CClinicalTrials.gg
CompletedNCT02863614Updated May 8, 2018

Analgesia for Endometrial Scratching

An interventional study of Ibuprofen 600 mg and Lorazepam 1 mg in Subfertility and Infertility, sponsored by University of Sao Paulo. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-08.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled May 2015, registered Aug 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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

02

Conditions studied

  • Subfertility
  • Infertility

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03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 150 is above the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
150 participants (actual)

Study arms

  • 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: Ibuprofen 600 mg · Drug: Placebo

  • Placebo comparator
    Placebo

    Placebo + Placebo; one hour before endometrial scratching.

    Drug: Placebo

Interventions

  • DrugIbuprofen 600 mg
  • DrugLorazepam 1 mg
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Maximum pain during procedure

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

    Time frame: 5 minutes

Secondary outcomes

  1. Pain after the procedure

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

    Time frame: 5 minutes

  2. 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.

    Time frame: 5 minutes

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02863614
Lead sponsor
University of Sao Paulo
Responsible party
Wellington P Martins, MD (Associate Professor, University of Sao Paulo) — Principal investigator
First posted
Aug 11, 2016
Start date
May 2015
Primary completion
May 2017
Completion
May 2017
Last update
May 8, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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