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OpenTrials
Completed

NCT Number: NCT02863614

Analgesia for Endometrial Scratching

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

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Key information

Conditions

Subfertility Genital Diseases Infertility Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen 600 mg

Drug

Lorazepam 1 mg

Drug

Placebo

Drug

Primary outcomes

  1. 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

  1. Pain after the procedure

    Time frame: 5 minutes

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

  2. Rejection to a new procedure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 11, 2016
Registry last updated
May 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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