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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:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
150
Primary Endpoint
Maximum pain during procedure

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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