Analgesia for Endometrial Scratching

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

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

Study Overview

• Status: Completed
• Conditions: Infertility; Subfertility
• Intervention / Treatment: Drug: Placebo; Drug: Ibuprofen 600 mg; Drug: Lorazepam 1 mg

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ibuprofen+Lorazepam; Oral ibuprofen (600 mg) + lorazepam (1 mg); one hour before endometrial scratching.	Drug: Ibuprofen 600 mg; Drug: Lorazepam 1 mg
Active Comparator: Ibuprofen; Oral ibuprofen (600 mg) + Placebo; one hour before endometrial scratching.	Drug: Placebo; Drug: Ibuprofen 600 mg
Placebo Comparator: Placebo; Placebo + Placebo; one hour before endometrial scratching.	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum pain during procedure	Evaluated by both visual analog scale (10 cm) and numeric verbal scale (0 to 10).	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain after the procedure	Evaluated by both visual analog scale (10 cm) and numeric verbal scale (0 to 10).	5 minutes
Rejection to a new procedure	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.	5 minutes

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: August 8, 2016
• First Submitted That Met QC Criteria: August 8, 2016
• First Posted (Estimate): August 11, 2016

Study Record Updates

• Last Update Posted (Actual): May 8, 2018
• Last Update Submitted That Met QC Criteria: May 7, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antiemetics; Gastrointestinal Agents; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Ibuprofen; Lorazepam
• Other Study ID Numbers: CAAE: 36622214.5.0000.5440