NCT01963819

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 19, 2018

Status Verified

March 1, 2018

Enrollment Period

4.9 years

First QC Date

October 11, 2013

Last Update Submit

March 15, 2018

Conditions

InfertilityEndometriumARTEndometrial Biopsy

Outcome Measures

Primary Outcomes (1)

  • Rate of clinical pregnancy

    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

    Individual outcome will be evaluated within 8 weeks after embryo transfer. Overall outcome will be evaluated after 3 years.

  • Rate of implantation

    Individual outcome will be evaluated within 8 weekes after embryo transfer. Overall outcome will be evaluated after 3 years.

  • Rate of live birth

    Individual outcome will be evaluated within 9 months after embryo transfer. Overall outcome will be evaluated after 3 years.

Other Outcomes (2)

  • Rate of pregnancy complications

    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

    Individual outcome will be evaluated within 9 months after embryo transfer. Overall outcome will be evaluated after 3 years.

Study Arms (2)

Control

NO INTERVENTION

Standard treatment

Intervention

EXPERIMENTAL

Endometrial biopsy before standard treatment

Other: Endometrial biopsy

Interventions

Endometrial biopsyOTHER

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

Also known as: Endometrial scratching, Endometrial injury, Local injury to the endometrium
Intervention

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Patients in need for a interpreter
  • Suspected intrauterine abnormalities ( fibromes, polyps, adenomyosis, sactosalpinges)
  • Planned use og Assisted hatching or use of specialized media

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Fertility Clinic, Dronninglund Hospital (Aalborg University Hospital)

Dronninglund, Denmark

RECRUITING

Fertility Clinic, Horsens Hospital

Horsens, Denmark

RECRUITING

Fertility Clinic, Skive Hospital

Skive, Denmark

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31843072DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Axel Forman, MD, DMsc

    Departement of Gynaecology and Obstetrics, Aarhus University Hospital, Skejby

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mia Steengaard Olesen, MD

CONTACT

+4578426562miaolsen@rm.dk

Axel Forman, MD, DMsc

CONTACT

axel.forman@ki.au.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2013

First Posted

October 16, 2013

Study Start

January 1, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 19, 2018

Record last verified: 2018-03

Locations

DK(3)