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Effect of Endometrial Scratching on Assisted Reproduction Outcomes: a Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT02180256
Recruitment Status : Terminated (The main investigators are no longer working at the the center)
First Posted : July 2, 2014
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Wellington P Martins, MD, University of Sao Paulo

Brief Summary:
To examine whether endometrial scratching (or injury) using a Pipelle endometrial sampler, performed on the first seven days of the menstrual cycle, is able to improve pregnancy rates in women who will be submitted to a fresh embryo transfer.

Condition or disease Intervention/treatment Phase
Subfertility Procedure: Endometrial Scratching Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Actual Study Start Date : September 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: Endoscratching, non-RIF
Endometrial scratching. Women with no more than 1 previous unsuccessful embryo transfer. Pipelle in the first seven days of the menstrual cycle, just before starting controlled ovarian stimulation.
Procedure: Endometrial Scratching
The intentional damage to the endometrium performed with the objective of improving the reproductive outcomes of women desiring pregnancy.
Other Names:
  • Endometrial injury
  • Endometrial biopsy
  • Endoscratching

No Intervention: Control, non-RIF
No intervention. Women with no more than 1 previous unsuccessful embryo transfer.
Experimental: Endoscratching, RIF
Endometrial scratching. Women with 2 or more previous unsuccessful embryo transfers. Pipelle in the first seven days of the menstrual cycle, just before starting controlled ovarian stimulation.
Procedure: Endometrial Scratching
The intentional damage to the endometrium performed with the objective of improving the reproductive outcomes of women desiring pregnancy.
Other Names:
  • Endometrial injury
  • Endometrial biopsy
  • Endoscratching

No Intervention: Control, RIF
No intervention. Women with 2 or more previous unsuccessful embryo transfers.



Primary Outcome Measures :
  1. Live birth [ Time Frame: 1 year ]
    The number of participants who delivered a living baby in each arm. The denominator will be the number of women randomized to each arm. This outcome will be assessed by examining the medical records and telephone contact.


Secondary Outcome Measures :
  1. Clinical pregnancy [ Time Frame: 8 weeks ]
    The number of participants achieved clinical pregnancy detected by ultrasound (either intrauterine or ectopic). The denominator will be the number of women randomized to each arm. This outcome will be assessed by examining the medical records and telephone contact.

  2. Miscarriage [ Time Frame: 20 weeks ]
    The number of participants who experienced spontaneous loss of a clinical pregnancy before 20 completed weeks of gestational age. The denominator will be the number of women who achieved clinical pregnancy in each arm. This outcome will be assessed by examining the medical records and telephone contact.

  3. Multiple pregnancy [ Time Frame: 8 weeks ]
    The number of pregnant participants with more than one gestational sac (twins/triplets). The denominator will be the number of women who achieved clinical pregnancy in each arm. This outcome will be assessed by examining the medical records and telephone contact.


Other Outcome Measures:
  1. Implantation rate [ Time Frame: 8 weeks ]
    The number of gestational sacs divided by the number of transferred embryos in each arm. This outcome will be assessed by examining the medical records.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • First four days of the menstrual cycle, just before starting controlled ovarian stimulation for planned IVF and fresh embryo transfer.
  • Not have performed endometrial scratching in the last 90 days.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02180256


Locations
Brazil
Hc-Fmrp-Usp
Ribeirao Preto, Sao Paulo, Brazil, 14048-900
Sponsors and Collaborators
University of Sao Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Wellington P Martins, PhD University of Sao Paulo

Publications:
Responsible Party: Wellington P Martins, MD, Researcher, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02180256     History of Changes
Other Study ID Numbers: CAAE: 30504514.6.0000.5440
First Posted: July 2, 2014    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

Keywords provided by Wellington P Martins, MD, University of Sao Paulo:
IVF
ICSI
Embryo transfer
Assisted reproduction
Endometrial injury
Endometrial scratching

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female