Analgesia for Endometrial Scratching

NCT ID: NCT02863614

Last Updated: 2018-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-05-31

Brief Summary

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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

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Conditions

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Subfertility Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Ibuprofen+Lorazepam

Oral ibuprofen (600 mg) + lorazepam (1 mg); one hour before endometrial scratching.

Group Type EXPERIMENTAL

Ibuprofen 600 mg

Intervention Type DRUG

Lorazepam 1 mg

Intervention Type DRUG

Ibuprofen

Oral ibuprofen (600 mg) + Placebo; one hour before endometrial scratching.

Group Type ACTIVE_COMPARATOR

Ibuprofen 600 mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Placebo

Placebo + Placebo; one hour before endometrial scratching.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Ibuprofen 600 mg

Intervention Type DRUG

Lorazepam 1 mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Exclusion Criteria

\- None
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Wellington P Martins, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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CAAE: 36622214.5.0000.5440

Identifier Type: -

Identifier Source: org_study_id

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