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

Not Applicable

Terminated

• Conditions: Subfertility
• Interventions: Procedure: Endometrial Scratching

• Registration Number: NCT02180256
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-30
• Study First Submitted QC: 2014-07-01
• Study First Posted: 2014-07-02
• Study Start: 2014-09
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-07
• Last Update Posted: 2018-05-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 107

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.

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoscratching, non-RIF	Endometrial Scratching	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.
Endoscratching, RIF	Endometrial Scratching	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.

Primary Outcome Measures

Name	Time	Method
Live birth	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

Name	Time	Method
Multiple pregnancy	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.
Clinical pregnancy	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.
Miscarriage	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.

Trial Locations

Locations (1)

Hc-Fmrp-Usp; 🇧🇷 Ribeirao Preto, Sao Paulo, Brazil