NCT02863614

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

2 years

First QC Date

August 8, 2016

Last Update Submit

May 7, 2018

Conditions

SubfertilityInfertility

Outcome Measures

Primary Outcomes (1)

  • Maximum pain during procedure

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

    5 minutes

Secondary Outcomes (2)

  • Pain after the procedure

    5 minutes

  • Rejection to a new procedure

    5 minutes

Study Arms (3)

Ibuprofen+Lorazepam

EXPERIMENTAL

Oral ibuprofen (600 mg) + lorazepam (1 mg); one hour before endometrial scratching.

Drug: Ibuprofen 600 mgDrug: Lorazepam 1 mg

Ibuprofen

ACTIVE COMPARATOR

Oral ibuprofen (600 mg) + Placebo; one hour before endometrial scratching.

Drug: Ibuprofen 600 mgDrug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo + Placebo; one hour before endometrial scratching.

Drug: Placebo

Interventions

Ibuprofen 600 mgDRUG
IbuprofenIbuprofen+Lorazepam
Lorazepam 1 mgDRUG
Ibuprofen+Lorazepam
PlaceboDRUG
IbuprofenPlacebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility

Interventions

IbuprofenLorazepam

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 8, 2016

First Posted

August 11, 2016

Study Start

May 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 8, 2018

Record last verified: 2018-05