Premature Ovarian InsufficiencyNCT05308342
Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency
A study testing transplantation of human UC-MSCs into ovaries of POI patients and hormone replacement treatment in people with Premature Ovarian Insufficiency, run by Li-jun Ding at 1 site in China.
Trial summary
This study was a single-center, randomized, controlled prospective study. Those who had premature ovarian failure and who had fertility requirements were enrolled in the study. To determine the efficacy and safety of umbilical cord mesenchymal stem cells in the treatment of patients with POI. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Premature Ovarian Insufficiency
- What is being tested?
- transplantation of human UC-MSCs into ovaries of POI patients and hormone replacement treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2019to 1 Dec 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 20 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Those who meet the POF diagnostic criteria and have no spontaneous follicular activity;
- Married, 20 years old ≤ age < 40 years old;
- The average diameter of each ovary is > 10 mm;
- Have agreed to sign the informed consent form.
Who cannot join
- Female and/or male chromosomal abnormalities;
- Endometriosis, adenomyosis;
- Postoperative ovarian borderline or malignant tumor;
- Uterine dysplasia;
- Associated with female autoimmune disease or other serious internal surgical diseases;
- hormone replacement contraindications;
- In the past 1 year, had received an experimental study of premature ovarian failure in the external hospital;
- Male azoospermia or severe oligozoospermia.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Haixiang Sun, +86 25 8310 7188, stevensunz@163.com
About this study
This study was a single-center, randomized, controlled prospective study. Those who had premature ovarian failure and who had fertility requirements were enrolled in the study. To determine the efficacy and safety of umbilical cord mesenchymal stem cells in the treatment of patients with POI.
Read the detailed description
According to the enrollment and exclusion criteria, the patients were enrolled, and the subjects were randomly divided into two groups by computer randomization. Group A was hormone replacement combined with transplantation of umbilical cord mesenchymal stem cells (test group). Group B was the hormone replacement group (control group).
- Conditions
- Premature Ovarian Insufficiency
- Being tested
- transplantation of human UC-MSCs into ovaries of POI patients, hormone replacement treatment
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transplantation of human UC-MSCs into ovaries of POI patientsProcedure or surgery
UC-MSCs (GMP grade, from Clinical Center for Stem Cell Research of the Affiliated Drum Tower Hospital of Nanjing University Medical School, licensed by the China Food and Drug Administration) are injected into the ovary of patients under transvaginal ultrasonographic (TVUS)-guidance. A total number of 10×106 cells, 5×106 for unilateral ovarian injection) is immediately preserved and transferred for direct injection. After vaginal sterilization, TVUS-guided transplantation is performed by two senior-level medical physicians, using a SIEMENS ACUSON ANTANES premium edition system (SIEMENS AG Healthcare Sector, Erlangen, Germany), equipped with a 6-10 MHz probe. The UC-MSC solution is injected into the ovary by using 21-G PTC needles (Hakko Medical Co, Japan) under TVUS guidance.
hormone replacement treatmentDrug
Also called HRT
Routine estrogen progesterone replacement periodic therapy
| Study group | Role | What they receive |
|---|---|---|
| UC-MSCs+hormone replacement group | Experimental | Group A was the hormone replacement combined with transplantation of umbilical cord mesenchymal stem cells group(test group). Receives: Procedure: transplantation of human UC-MSCs into ovaries of POI patients; Drug: hormone replacement treatment |
| hormone replacement group | Active comparator | Group B was the hormone replacement group (control group). Receives: Drug: hormone replacement treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follicular development rate
Follicular development and hormonal examination were performed 1 week before treatment and at 1, 2, and 3 weeks after treatment to evaluate the development of follicles. If there is no follicular development in the third week, stop the drug after 1 week, and contact the next treatment time after menstruation. During the follow-up period to half a year after the end of the last treatment, the follicular development activity rate was observed.
Measured: 9-12 months
Secondary outcomes (2)
Changes in blood flow index in the ovary
Ovarian artery blood flow spectrum PI; RI; S/D (L; R)
Measured: 9-12 months
Clinical pregnancy rate
Clinical pregnancy was defined as diagnosed by increasing serum concentration of beta-HCG 14 days after embryo transfer, and the subsequent demonstration of an intrauterine gestational sac by ultrasonography on 30 days after embryo transfer
Measured: 9-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start20 Nov 2019
- Primary completion31 Jul 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian InsufficiencyStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li-jun Ding
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li-jun Ding, Nanjing University
- Investigators
- Guangshu Han, phD, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308342
- Sponsor's protocol ID
- SZ-POF-2019-4
- Status last verified
- Mar 2022
- First submitted
- 25 Nov 2019
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency
- ClinicalTrials.gov ID
- NCT05308342
- Acronym / sponsor ID
- SZ-POF-2019-4
- Conditions
- Premature Ovarian Insufficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Li-jun DingUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 4 Apr 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.
This study was a single-center, randomized, controlled prospective study. Those who had premature ovarian failure and who had fertility requirements were enrolled in the study. To determine the efficacy and safety of umbilical cord mesenchymal stem cells in the treatment of patients with POI.
Detailed description
According to the enrollment and exclusion criteria, the patients were enrolled, and the subjects were randomly divided into two groups by computer randomization. Group A was hormone replacement combined with transplantation of umbilical cord mesenchymal stem cells (test group). Group B was the hormone replacement group (control group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UC-MSCs+hormone replacement group | Experimental | Procedure: transplantation of human UC-MSCs into ovaries of POI patients, Drug: hormone replacement treatmentGroup A was the hormone replacement combined with transplantation of umbilical cord mesenchymal stem cells group(test group). |
| hormone replacement group | Active comparator | Drug: hormone replacement treatmentGroup B was the hormone replacement group (control group). |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Those who meet the POF diagnostic criteria and have no spontaneous follicular activity;
- Married, 20 years old ≤ age < 40 years old;
- The average diameter of each ovary is > 10 mm;
- Have agreed to sign the informed consent form.
Key exclusion criteria (8 listed)
- Female and/or male chromosomal abnormalities;
- Endometriosis, adenomyosis;
- Postoperative ovarian borderline or malignant tumor;
- Uterine dysplasia;
- Associated with female autoimmune disease or other serious internal surgical diseases;
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 |
|---|---|---|
| transplantation of human UC-MSCs into ovaries of POI patientsUC-MSCs (GMP grade, from Clinical Center for Stem Cell Research of the Affiliated Drum Tower Hospital of Nanjing University Medical School, licensed by the China Food and Drug Administration) are injected into the ovary of patients under transvaginal ultrasonographic (TVUS)-guidance. A total number of 10×106 cells, 5×106 for unilateral ovarian injection) is immediately preserved and transferred for direct injection. After vaginal sterilization, TVUS-guided transplantation is performed by two senior-level medical physicians, using a SIEMENS ACUSON ANTANES premium edition system (SIEMENS AG Healthcare Sector, Erlangen, Germany), equipped with a 6-10 MHz probe. The UC-MSC solution is injected into the ovary by using 21-G PTC needles (Hakko Medical Co, Japan) under TVUS guidance. | Procedure or surgery | UC-MSCs+hormone replacement group |
| hormone replacement treatmentAlso: HRTRoutine estrogen progesterone replacement periodic therapy | Drug | UC-MSCs+hormone replacement group, hormone replacement group |
Primary outcome
Follicular development rate
Time frame: 9-12 months
Follicular development and hormonal examination were performed 1 week before treatment and at 1, 2, and 3 weeks after treatment to evaluate the development of follicles. If there is no follicular development in the third week, stop the drug after 1 week, and contact the next treatment time after menstruation. During the follow-up period to half a year after the end of the last treatment, the follicular development activity rate was observed.
2 secondary outcomes
Changes in blood flow index in the ovary
Time frame: 9-12 months
Clinical pregnancy rate
Time frame: 9-12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
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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.
Guangshu Han, phD principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transplantation of human UC-MSCs into ovaries of POI patients and hormone replacement treatment in people with Premature Ovarian Insufficiency, run by Li-jun Ding 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 4 inclusion and 8 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 Apr 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?
Contact Haixiang Sun, phD (+862583107188, stevensunz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follicular development rate (time frame: 9-12 months). 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 Apr 2022.