clinic Horsens Hospital, Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963819
- Sponsor's protocol ID
- Miacol-2013-1H
- Status last verified
- Mar 2018
- First submitted
- 11 Oct 2013
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Olesen MS, Hauge B, Ohrt L, Olesen TN, Roskaer J, Baek V, Elbaek HO, Nohr B, Nyegaard M, Overgaard MT, Humaidan P, Forman A, Agerholm I. Therapeutic endometrial scratching and implantation after in vitro fertilization: a multicenter randomized controlled trial. Fertil Steril. 2019 Dec;112(6):1015-1021. doi: 10.1016/j.fertnstert.2019.08.010.
PubMed 31843072
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Endometrial Biopsy
- ClinicalTrials.gov ID
- NCT01963819
- Acronym / sponsor ID
- Miacol-2013-1H
- Conditions
- Infertility, Endometrium, ART, Endometrial Biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 16 Oct 2013 (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 potential benefits in implantation, clinical pregnancy and live birth rates by an endometrial biopsy prior to an IVF/ICSI treatment. Including a follow up on possible pregnancy complications and data on children at birth.
Further it is planned to aspirate secretions from the uterus and take blood samples during the treatment, which presumably can provide information about the mechanisms underlying the possible effect of the treatment.
Detailed description
Randomized controlled prospective clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard treatment |
| Intervention | Experimental | Other: Endometrial biopsyEndometrial biopsy before standard treatment |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- One or more previous failed implantation despite transfer of good quality embryons/blastocyst in a fresh IVF/ICSI treatment
- Planned Antagonist treatment
- Planned Standardized hormone treatment
- FSH: 2-12 IU/L
- Age: 18-40 years
Key exclusion criteria (4 listed)
- Patients in need for a interpreter
- Suspected intrauterine abnormalities ( fibromes, polyps, adenomyosis, sactosalpinges)
- Planned use og Assisted hatching or use of specialized media
- Previous inclusion in the study
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: Endometrial scratching, Endometrial injury, Local injury to the endometriumThe endometrial biopsy will be done in the luteal phase (cycle day 18-22) prior to the treatment cycle (antagonist) | Other | Intervention |
Primary outcome
Rate of clinical pregnancy
Time frame: Individual outcome will be evaluated within 8 weekes after embryo transfer. Overall outcome will be evaluated after 3 years.
3 secondary outcomes
Rate of biochemical pregnancy
Time frame: Individual outcome will be evaluated within 8 weeks after embryo transfer. Overall outcome will be evaluated after 3 years.
Rate of implantation
Time frame: Individual outcome will be evaluated within 8 weekes after embryo transfer. Overall outcome will be evaluated after 3 years.
Rate of live birth
Time frame: Individual outcome will be evaluated within 9 months after embryo transfer. Overall outcome will be evaluated after 3 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
- Derived from this study: PubMed 31843072Olesen MS, Hauge B, Ohrt L, Olesen TN, Roskaer J, Baek V, Elbaek HO, Nohr B, Nyegaard M, Overgaard MT, Humaidan P, Forman A, Agerholm I. Therapeutic endometrial scratching and implantation after in vitro fertilization: a multicenter randomized controlled trial. Fertil Steril. 2019 Dec;112(6):1015-1021. doi: 10.1016/j.fertnstert.2019.08.010.
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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.
Axel Forman, MD, DMsc contact
Axel Forman, MD, DMsc study director
Departement of Gynaecology and Obstetrics, Aarhus University Hospital, Skejby
Inge E Agerholm, M.Sc, PhD principal investigator
Fertility Clinic, Horsens Hospital
Benedicte Hauge, MD principal investigator
Fertility Clinic, Horsens Hospital
3 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 Infertility and Endometrium, run by University of Aarhus at 3 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 8 inclusion and 4 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 19 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 3 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mia Steengaard Olesen, MD (+4578426562, miaolsen@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of clinical pregnancy (time frame: Individual outcome will be evaluated within 8 weekes after embryo transfer. Overall outcome will be evaluated after 3 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01963819, which also lists 1 linked publication.
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 19 Mar 2018.