EndometriosisNCT05360875
The Effect of Endometrial Scratching on Patients With Endometriosis
A study testing Endometrial scratching in people with Endometriosis and IVF, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
We aimed to investigate whether endometrial scratching could improve IVF outcomes by enhancing endometrial receptivity in patients with endometriosis. Read more about this study
- Who is it for?
- Ages 22 to 40 years, women only
- Conditions the study is for
- Endometriosis, IVF
- What is being tested?
- Endometrial scratching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 30 Jun 2023
- 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 22 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1.Endometriosis that surgery or pathology confirmed; 2. normal ovarian reserve; 3. at least one implantation failure history
Who cannot join
- 1. hydrosalpinx; 2.ademomyosis; 3.endocrine or self-immune disease; 4.serious medical condition; 5.Contraindications of intrauterine operation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Qi Yu, professor, 13701227034, yuqi2008001@sina.com
About this study
Official title: The Effect of Endometrial Scratching on Patients With Endometriosis Undergoing IVF Treatment
We aimed to investigate whether endometrial scratching could improve IVF outcomes by enhancing endometrial receptivity in patients with endometriosis.
- Conditions
- Endometriosis, IVF
- Being tested
- Endometrial scratching
- Keywords
- Endometriosis, Endometrial scratching, Endometrial receptivity, IVF, Pregnancy rates
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial scratchingProcedure or surgery
An intrauterine procedure that causes mild endometrial injury
| Study group | Role | What they receive |
|---|---|---|
| Endometrial scratching group | Experimental | Not described Receives: Procedure: Endometrial scratching |
| Non-scratching group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
pregnancy sacs confirmed by ultrasound
Measured: 6-7 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start1 May 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qi Yu, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360875
- Sponsor's protocol ID
- HS-2065
- Status last verified
- May 2022
- First submitted
- 1 May 2022
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Endometrial Scratching on Patients With Endometriosis Undergoing IVF Treatment
- ClinicalTrials.gov ID
- NCT05360875
- Acronym / sponsor ID
- HS-2065
- Conditions
- Endometriosis, IVF
- Keywords
- Endometriosis, Endometrial scratching, Endometrial receptivity, IVF, Pregnancy rates
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 4 May 2022 (actual)
- 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.
We aimed to investigate whether endometrial scratching could improve IVF outcomes by enhancing endometrial receptivity in patients with endometriosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometrial scratching group | Experimental | Procedure: Endometrial scratching |
| Non-scratching group | No intervention | – |
Who may qualify
- Ages
- 22 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1.Endometriosis that surgery or pathology confirmed; 2. normal ovarian reserve; 3. at least one implantation failure history
Key exclusion criteria (1 listed)
- 1. hydrosalpinx; 2.ademomyosis; 3.endocrine or self-immune disease; 4.serious medical condition; 5.Contraindications of intrauterine operation
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 |
|---|---|---|
| Endometrial scratchingAn intrauterine procedure that causes mild endometrial injury | Procedure or surgery | Endometrial scratching group |
Primary outcome
clinical pregnancy rate
Time frame: 6-7 weeks of gestation
pregnancy sacs confirmed by ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endometrial scratching in people with Endometriosis and IVF, run by Peking Union Medical College Hospital at 1 site in China.
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 1 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: status not confirmed, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical pregnancy rate (time frame: 6-7 weeks of gestation). 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 4 May 2022.