Therapeutic Endometrial Biopsy

Not Applicable

• Conditions: Endometrium; ART; Endometrial Biopsy; Infertility
• Interventions: Other: Endometrial biopsy

• Registration Number: NCT01963819
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study First Submitted: 2013-10-11
• Study First Submitted QC: 2013-10-11
• Study First Posted: 2013-10-16
• Study Start: 2014-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-15
• Last Update Posted: 2018-03-19
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Endometrial biopsy	Endometrial biopsy before standard treatment

Primary Outcome Measures

Name	Time	Method
Rate of clinical pregnancy	Individual outcome will be evaluated within 8 weekes after embryo transfer. Overall outcome will be evaluated after 3 years.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Fertility Clinic, Dronninglund Hospital (Aalborg University Hospital); 🇩🇰 Dronninglund, Denmark

Fertility Clinic, Horsens Hospital; 🇩🇰 Horsens, Denmark

Fertility Clinic, Skive Hospital; 🇩🇰 Skive, Denmark