Therapeutic Endometrial Biopsy

March 15, 2018 updated by: University of Aarhus

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Randomized controlled prospective clinical study.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Dronninglund, Denmark
        • Recruiting
        • Fertility Clinic, Dronninglund Hospital (Aalborg University Hospital)
      • Horsens, Denmark
        • Recruiting
        • Fertility Clinic, Horsens Hospital
        • Contact:
      • Skive, Denmark
        • Recruiting
        • Fertility Clinic, Skive Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Standard treatment
Experimental: Intervention
Endometrial biopsy before standard treatment
Other: Endometrial biopsy
The endometrial biopsy will be done in the luteal phase (cycle day 18-22) prior to the treatment cycle (antagonist)
Other Names:
  • Endometrial injury
  • Endometrial scratching
  • Local injury to the endometrium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Individual outcome will be evaluated within 8 weekes after embryo transfer. Overall outcome will be evaluated after 3 years.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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.
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.
Individual outcome will be evaluated within 9 months after embryo transfer. Overall outcome will be evaluated after 3 years.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of pregnancy complications
Time Frame: Individual outcome will be evaluated within 9 months after embryo transfer. Overall outcome will be evaluated after 3 years.
Placenta abnormalities, pregnancy related hypetensive disorders, IUGR, GDM
Individual outcome will be evaluated within 9 months after embryo transfer. Overall outcome will be evaluated after 3 years.
Data on children and placenta at birth
Time Frame: Individual outcome will be evaluated within 9 months after embryo transfer. Overall outcome will be evaluated after 3 years.
Gestationel age, Preterm birth, LGA/SGA/NGA, Gender, Placenta abnormalities
Individual outcome will be evaluated within 9 months after embryo transfer. Overall outcome will be evaluated after 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Study Director: Axel Forman, MD, DMsc, Departement of Gynaecology and Obstetrics, Aarhus University Hospital, Skejby
  • Principal Investigator: Inge E Agerholm, M.Sc, PhD, Fertility Clinic, Horsens Hospital
  • Principal Investigator: Benedicte Hauge, MD, Fertility Clinic, Horsens Hospital
  • Principal Investigator: Peter Humaidan, MD, DMSc, Fertility Clinic, Skive Hospital
  • Principal Investigator: Mia Steengaard Olesen, MD, Fertility Clinic Horsens Hospital, Aarhus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 11, 2013

First Submitted That Met QC Criteria

October 11, 2013

First Posted (Estimate)

October 16, 2013

Study Record Updates

Last Update Posted (Actual)

March 19, 2018

Last Update Submitted That Met QC Criteria

March 15, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Miacol-2013-1H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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