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

Primary Purpose

Subfertility

Status
Terminated
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Endometrial Scratching
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Subfertility focused on measuring IVF, ICSI, Embryo transfer, Assisted reproduction, Endometrial injury, Endometrial scratching

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:

  • None

Sites / Locations

  • Hc-Fmrp-Usp

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Endoscratching, non-RIF

Control, non-RIF

Endoscratching, RIF

Control, RIF

Arm Description

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.

No intervention. Women with no more than 1 previous unsuccessful embryo transfer.

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.

No intervention. Women with 2 or more previous unsuccessful embryo transfers.

Outcomes

Primary Outcome Measures

Live birth
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

Clinical pregnancy
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.
Miscarriage
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.
Multiple pregnancy
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.

Full Information

First Posted
June 30, 2014
Last Updated
May 7, 2018
Sponsor
University of Sao Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT02180256
Brief Title
Effect of Endometrial Scratching on Assisted Reproduction Outcomes: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
The main investigators are no longer working at the the center
Study Start Date
September 2014 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subfertility
Keywords
IVF, ICSI, Embryo transfer, Assisted reproduction, Endometrial injury, Endometrial scratching

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endoscratching, non-RIF
Arm Type
Experimental
Arm Description
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.
Arm Title
Control, non-RIF
Arm Type
No Intervention
Arm Description
No intervention. Women with no more than 1 previous unsuccessful embryo transfer.
Arm Title
Endoscratching, RIF
Arm Type
Experimental
Arm Description
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.
Arm Title
Control, RIF
Arm Type
No Intervention
Arm Description
No intervention. Women with 2 or more previous unsuccessful embryo transfers.
Intervention Type
Procedure
Intervention Name(s)
Endometrial Scratching
Other Intervention Name(s)
Endometrial injury, Endometrial biopsy, Endoscratching
Intervention Description
The intentional damage to the endometrium performed with the objective of improving the reproductive outcomes of women desiring pregnancy.
Primary Outcome Measure Information:
Title
Live birth
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Clinical pregnancy
Description
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.
Time Frame
8 weeks
Title
Miscarriage
Description
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.
Time Frame
20 weeks
Title
Multiple pregnancy
Description
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.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Implantation rate
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wellington P Martins, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hc-Fmrp-Usp
City
Ribeirao Preto
State/Province
Sao Paulo
ZIP/Postal Code
14048-900
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
24835342
Citation
Nastri CO, Teixeira DM, Ferriani RA, Martins WP. The overlooked endometrial injury underlying hysteroscopy procedures. Reprod Biomed Online. 2014 Jul;29(1):140. doi: 10.1016/j.rbmo.2014.03.021. Epub 2014 Apr 28. No abstract available.
Results Reference
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PubMed Identifier
23754314
Citation
Nastri CO, Ferriani RA, Raine-Fenning N, Martins WP. Endometrial scratching performed in the non-transfer cycle and outcome of assisted reproduction: a randomized controlled trial. Ultrasound Obstet Gynecol. 2013 Oct;42(4):375-82. doi: 10.1002/uog.12539. Epub 2013 Sep 2.
Results Reference
background
PubMed Identifier
23339704
Citation
Nastri CO, Teixeira DM, Martins WP. Endometrial injury in the menstrual cycle prior to assisted reproduction techniques to improve reproductive outcomes. Gynecol Endocrinol. 2013 May;29(5):401-2. doi: 10.3109/09513590.2012.760193. Epub 2013 Jan 22. No abstract available.
Results Reference
background
PubMed Identifier
22786529
Citation
Nastri CO, Gibreel A, Raine-Fenning N, Maheshwari A, Ferriani RA, Bhattacharya S, Martins WP. Endometrial injury in women undergoing assisted reproductive techniques. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD009517. doi: 10.1002/14651858.CD009517.pub2.
Results Reference
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Effect of Endometrial Scratching on Assisted Reproduction Outcomes: a Randomized Controlled Trial

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