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REFRESH: Receptivity Enhancement by Follicular-phase Renewal After Endometrial ScratcHing

NCT02061228 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-12-18

No results posted yet for this study

Summary

A randomised controlled open-label clinical trial to assess the effect of artificially induced endometrial injury and repair during ovarian stimulation on the clinical pregnancy rate of an antagonist downregulated in-vitro fertilisation cycle

Conditions

Interventions

DEVICE

Pipelle de Cornier®

Women in the intervention group will undergo an endometrial biopsy on the 6th day of ovarian stimulation using a Pipelle de Cornier® (CCD International, Paris, France). This class I individually and sterile-packaged medical device, complies with Directive 93/42/European Economic Community (EEC) and is routinely used in our centre for endometrial sampling. It is comprised of a flexible disposable polypropylene suction cannula with an outer diameter of 3.1 mm and a 2.4 mm diameter opening on the distal end, on one side of the cannula. An inner plunger creates a vacuum essential for the blind endometrial biopsy. After the introduction of the Pipelle into the uterine cavity, it will be rotated 360 degrees and moved up and down four times after withdrawing the piston.

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    lead OTHER

Principal Investigators

  • Samuel Santos-Ribeiro, MD · Universitair Ziekenhuis Brussel

  • Shari Mackens, MD · Universitair Ziekenhuis Brussel

  • Dominic Stoop, PhD · Universitair Ziekenhuis Brussel

  • Herman Tournaye, PhD · Universitair Ziekenhuis Brussel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2018-02-26
Completion
2018-09-30

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02061228 on ClinicalTrials.gov