Analgesia for Endometrial Scratching

Not Applicable

Completed

• Conditions: Infertility; Subfertility
• Interventions: Drug: Ibuprofen 600 mg; Drug: Lorazepam 1 mg; Drug: Placebo

• Registration Number: NCT02863614
• Lead Sponsor: University of Sao Paulo

Brief Summary

The aim of this study is to evaluate whether Ibuprofen alone or combined with lorazepam reduce the pain associated with endometrial scratching/injury.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2016-08-08
• Study First Submitted QC: 2016-08-08
• Study First Posted: 2016-08-11
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-07
• Last Update Posted: 2018-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Women aged ≥ 18 years undergoing assisted reproduction (IUI, IVF/ICSI, frozen embryo transfer)
• Being submitted to endometrial scratching/injury with a Pipelle on the first four days of the menstrual cycle.
• 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
Ibuprofen+Lorazepam	Ibuprofen 600 mg	Oral ibuprofen (600 mg) + lorazepam (1 mg); one hour before endometrial scratching.
Ibuprofen+Lorazepam	Lorazepam 1 mg	Oral ibuprofen (600 mg) + lorazepam (1 mg); one hour before endometrial scratching.
Ibuprofen	Placebo	Oral ibuprofen (600 mg) + Placebo; one hour before endometrial scratching.
Placebo	Placebo	Placebo + Placebo; one hour before endometrial scratching.
Ibuprofen	Ibuprofen 600 mg	Oral ibuprofen (600 mg) + Placebo; one hour before endometrial scratching.

Primary Outcome Measures

Name	Time	Method
Maximum pain during procedure	5 minutes	Evaluated by both visual analog scale (10 cm) and numeric verbal scale (0 to 10).

Secondary Outcome Measures

Name	Time	Method
Rejection to a new procedure	5 minutes	Evaluated by a 5-point Likert scale, commenting on this sentence: "I would repeat this procedure if it were indicated". 1 = I fully agree; 2 = I agree; 3 =Neither agree nor disagree; 4 = Disagree; 5 = Strongly Disagree.
Pain after the procedure	5 minutes	Evaluated by both visual analog scale (10 cm) and numeric verbal scale (0 to 10).