Therapeutic Endometrial Biopsy

University of Aarhus3 sites in 1 country300 target enrollmentJanuary 2014

ConditionsInfertility Endometrium ART Endometrial Biopsy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infertility
Sponsor: University of Aarhus
Enrollment: 300
Locations: 3
Primary Endpoint: Rate of clinical pregnancy
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2014

End Date

December 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

University of Aarhus

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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 Outcomes

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.)