REFRESH: Receptivity Enhancement by Follicular-phase Renewal After Endometrial ScratcHing
NCT ID: NCT02061228
Last Updated: 2019-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
200 participants
INTERVENTIONAL
2014-03-31
2018-09-30
Brief Summary
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Detailed Description
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All women included will undergo artificial ovarian stimulation with gonadotropin-releasing hormone (GnRH) antagonist downregulation with daily injections of either ganirelix or cetrorelix. Treating physicians will opt on which exogenous gonadotropins should be used according to the patient's profile and preference and can include either recombinant follicle stimulating hormone (FSH) or highly purified urinary human menopausal gonadotropin (HP-HMG). Ovarian stimulation will commence after it is confirmed that the patient is not pregnant and has basal levels of oestradiol, progesterone, FSH and luteinizing hormone (LH). The stimulation will be monitored simultaneously by pelvic ultrasound and hormonal analysis (oestradiol, progesterone), starting on day 6 of stimulation and then every 1 to 3 days, according to the individual endocrine profile and follicular development.
Final oocyte maturation will be triggered with either 5000/10000 IU of human menopausal human chorionic gonadotropin (hCG) or 150 IU of recombinant hCG when more than 2 follicles of ≥17 mm are present. Oocyte retrieval will be performed 36 hours after hCG administration under either local anaesthesia with analgesic premedication or general anaesthesia, according to patient preference.
IVF or IVF/intracytoplasmatic sperm injection (ICSI) will be performed, using the specimen of sperm made available by the male progenitor on the day of oocyte retrieval. According to embryo quality, embryo transfer to the uterine cavity will be performed on either the 3rd or 5th day of development under ultrasound guidance whenever possible. Following embryo transfer, luteal support will be provided with vaginally administered progesterone 200 mg tid.
For clarity, cycle cancelation is defined as any interruption of the ART process that occurs before fresh embryo transfer. Cycle cancelation will occur a) upon patient request, b) if inadequate follicular development occurs, c) if no embryo is available for transfer.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control arm
Women undergoing exogenous gonadotropin ovarian stimulation for ART in an antagonist downregulated cycle.
No interventions assigned to this group
Induced endometrial injury arm
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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Antagonist down-regulation
* Signed informed consent
Exclusion Criteria
* 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
18 Years
40 Years
FEMALE
No
Sponsors
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Universitair Ziekenhuis Brussel
OTHER
Responsible Party
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Samuel Santos-Ribeiro
MD
Principal Investigators
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Samuel Santos-Ribeiro, MD
Role: PRINCIPAL_INVESTIGATOR
Universitair Ziekenhuis Brussel
Shari Mackens, MD
Role: STUDY_CHAIR
Universitair Ziekenhuis Brussel
Dominic Stoop, PhD
Role: PRINCIPAL_INVESTIGATOR
Universitair Ziekenhuis Brussel
Herman Tournaye, PhD
Role: STUDY_CHAIR
Universitair Ziekenhuis Brussel
Locations
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Universitair Ziekenhuis Brussel
Brussels, , Belgium
Countries
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References
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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.
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.
Other Identifiers
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2014-000442-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
29012014REFRESH
Identifier Type: -
Identifier Source: org_study_id