Analgesia for Endometrial Scratching

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02863614
• Other study ID #: CAAE: 36622214.5.0000.5440
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: May 2017

Study information

• Verified date: May 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Subfertility

Intervention

Drug:
• Ibuprofen 600 mg

• Lorazepam 1 mg

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum pain during procedure	Evaluated by both visual analog scale (10 cm) and numeric verbal scale (0 to 10).	5 minutes
Secondary	Pain after the procedure	Evaluated by both visual analog scale (10 cm) and numeric verbal scale (0 to 10).	5 minutes
Secondary	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