Therapeutic Endometrial Biopsy

NCT ID: NCT01963819

Last Updated: 2018-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2018-12-31

Brief Summary

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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

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Randomized controlled prospective clinical study.

Conditions

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Infertility Endometrium ART Endometrial Biopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Standard treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Endometrial biopsy before standard treatment

Group Type EXPERIMENTAL

Endometrial biopsy

Intervention Type OTHER

The endometrial biopsy will be done in the luteal phase (cycle day 18-22) prior to the treatment cycle (antagonist)

Interventions

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Endometrial biopsy

The endometrial biopsy will be done in the luteal phase (cycle day 18-22) prior to the treatment cycle (antagonist)

Intervention Type OTHER

Other Intervention Names

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Endometrial scratching Endometrial injury Local injury to the endometrium

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Axel Forman, MD, DMsc

Role: STUDY_DIRECTOR

Departement of Gynaecology and Obstetrics, Aarhus University Hospital, Skejby

Inge E Agerholm, M.Sc, PhD

Role: PRINCIPAL_INVESTIGATOR

Fertility Clinic, Horsens Hospital

Benedicte Hauge, MD

Role: PRINCIPAL_INVESTIGATOR

Fertility Clinic, Horsens Hospital

Peter Humaidan, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Fertility Clinic, Skive Hospital

Mia Steengaard Olesen, MD

Role: PRINCIPAL_INVESTIGATOR

Fertility Clinic Horsens Hospital, Aarhus University

Locations

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Fertility Clinic, Dronninglund Hospital (Aalborg University Hospital)

Dronninglund, , Denmark

Site Status RECRUITING

Fertility Clinic, Horsens Hospital

Horsens, , Denmark

Site Status RECRUITING

Fertility Clinic, Skive Hospital

Skive, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Mia Steengaard Olesen, MD

Role: CONTACT

+4578426562

Axel Forman, MD, DMsc

Role: CONTACT

Facility Contacts

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Mia Steengaard Olesen, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 31843072 (View on PubMed)

Other Identifiers

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Miacol-2013-1H

Identifier Type: -

Identifier Source: org_study_id

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