Mayer Rokitansky Kuster Hauser SyndromeNCT06508151
Neovaginoplasty Using Photoinduced-imine-crosslink Hydrogel in MRKH Patients
A study testing neovaginoplasty and vaginal mold spreaded with photoinduced-imine-crosslink hydrogel and neovaginoplasty and vaginal mold in people with Mayer Rokitansky Kuster Hauser Syndrome, run by Obstetrics & Gynecology Hospital of Fudan University.
Trial summary
Evaluating the effectiveness and safety of neovaginoplasty using photoinduced-imine-crosslink hydrogel in patients with MRKH syndrome by comparing the differences in the degree of squamous epithelialization, vaginal length and width, and sexual life quality. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Mayer Rokitansky Kuster Hauser Syndrome
- What is being tested?
- neovaginoplasty and vaginal mold spreaded with photoinduced-imine-crosslink hydrogel and neovaginoplasty and vaginal mold
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 30 Jun 2026
- 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 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with MRKH syndrome;
- Without previous related treatments; 3)18-35 years old;
- 4)Voluntary agreement to participate in the study, sign the informed consent form, and demonstrate good compliance with follow-up.
Who cannot join
- With any previous artificial colpoplasty or other related treatment;
- With history of diabetes or systemic immune system disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study on the Effectiveness and Safety of Neovaginoplasty Using Photoinduced-imine-crosslink Hydrogel in Patients With Mayer-Rokitansky-Kuster-Hauser Syndrome
Evaluating the effectiveness and safety of neovaginoplasty using photoinduced-imine-crosslink hydrogel in patients with MRKH syndrome by comparing the differences in the degree of squamous epithelialization, vaginal length and width, and sexual life quality.
Read the detailed description
This is a randomized controlled trial. Patients meeting the inclusion criteria will be enrolled in this study: 1)Diagnosed with MRKH syndrome; 2)Without previous treatments; 3)Age: 18-35 years old; 4)Voluntary agreement to participate in the study, sign the informed consent form, and demonstrate good compliance with follow-up.
A centralized block randomization will be used to randomly assign patients to ensure that there will be an equal number of patients (1:1) in the hydrogel group and control group. The sample size is 20.
Under general anesthesia and catheterized bladder, the patient was in the lithotomy position. In the connective tissue plane between the bladder and rectum, the vestiges of the müllerian ducts were identified. With the index finger in the rectum as a direction and protection, Hegar's dilators of increasing size (4.5-10) were pushed through the dimples gently. After that, a double-barreled canal appeared. Then, the raphe between the canals was incised. The neovagina was created. According to the randomization, a vaginal mold spreaded with hydrogel or not was placed. The patients were suggested to wear the vaginal mold continuously over the following 6 months. After that, they were allowed to have the first sexual intercourse. Otherwise, the mold wearing time was 1 h daily, until they had sexual activity at least twice a week.
The primary endpoint is the degree of vaginal squamous epithelialization 1 month, 3 months, 6 months after surgery. The secondary endpoints include neovaginal length and width, sexual life quality, and surgical complications.
- Conditions
- Mayer Rokitansky Kuster Hauser Syndrome
- Being tested
- neovaginoplasty and vaginal mold spreaded with photoinduced-imine-crosslink hydrogel, neovaginoplasty and vaginal mold
- Keywords
- Photoinduced-imine-crosslink hydrogel, MRKH syndrome, Neovaginoplasty
- Medical subject headings
- Mullerian aplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neovaginoplasty and vaginal mold spreaded with photoinduced-imine-crosslink hydrogelProcedure or surgery
Under general anesthesia and catheterized bladder, the patient was in the lithotomy position. In the connective tissue plane between the bladder and rectum, the vestiges of the müllerian ducts were identified. With the index finger in the rectum as a direction and protection, Hegar's dilators of increasing size (4.5-10) were pushed through the dimples gently. After that, a double-barreled canal appeared. Then, the raphe between the canals was incised. The neovagina was created. According to the randomization, a vaginal mold spreaded with hydrogel or not was placed in the neovagina for 6 months. The patients were suggested to wear the vaginal mold continuously over the following 6 months. After that, they were allowed to have the first sexual intercourse. Otherwise, the mold wearing time was 1 h daily, until they had sexual activity at least twice a week.
neovaginoplasty and vaginal moldProcedure or surgery
Under general anesthesia and catheterized bladder, the patient was in the lithotomy position. In the connective tissue plane between the bladder and rectum, the vestiges of the müllerian ducts were identified. With the index finger in the rectum as a direction and protection, Hegar's dilators of increasing size (4.5-10) were pushed through the dimples gently. After that, a double-barreled canal appeared. Then, the raphe between the canals was incised. The neovagina was created. According to the randomization, a vaginal mold spreaded with hydrogel or not was placed in the neovagina for 6 months. The patients were suggested to wear the vaginal mold continuously over the following 6 months. After that, they were allowed to have the first sexual intercourse. Otherwise, the mold wearing time was 1 h daily, until they had sexual activity at least twice a week.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | After neovaginoplasty, a vaginal mold spreaded with photoinduced-imine-crosslink hydrogel was placed in the neovagina. Receives: Procedure: neovaginoplasty and vaginal mold spreaded with photoinduced-imine-crosslink hydrogel |
| Arm 2 | Other | After neovaginoplasty, a vaginal mold was placed in the neovagina directly without anything spreaded. Receives: Procedure: neovaginoplasty and vaginal mold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of vaginal squamous epithelialization
Percentage of squamous epithelialization of neovagina
Measured: 1 month
Degree of vaginal squamous epithelialization
Percentage of squamous epithelialization of neovagina
Measured: 3 months
Degree of vaginal squamous epithelialization
Percentage of squamous epithelialization of neovagina
Measured: 6 months
Secondary outcomes (8)
length of neovagina
length in centimetre, measured by a ruler
Measured: 1 month
length of neovagina
length in centimetre, measured by a ruler
Measured: 3 months
length of neovagina
length in centimetre, measured by a ruler
Measured: 6 months
width of neovagina
width in centimetre, measured by ruler
Measured: 1 month
width of neovagina
width in centimetre, measured by ruler
Measured: 3 months
width of neovagina
width in centimetre, measured by ruler
Measured: 6 months
Sexual life quality
Female Sexual Function Index, a self-reported questionnaire to measure sexual life quality
Measured: 6 months
Sexual life quality
Female Sexual Function Index, a self-reported questionnaire to measure sexual life quality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mayer Rokitansky Kuster Hauser SyndromeStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keqin Hua, Obstetrics & Gynecology Hospital of Fudan University
- Investigators
- Keqin Hua, Doctor, Principal investigator, Obstetrics & Gynecology Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508151
- Sponsor's protocol ID
- 2024-16
- Status last verified
- Jul 2024
- First submitted
- 27 Jun 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang X, Qiu J, Ding J, Hua K. Comparison of neovaginoplasty using acellular porcine small intestinal submucosa graft or Interceed in patients with Mayer-Rokitansky-Kuster-Hauser syndrome. Arch Gynecol Obstet. 2019 Dec;300(6):1633-1636. doi: 10.1007/s00404-019-05352-0. Epub 2019 Oct 30.
PubMed 31667605Bao B, Zeng Q, Li K, Wen J, Zhang Y, Zheng Y, Zhou R, Shi C, Chen T, Xiao C, Chen B, Wang T, Yu K, Sun Y, Lin Q, He Y, Tu S, Zhu L. Rapid fabrication of physically robust hydrogels. Nat Mater. 2023 Oct;22(10):1253-1260. doi: 10.1038/s41563-023-01648-4. Epub 2023 Aug 21.
PubMed 37604908Zhang W, Bao B, Jiang F, Zhang Y, Zhou R, Lu Y, Lin S, Lin Q, Jiang X, Zhu L. Promoting Oral Mucosal Wound Healing with a Hydrogel Adhesive Based on a Phototriggered S-Nitrosylation Coupling Reaction. Adv Mater. 2021 Dec;33(48):e2105667. doi: 10.1002/adma.202105667. Epub 2021 Oct 4.
PubMed 34605063Hong Y, Zhou F, Hua Y, Zhang X, Ni C, Pan D, Zhang Y, Jiang D, Yang L, Lin Q, Zou Y, Yu D, Arnot DE, Zou X, Zhu L, Zhang S, Ouyang H. A strongly adhesive hemostatic hydrogel for the repair of arterial and heart bleeds. Nat Commun. 2019 May 14;10(1):2060. doi: 10.1038/s41467-019-10004-7.
PubMed 31089131
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effectiveness and Safety of Neovaginoplasty Using Photoinduced-imine-crosslink Hydrogel in Patients With Mayer-Rokitansky-Kuster-Hauser Syndrome
- ClinicalTrials.gov ID
- NCT06508151
- Acronym / sponsor ID
- 2024-16
- Conditions
- Mayer Rokitansky Kuster Hauser Syndrome
- Keywords
- Photoinduced-imine-crosslink hydrogel, MRKH syndrome, Neovaginoplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 18 Jul 2024 (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.
Evaluating the effectiveness and safety of neovaginoplasty using photoinduced-imine-crosslink hydrogel in patients with MRKH syndrome by comparing the differences in the degree of squamous epithelialization, vaginal length and width, and sexual life quality.
Detailed description
This is a randomized controlled trial. Patients meeting the inclusion criteria will be enrolled in this study: 1)Diagnosed with MRKH syndrome; 2)Without previous treatments; 3)Age: 18-35 years old; 4)Voluntary agreement to participate in the study, sign the informed consent form, and demonstrate good compliance with follow-up.
A centralized block randomization will be used to randomly assign patients to ensure that there will be an equal number of patients (1:1) in the hydrogel group and control group. The sample size is 20.
Under general anesthesia and catheterized bladder, the patient was in the lithotomy position. In the connective tissue plane between the bladder and rectum, the vestiges of the müllerian ducts were identified. With the index finger in the rectum as a direction and protection, Hegar's dilators of increasing size (4.5-10) were pushed through the dimples gently. After that, a double-barreled canal appeared. Then, the raphe between the canals was incised. The neovagina was created. According to the randomization, a vaginal mold spreaded with hydrogel or not was placed. The patients were suggested to wear the vaginal mold continuously over the following 6 months. After that, they were allowed to have the first sexual intercourse. Otherwise, the mold wearing time was 1 h daily, until they had sexual activity at least twice a week.
The primary endpoint is the degree of vaginal squamous epithelialization 1 month, 3 months, 6 months after surgery. The secondary endpoints include neovaginal length and width, sexual life quality, and surgical complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Procedure: neovaginoplasty and vaginal mold spreaded with photoinduced-imine-crosslink hydrogelAfter neovaginoplasty, a vaginal mold spreaded with photoinduced-imine-crosslink hydrogel was placed in the neovagina. |
| Arm 2 | Other | Procedure: neovaginoplasty and vaginal moldAfter neovaginoplasty, a vaginal mold was placed in the neovagina directly without anything spreaded. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosed with MRKH syndrome;
- Without previous related treatments; 3)18-35 years old;
- 4)Voluntary agreement to participate in the study, sign the informed consent form, and demonstrate good compliance with follow-up.
Key exclusion criteria (2 listed)
- With any previous artificial colpoplasty or other related treatment;
- With history of diabetes or systemic immune system disease.
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 |
|---|---|---|
| neovaginoplasty and vaginal mold spreaded with photoinduced-imine-crosslink hydrogelUnder general anesthesia and catheterized bladder, the patient was in the lithotomy position. In the connective tissue plane between the bladder and rectum, the vestiges of the müllerian ducts were identified. With the index finger in the rectum as a direction and protection, Hegar's dilators of increasing size (4.5-10) were pushed through the dimples gently. After that, a double-barreled canal appeared. Then, the raphe between the canals was incised. The neovagina was created. According to the randomization, a vaginal mold spreaded with hydrogel or not was placed in the neovagina for 6 months. The patients were suggested to wear the vaginal mold continuously over the following 6 months. After that, they were allowed to have the first sexual intercourse. Otherwise, the mold wearing time was 1 h daily, until they had sexual activity at least twice a week. | Procedure or surgery | Arm 1 |
| neovaginoplasty and vaginal moldUnder general anesthesia and catheterized bladder, the patient was in the lithotomy position. In the connective tissue plane between the bladder and rectum, the vestiges of the müllerian ducts were identified. With the index finger in the rectum as a direction and protection, Hegar's dilators of increasing size (4.5-10) were pushed through the dimples gently. After that, a double-barreled canal appeared. Then, the raphe between the canals was incised. The neovagina was created. According to the randomization, a vaginal mold spreaded with hydrogel or not was placed in the neovagina for 6 months. The patients were suggested to wear the vaginal mold continuously over the following 6 months. After that, they were allowed to have the first sexual intercourse. Otherwise, the mold wearing time was 1 h daily, until they had sexual activity at least twice a week. | Procedure or surgery | Arm 2 |
Primary outcome
Degree of vaginal squamous epithelialization
Time frame: 1 month
Percentage of squamous epithelialization of neovagina
Degree of vaginal squamous epithelialization
Time frame: 3 months
Percentage of squamous epithelialization of neovagina
Degree of vaginal squamous epithelialization
Time frame: 6 months
Percentage of squamous epithelialization of neovagina
8 secondary outcomes
length of neovagina
Time frame: 1 month
length of neovagina
Time frame: 3 months
length of neovagina
Time frame: 6 months
width of neovagina
Time frame: 1 month
width of neovagina
Time frame: 3 months
width of neovagina
Time frame: 6 months
Sexual life quality
Time frame: 6 months
Sexual life quality
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Results publication: PubMed 31667605Zhang X, Qiu J, Ding J, Hua K. Comparison of neovaginoplasty using acellular porcine small intestinal submucosa graft or Interceed in patients with Mayer-Rokitansky-Kuster-Hauser syndrome. Arch Gynecol Obstet. 2019 Dec;300(6):1633-1636. doi: 10.1007/s00404-019-05352-0. Epub 2019 Oct 30.
- Results publication: PubMed 37604908Bao B, Zeng Q, Li K, Wen J, Zhang Y, Zheng Y, Zhou R, Shi C, Chen T, Xiao C, Chen B, Wang T, Yu K, Sun Y, Lin Q, He Y, Tu S, Zhu L. Rapid fabrication of physically robust hydrogels. Nat Mater. 2023 Oct;22(10):1253-1260. doi: 10.1038/s41563-023-01648-4. Epub 2023 Aug 21.
- Results publication: PubMed 34605063Zhang W, Bao B, Jiang F, Zhang Y, Zhou R, Lu Y, Lin S, Lin Q, Jiang X, Zhu L. Promoting Oral Mucosal Wound Healing with a Hydrogel Adhesive Based on a Phototriggered S-Nitrosylation Coupling Reaction. Adv Mater. 2021 Dec;33(48):e2105667. doi: 10.1002/adma.202105667. Epub 2021 Oct 4.
- Results publication: PubMed 31089131Hong Y, Zhou F, Hua Y, Zhang X, Ni C, Pan D, Zhang Y, Jiang D, Yang L, Lin Q, Zou Y, Yu D, Arnot DE, Zou X, Zhu L, Zhang S, Ouyang H. A strongly adhesive hemostatic hydrogel for the repair of arterial and heart bleeds. Nat Commun. 2019 May 14;10(1):2060. doi: 10.1038/s41467-019-10004-7.
- Individual participant dataSharing planned: No
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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.
Keqin Hua, Doctor principal investigator
Obstetrics & Gynecology Hospital of Fudan University
Questions about this trial
What is this clinical trial studying?
A study testing neovaginoplasty and vaginal mold spreaded with photoinduced-imine-crosslink hydrogel and neovaginoplasty and vaginal mold in people with Mayer Rokitansky Kuster Hauser Syndrome, run by Obstetrics & Gynecology Hospital of Fudan University.
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 2 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 18 Jul 2024. 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. 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?
Contact Keqin Hua, Doctor (+86-021-33189900, huakeqinjiaoshou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of vaginal squamous epithelialization (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06508151, which also lists 4 linked publications.
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 18 Jul 2024.