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Clinical Trials/NCT02863614
NCT02863614CompletedNot Applicable

Analgesia for Endometrial Scratching in Subfertile Women: a Randomized Controlled Trial

University of Sao Paulo0 sites150 target enrollmentStarted: May 2015Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
150
Primary Endpoint
Maximum pain during procedure
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

  • Not provided

Arms & Interventions

Ibuprofen+Lorazepam

Experimental

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

Intervention: Ibuprofen 600 mg (Drug)

Ibuprofen+Lorazepam

Experimental

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

Intervention: Lorazepam 1 mg (Drug)

Ibuprofen

Active Comparator

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

Intervention: Ibuprofen 600 mg (Drug)

Ibuprofen

Active Comparator

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

Intervention: Placebo (Drug)

Placebo

Placebo Comparator

Placebo + Placebo; one hour before endometrial scratching.

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Maximum pain during procedure

Time Frame: 5 minutes

Evaluated by both visual analog scale (10 cm) and numeric verbal scale (0 to 10).

Secondary Outcomes

  • Rejection to a new procedure(5 minutes)
  • Pain after the procedure(5 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Wellington P Martins, MD

Associate Professor

University of Sao Paulo

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