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Therapeutic Endometrial Biopsy

Primary Purpose

Infertility, Endometrium, ART

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Endometrial biopsy
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Fertility Clinic, Dronninglund Hospital (Aalborg University Hospital)Recruiting
  • Fertility Clinic, Horsens HospitalRecruiting
  • Fertility Clinic, Skive HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

Standard treatment

Endometrial biopsy before standard treatment

Outcomes

Primary Outcome Measures

Rate of clinical pregnancy

Secondary Outcome Measures

Rate of biochemical pregnancy
Rate of implantation
Rate of live birth

Full Information

First Posted
October 11, 2013
Last Updated
March 15, 2018
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT01963819
Brief Title
Therapeutic Endometrial Biopsy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Endometrium, ART, Endometrial Biopsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard treatment
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Endometrial biopsy before standard treatment
Intervention Type
Other
Intervention Name(s)
Endometrial biopsy
Other Intervention Name(s)
Endometrial scratching, Endometrial injury, Local injury to the endometrium
Intervention Description
The endometrial biopsy will be done in the luteal phase (cycle day 18-22) prior to the treatment cycle (antagonist)
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.
Title
Rate of implantation
Time Frame
Individual outcome will be evaluated within 8 weekes after embryo transfer. Overall outcome will be evaluated after 3 years.
Title
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.
Other Pre-specified Outcome Measures:
Title
Rate of pregnancy complications
Description
Placenta abnormalities, pregnancy related hypetensive disorders, IUGR, GDM
Time Frame
Individual outcome will be evaluated within 9 months after embryo transfer. Overall outcome will be evaluated after 3 years.
Title
Data on children and placenta at birth
Description
Gestationel age, Preterm birth, LGA/SGA/NGA, Gender, Placenta abnormalities
Time Frame
Individual outcome will be evaluated within 9 months after embryo transfer. Overall outcome will be evaluated after 3 years.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mia Steengaard Olesen, MD
Phone
+4578426562
Email
miaolsen@rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Axel Forman, MD, DMsc
Email
axel.forman@ki.au.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Axel Forman, MD, DMsc
Organizational Affiliation
Departement of Gynaecology and Obstetrics, Aarhus University Hospital, Skejby
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Inge E Agerholm, M.Sc, PhD
Organizational Affiliation
Fertility Clinic, Horsens Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Benedicte Hauge, MD
Organizational Affiliation
Fertility Clinic, Horsens Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Humaidan, MD, DMSc
Organizational Affiliation
Fertility Clinic, Skive Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mia Steengaard Olesen, MD
Organizational Affiliation
Fertility Clinic Horsens Hospital, Aarhus University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fertility Clinic, Dronninglund Hospital (Aalborg University Hospital)
City
Dronninglund
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Fertility Clinic, Horsens Hospital
City
Horsens
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mia Steengaard Olesen, MD
Email
miaolsen@rm.dk
Facility Name
Fertility Clinic, Skive Hospital
City
Skive
Country
Denmark
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
31843072
Citation
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.
Results Reference
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Therapeutic Endometrial Biopsy

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