SubfertilityNCT02863614
Analgesia for Endometrial Scratching
A study testing Ibuprofen 600 mg and Lorazepam 1 mg in people with Subfertility and Infertility, run by University of Sao Paulo.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Subfertility, Infertility
- What is being tested?
- Ibuprofen 600 mg and Lorazepam 1 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- May 2015to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None
About this study
Official title: 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.
- Conditions
- Subfertility, Infertility
- Being tested
- Ibuprofen 600 mg, Lorazepam 1 mg, Placebo
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 600 mgDrug
Lorazepam 1 mgDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen+Lorazepam | Experimental | Oral ibuprofen (600 mg) + lorazepam (1 mg); one hour before endometrial scratching. Receives: Drug: Ibuprofen 600 mg; Drug: Lorazepam 1 mg |
| Ibuprofen | Active comparator | Oral ibuprofen (600 mg) + Placebo; one hour before endometrial scratching. Receives: Drug: Ibuprofen 600 mg; Drug: Placebo |
| Placebo | Placebo comparator | Placebo + Placebo; one hour before endometrial scratching. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum pain during procedure
Evaluated by both visual analog scale (10 cm) and numeric verbal scale (0 to 10).
Measured: 5 minutes
Secondary outcomes (2)
Pain after the procedure
Evaluated by both visual analog scale (10 cm) and numeric verbal scale (0 to 10).
Measured: 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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startMay 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SubfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wellington P Martins, MD, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863614
- Sponsor's protocol ID
- CAAE: 36622214.5.0000.5440
- Status last verified
- May 2018
- First submitted
- 8 Aug 2016
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia for Endometrial Scratching in Subfertile Women: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02863614
- Acronym / sponsor ID
- CAAE: 36622214.5.0000.5440
- Conditions
- Subfertility, Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate whether Ibuprofen alone or combined with lorazepam reduce the pain associated with endometrial scratching/injury.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen+Lorazepam | Experimental | Drug: Ibuprofen 600 mg, Drug: Lorazepam 1 mgOral ibuprofen (600 mg) + lorazepam (1 mg); one hour before endometrial scratching. |
| Ibuprofen | Active comparator | Drug: Ibuprofen 600 mg, Drug: PlaceboOral ibuprofen (600 mg) + Placebo; one hour before endometrial scratching. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo + Placebo; one hour before endometrial scratching. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen 600 mg | Drug | Ibuprofen, Ibuprofen+Lorazepam |
| Lorazepam 1 mg | Drug | Ibuprofen+Lorazepam |
| Placebo | Drug | Ibuprofen, Placebo |
Primary outcome
Maximum pain during procedure
Time frame: 5 minutes
Evaluated by both visual analog scale (10 cm) and numeric verbal scale (0 to 10).
2 secondary outcomes
Pain after the procedure
Time frame: 5 minutes
Rejection to a new procedure
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ibuprofen 600 mg and Lorazepam 1 mg in people with Subfertility and Infertility, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum pain during procedure (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.