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

NCT02061228 | Terminated DMC

• 2 other identifiers: 29012014REFRESH2014-000442-29
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Infertility

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  Sample size calculation was based on the adequate sample which would simultaneously 1) allow two safety-check interim analyses (at one-third and two-thirds of recruitment) and 2) have an 80% power to detect an increase of 15% in clinical pregnancy rate (from 32% to 47%) in the intervention group \[using a two-side Fisher-exact test with a significance level (alfa) of 0.05\]. Using a 1:1 randomisation ratio, each group would require approximately 180 patients, adding up to a total of 360 patients required for the trial.

  12 weeks

Secondary Outcomes (3)

• Live-birth rate

  42 weeks

• Complication rate

  42 weeks

• Effect on the endometrial histology and expression

  2 weeks

Study Arms (2)

Control arm

NO INTERVENTION

Women undergoing exogenous gonadotropin ovarian stimulation for ART in an antagonist downregulated cycle.

Induced endometrial injury arm

EXPERIMENTAL

Women undergoing exogenous gonadotropin ovarian stimulation for ART in an antagonist downregulated cycle. Additionally, they will undergo an endometrial biopsy on the 6th day of ovarian stimulation using a Pipelle de Cornier® (CCD International, Paris, France).

Device: Pipelle de Cornier®

Interventions

Pipelle de Cornier® DEVICE

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.

Induced endometrial injury arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Fresh IVF/ICSI cycle
• Antagonist down-regulation
• Signed informed consent

You may not qualify if:

• Other known reasons for impaired implantation (i.e. hydrosalpinx, fibroid distorting the endometrial cavity, Asherman's syndrome, thrombophilia or endometrial tuberculosis)
• Oocyte donation acceptors
• Frozen egg transfers
• Embryos planned to undergo preimplantation genetic diagnosis (PGD)
• BMI \>35 or \<18
• Women already recruited for another trial on medically assisted procreation during the same cycle
• Women who have previously enrolled in the trial
• Those unable to comprehend the investigational nature of the proposed study

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, Belgium

Location

Related Publications (2)

• Mackens S, Santos-Ribeiro S, Racca A, Daneels D, Koch A, Essahib W, Verpoest W, Bourgain C, Van Riet I, Tournaye H, Brosens JJ, Lee YH, Blockeel C, Van de Velde H. The proliferative phase endometrium in IVF/ICSI: an in-cycle molecular analysis predictive of the outcome following fresh embryo transfer. Hum Reprod. 2020 Jan 1;35(1):130-144. doi: 10.1093/humrep/dez218.

  PMID: 31916571 DERIVED

• Santos-Ribeiro S, Mackens S, Tournaye H, Blockeel C, Stoop D. Endometrial receptivity enhancement through induced injury and repair during ovarian stimulation: the Receptivity Enhancement by Follicular-phase Renewal after Endometrial ScratcHing (REFRESH) trial protocol. Hum Reprod Open. 2017 Nov 24;2017(3):hox022. doi: 10.1093/hropen/hox022. eCollection 2017.

  PMID: 30895236 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Samuel Santos-Ribeiro, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

• Shari Mackens, MD

  Universitair Ziekenhuis Brussel

  STUDY CHAIR

• Dominic Stoop, PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

• Herman Tournaye, PhD

  Universitair Ziekenhuis Brussel

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: February 12, 2014
• Study Start: March 1, 2014
• Primary Completion: February 26, 2018
• Study Completion: September 30, 2018
• Last Updated: December 18, 2019

Record last verified: 2019-12

Locations

BE (1)