Therapeutic Endometrial Biopsy

University of Aarhus

Status: Unknown

Conditions: Endometrium; Infertility; Endometrial Biopsy; ART

Treatments: Other: Endometrial biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT01963819

Miacol-2013-1H

Details and patient eligibility

About

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.

Full description

Randomized controlled prospective clinical study.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Control

No Intervention group

Description:

Standard treatment

Intervention

Experimental group

Description:

Endometrial biopsy before standard treatment

Treatment:

Other: Endometrial biopsy