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NCT02180256 Clinical Trial

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

Subfertility Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02180256
Other study ID # CAAE: 30504514.6.0000.5440
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 2014
Est. completion date June 2016

Study information
Verified date May 2018
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 107
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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:

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Endometrial Scratching
The intentional damage to the endometrium performed with the objective of improving the reproductive outcomes of women desiring pregnancy.

Locations
Country Name City State
Brazil Hc-Fmrp-Usp Ribeirao Preto Sao Paulo

Sponsors (2)
Lead Sponsor Collaborator
University of Sao Paulo Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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. — View 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. Review. Update in: Cochrane Database Syst Rev. 2015;(3):CD009517. — View 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other Implantation rate 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. 8 weeks
Primary 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. 1 year
Secondary 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. 8 weeks
Secondary 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. 20 weeks
Secondary 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. 8 weeks
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