Mayer Rokitansky Kuster Hauser SyndromeNCT04923217
Quality of Life and Sexual Function in Vaginal Aplasia Patients After Davydov Procedure
An observational study of Mayer Rokitansky Kuster Hauser Syndrome and Quality of Life, run by School of Medicine - Vietnam National University at Ho Chi Minh city at 1 site in Vietnam.
Trial summary
Mayer-Rokitansky-Kuster-Hauser(MRKH) syndrome is described as absence or underdevelopment of vagina and uterus. This condition is extremely rare congenital malformation that affects one in every 5000 female births. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mayer Rokitansky Kuster Hauser Syndrome, Quality of Life, Sexual Function Disturbances
- How many people
- 29 participants
- Where
- 1 siteVietnam
- Study dates
- 13 Dec 2021to 10 Nov 2022
- Phase
- Observational
- 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
Study population: Sample is patients who underwent Davydov procedure to create neovagina at Tu Du hospital, Ho Chi Minh city, Vietnam.
Who may be able to join
- Aged equal or more than 18.
- Diagnosed vaginal agenesis and underwent Davydov procedure to create neovagina at least 6 months.
- Able to listen, understand and answer questions.
Who cannot join
- Disagreed to participate the research.
- Having any conditions that make patient unable to listen, understand and answer questions.
- Having psychological disturbance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Quality of Life and Sexual Function in Vaginal Aplasia Patients After Neovaginal Surgical Procedure by Davydov Method
Mayer-Rokitansky-Kuster-Hauser(MRKH) syndrome is described as absence or underdevelopment of vagina and uterus. This condition is extremely rare congenital malformation that affects one in every 5000 female births. Medical management of MRKH syndrome includes the creation of a neovagina using nonsurgical or surgical procedure. In Vietnam, since 2014, Davydov technique has been used to create neovagina for patients with MRKH syndrome at Tu Du hospital which is the biggest obstetric and gynecological hospital in south of Vietnam. However, the effectiveness of this surgical approach on patient's life and sexual activity hasn't been assessed. The objective of this study is to assess the quality of life, the psychological impact and the sexual function of Vietnamese women with MRKH syndrome after Davydov surgical procedure.
Read the detailed description
This study will be conducted at Tu Du Hospital, Ho Chi Minh City, Vietnam. Female patients diagnosed with Mayer-Rokitansky-Kuster-Hauser (MRKH) syndrome were performed the Davydov procedure to create neovagina at the Anaesthesia and Intensive care department, Tu Du hospital. Based on the Department of Anaesthesia and Intensive care data, a list of potentially eligible patients who underwent Davydov surgery at least six months was made. Because of the impact of the Covid 19 pandemic, the patients could not come to the hospital, so the research team decided to interview the participants online. According to this list, patients will be contacted by telephone to set up an online appointment to assess the effectiveness of the Davydov procedure. The informed consent will be sent by email or mail to the patients who accepted to participate in our research before the enrolment. On appointment day, the investigator will make group telecommunication by an application on cell phone or computer. Efficacy of Davydov procedure according to the functional aspect: the psychological doctors assess the impact of patient's neovagina on life and sexual function through questionnaires involving World Health Organization Quality of life Scale (WHOQoL-BREF), Female Sexual Function Index (FSFI) and self-composed qualitative questionnaire. The interview with a patient will be held individually and conducted by the psychological doctor. The participants will be requested to record the conversation. Because MRKH syndrome is a rare condition, the investigators take all patients who are suitable to inclusion criteria and accept participating in our research.
- Medical subject headings
- Mullerian aplasia, Sexual Dysfunctions, Psychological
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life of women with vaginal agenesis after Davydov procedure
The psychological doctor uses the questionnaire named World Health Organization Quality of Life Scale(WHOQoL-BREF) in the interview to ask patient. The patient's Quality of Life will be assessed based on the WHOQoL-BREF questionnaire 's score. All the results will be collected and calculated subsequently. The raw scores are converted to transformation scores. The first transformation converts scores to range of 4-20 and the second transformation converts domain scores to 0-100 scale. Higher scores reflect better Quality of Life.
Measured: From six months after surgery up to the initiation of the study, assessed up to 1 month
Sexual Function of women with vaginal agenesis after Davydov procedure
The psychological doctor uses the questionnaire named Female Sexual Function Index Scale (FSFI) in the interview to ask patient. The patient's sexual function will be assessed based on the FSFI questionnaire 's score. All the results will be collected and calculated subsequently. The FSFI's minimum total score is 2 and the FSFI's maximum total score is 36. The patient is diagnosed to have sexual dysfunction when the FSFI's total score is less than 26,55.
Measured: From six months after surgery up to the initiation of the study, assessed up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start13 Dec 2021
- Primary completion28 Feb 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- School of Medicine - Vietnam National University at Ho Chi Minh city
- Sponsor type
- University, hospital or other
- Collaborators
- Tu Du Hospital, University of Medicine and Pharmacy at Ho Chi Minh City
- Responsible party
- Principal investigator, Thanh Le Trung Quoc, School of Medicine - Vietnam National University at Ho Chi Minh city
- Investigators
- Lan TN Vuong, PhD, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923217
- Sponsor's protocol ID
- 50/HĐĐĐ-ĐHYD
- Status last verified
- Nov 2022
- First submitted
- 21 May 2021
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Quality of Life and Sexual Function in Vaginal Aplasia Patients After Neovaginal Surgical Procedure by Davydov Method
- ClinicalTrials.gov ID
- NCT04923217
- Acronym / sponsor ID
- 50/HĐĐĐ-ĐHYD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- School of Medicine - Vietnam National University at Ho Chi Minh cityUniversity, hospital or other
- Collaborators
- Tu Du Hospital, University of Medicine and Pharmacy at Ho Chi Minh City
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 11 Jun 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.
Mayer-Rokitansky-Kuster-Hauser(MRKH) syndrome is described as absence or underdevelopment of vagina and uterus. This condition is extremely rare congenital malformation that affects one in every 5000 female births. Medical management of MRKH syndrome includes the creation of a neovagina using nonsurgical or surgical procedure. In Vietnam, since 2014, Davydov technique has been used to create neovagina for patients with MRKH syndrome at Tu Du hospital which is the biggest obstetric and gynecological hospital in south of Vietnam. However, the effectiveness of this surgical approach on patient's life and sexual activity hasn't been assessed. The objective of this study is to assess the quality of life, the psychological impact and the sexual function of Vietnamese women with MRKH syndrome after Davydov surgical procedure.
Detailed description
This study will be conducted at Tu Du Hospital, Ho Chi Minh City, Vietnam. Female patients diagnosed with Mayer-Rokitansky-Kuster-Hauser (MRKH) syndrome were performed the Davydov procedure to create neovagina at the Anaesthesia and Intensive care department, Tu Du hospital. Based on the Department of Anaesthesia and Intensive care data, a list of potentially eligible patients who underwent Davydov surgery at least six months was made. Because of the impact of the Covid 19 pandemic, the patients could not come to the hospital, so the research team decided to interview the participants online. According to this list, patients will be contacted by telephone to set up an online appointment to assess the effectiveness of the Davydov procedure. The informed consent will be sent by email or mail to the patients who accepted to participate in our research before the enrolment. On appointment day, the investigator will make group telecommunication by an application on cell phone or computer. Efficacy of Davydov procedure according to the functional aspect: the psychological doctors assess the impact of patient's neovagina on life and sexual function through questionnaires involving World Health Organization Quality of life Scale (WHOQoL-BREF), Female Sexual Function Index (FSFI) and self-composed qualitative questionnaire. The interview with a patient will be held individually and conducted by the psychological doctor. The participants will be requested to record the conversation. Because MRKH syndrome is a rare condition, the investigators take all patients who are suitable to inclusion criteria and accept participating in our research.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sample is patients who underwent Davydov procedure to create neovagina at Tu Du hospital, Ho Chi Minh city, Vietnam.
Key inclusion criteria (3 listed)
- Aged equal or more than 18.
- Diagnosed vaginal agenesis and underwent Davydov procedure to create neovagina at least 6 months.
- Able to listen, understand and answer questions.
Key exclusion criteria (3 listed)
- Disagreed to participate the research.
- Having any conditions that make patient unable to listen, understand and answer questions.
- Having psychological disturbance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of Life of women with vaginal agenesis after Davydov procedure
Time frame: From six months after surgery up to the initiation of the study, assessed up to 1 month
The psychological doctor uses the questionnaire named World Health Organization Quality of Life Scale(WHOQoL-BREF) in the interview to ask patient. The patient's Quality of Life will be assessed based on the WHOQoL-BREF questionnaire 's score. All the results will be collected and calculated subsequently. The raw scores are converted to transformation scores. The first transformation converts scores to range of 4-20 and the second transformation converts domain scores to 0-100 scale. Higher scores reflect better Quality of Life.
Sexual Function of women with vaginal agenesis after Davydov procedure
Time frame: From six months after surgery up to the initiation of the study, assessed up to 1 month
The psychological doctor uses the questionnaire named Female Sexual Function Index Scale (FSFI) in the interview to ask patient. The patient's sexual function will be assessed based on the FSFI questionnaire 's score. All the results will be collected and calculated subsequently. The FSFI's minimum total score is 2 and the FSFI's maximum total score is 36. The patient is diagnosed to have sexual dysfunction when the FSFI's total score is less than 26,55.
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 18 Nov 2022.
- 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.
Lan TN Vuong, PhD principal investigator
University of Medicine and Pharmacy at Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mayer Rokitansky Kuster Hauser Syndrome and Quality of Life, run by School of Medicine - Vietnam National University at Ho Chi Minh city at 1 site in Vietnam.
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 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: finished, as of the sponsor's last update on 18 Nov 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 Vietnam. 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?
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?
Quality of Life of women with vaginal agenesis after Davydov procedure (time frame: From six months after surgery up to the initiation of the study, assessed up to 1 month). The study lists 2 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 18 Nov 2022.