Retained Products of ConceptionNCT05085067
The Efficacy of Auto-cross Linked Hyaluronic Acid Gel in the Prevention of Adhesion Reformation After Hysteroscopic Resection of Retained Products of Conception
A study testing auto-crossed-linked hyaluronic acid gel in people with Retained Products of Conception, run by Fu Xing Hospital, Capital Medical University at 1 site in China.
Trial summary
Retained product of conception (RPOC) is defined by abnormal trophoblastic persistence or retained placenta inside the uterus cavity after a pregnancy independently of the outcome. Untreated RPOC can compromise future fertility. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Retained Products of Conception
- What is being tested?
- auto-crossed-linked hyaluronic acid gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 30 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of retained products of conception
- Written consent obtained
Who cannot join
- Patients with severe complications of medicine and surgery
- Acute or chronic genital tract inflammation
- No understanding or approving the randomized controlled trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
FuxingHospital，Captital Medical University
Beijing, Beijing Municipality, 100038
Xue Yang, Master, +8618810957056, yuanxy515@163.com
Rong L Huo, Doctor, +861088062032, fxyykjc2014@sina.com
About this study
Official title: The Efficacy of Auto-crosslinked Hyaluronic Acid Gel in the Prevention of Adhesion Reformation After Hysteroscopic Resection of Retained Products of Conception:a Randomized Controlled Trial
Retained product of conception (RPOC) is defined by abnormal trophoblastic persistence or retained placenta inside the uterus cavity after a pregnancy independently of the outcome. Untreated RPOC can compromise future fertility. RPOC are generally treated surgically, either by repeated evacuation or by hysteroscopy, which exposes the uterus to additional potential trauma.The combination of trauma to the gravid uterine cavity, hypoestrogenic state at the time of the operation or immediately afterward and local infection is considered to be the pathogenic mechanism of intrauterine adhesions (IUA) , manifested clinically by menstrual abnormalities, infertility and recurrent pregnancy loss.To investigate the efficacy of auto-cross linked hyaluronic acid gel in the prevention of adhesion reformation after hysteroscopic resection of retained products of conception.
After the completion of hysteroscopic resection of retained products of conception, patients will be randomized to one of the two groups by computer-generated numbers: [1] infusing auto-cross linked hyaluronic acid gel into intrauterine cavity in the experimental group; [2] no auto-cross linked hyaluronic acid gel into intrauterine cavity in the control group. Second and third look outpatient hysteroscopy will be performed 4 and 8 weeks after the initial surgery. The patients will be followed up about menstrual pattern at 3 months after the surgery.The patients will be followed up about pregancy outcome at 12 months after the surgery.
- Conditions
- Retained Products of Conception
- Being tested
- auto-crossed-linked hyaluronic acid gel
- Keywords
- Retained Products of Conception, Hysteroscopy, Intrauterine adhesion, Auto-crossed-linked hyaluronic acid gel
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auto-crossed-linked hyaluronic acid gelOther
infusing auto-cross linked hyaluronic acid gel into intrauterine cavity after hysteroscopic treatment because of retained products of conception
| Study group | Role | What they receive |
|---|---|---|
| Group A: no auto-cross linked hyaluronic acid gel | No intervention | no auto-cross linked hyaluronic acid gel into intrauterine cavity after hysteroscopic treatment because of retained products of conception |
| Group B: infusing auto-cross linked hyaluronic acid gel | Experimental | infusing auto-cross linked hyaluronic acid gel into intrauterine cavity after hysteroscopic treatment because of retained products of conception Receives: Other: auto-crossed-linked hyaluronic acid gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adhesion reformation rate at third-look hysteroscopy
Measured: A third-look hysteroscopy will be carried out 8 weeks after the initial operation.Findings are graded according to the American Fertility Society classification.
Adhesion score at third-look hysteroscopy
Measured: A third-look hysteroscopy will be carried out 8 weeks after the initial operation.Findings are graded according to the American Fertility Society classification.
Concentration of the menstrual pattern
Measured: at 3 months after the initial surgery
Pregnancy rate
Measured: at 12-month after the initial surgery
Secondary outcomes (1)
Rate of complications
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start1 Apr 2022
- Primary completion30 Apr 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retained Products of ConceptionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Xing Hospital, Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Xue, Fu Xing Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085067
- Sponsor's protocol ID
- FXHV1.0-2020-11-15
- Status last verified
- Mar 2025
- First submitted
- 8 Oct 2021
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Auto-crosslinked Hyaluronic Acid Gel in the Prevention of Adhesion Reformation After Hysteroscopic Resection of Retained Products of Conception:a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05085067
- Acronym / sponsor ID
- FXHV1.0-2020-11-15
- Conditions
- Retained Products of Conception
- Keywords
- Retained Products of Conception, Hysteroscopy, Intrauterine adhesion, Auto-crossed-linked hyaluronic acid gel
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Fu Xing Hospital, Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 20 Oct 2021 (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.
Retained product of conception (RPOC) is defined by abnormal trophoblastic persistence or retained placenta inside the uterus cavity after a pregnancy independently of the outcome. Untreated RPOC can compromise future fertility. RPOC are generally treated surgically, either by repeated evacuation or by hysteroscopy, which exposes the uterus to additional potential trauma.The combination of trauma to the gravid uterine cavity, hypoestrogenic state at the time of the operation or immediately afterward and local infection is considered to be the pathogenic mechanism of intrauterine adhesions (IUA) , manifested clinically by menstrual abnormalities, infertility and recurrent pregnancy loss.To investigate the efficacy of auto-cross linked hyaluronic acid gel in the prevention of adhesion reformation after hysteroscopic resection of retained products of conception.
After the completion of hysteroscopic resection of retained products of conception, patients will be randomized to one of the two groups by computer-generated numbers: [1] infusing auto-cross linked hyaluronic acid gel into intrauterine cavity in the experimental group; [2] no auto-cross linked hyaluronic acid gel into intrauterine cavity in the control group. Second and third look outpatient hysteroscopy will be performed 4 and 8 weeks after the initial surgery. The patients will be followed up about menstrual pattern at 3 months after the surgery.The patients will be followed up about pregancy outcome at 12 months after the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: no auto-cross linked hyaluronic acid gel | No intervention | –no auto-cross linked hyaluronic acid gel into intrauterine cavity after hysteroscopic treatment because of retained products of conception |
| Group B: infusing auto-cross linked hyaluronic acid gel | Experimental | Other: auto-crossed-linked hyaluronic acid gelinfusing auto-cross linked hyaluronic acid gel into intrauterine cavity after hysteroscopic treatment because of retained products of conception |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of retained products of conception
- Written consent obtained
Key exclusion criteria (3 listed)
- Patients with severe complications of medicine and surgery
- Acute or chronic genital tract inflammation
- No understanding or approving the randomized controlled trial
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 |
|---|---|---|
| auto-crossed-linked hyaluronic acid gelinfusing auto-cross linked hyaluronic acid gel into intrauterine cavity after hysteroscopic treatment because of retained products of conception | Other | Group B: infusing auto-cross linked hyaluronic acid gel |
Primary outcome
Adhesion reformation rate at third-look hysteroscopy
Time frame: A third-look hysteroscopy will be carried out 8 weeks after the initial operation.Findings are graded according to the American Fertility Society classification.
Adhesion score at third-look hysteroscopy
Time frame: A third-look hysteroscopy will be carried out 8 weeks after the initial operation.Findings are graded according to the American Fertility Society classification.
Concentration of the menstrual pattern
Time frame: at 3 months after the initial surgery
Pregnancy rate
Time frame: at 12-month after the initial surgery
1 secondary outcome
Rate of complications
Time frame: up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Retained Products of Conception
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Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
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Intracervical Vasopressin
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Removal of Intrauterine Retained Products of Conception (RPOC) After Miscarriage Guided by Hysteroscopy Trial. A Randomized Controlled Trial.
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Success Rates of Expectant vs. Medical Management for Retained Products After First-Trimester Abortion: Randomized Controlled Trial
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing auto-crossed-linked hyaluronic acid gel in people with Retained Products of Conception, run by Fu Xing Hospital, Capital Medical University 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 12 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xue Yang, Master (8618810957056, yuanxy515@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adhesion reformation rate at third-look hysteroscopy (time frame: A third-look hysteroscopy will be carried out 8 weeks after the initial operation.Findings are graded according to the American Fertility Society classification.). The study lists 4 primary outcomes in all. 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 12 Mar 2025.