Primary Ovarian InsufficiencyPhase 1/2NCT03033277
Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Women With Primary Ovarian Insufficiency (POI)
A Phase 1/2 study testing HUC-MSCs transplantation in people with Primary Ovarian Insufficiency, run by Chinese Academy of Sciences at 1 site in China.
Trial summary
There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). One of the most common treatments for POI is hormone replacement therapy (HRT), but HRT doesn't work well, and it has been shown to increase the risk of blood clots in the veins, ovarian cancer, and breast cancer. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Primary Ovarian Insufficiency
- What is being tested?
- HUC-MSCs transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to Jul 2018
- Phase
- Phase 1/2
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with primary ovarian insufficiency;
- Women between 20 and 40 years;
- Have fertility requirements, husband has sperm;
- Willing to sign the Informed Consent Form.
Who cannot join
- Primary amenorrhea;
- Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome);
- Thyroid dysfunction;
- Severe endometriosis;
- Contraindications for pregnancy;
- Prior personal history of ovarian cancer;
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- Unwilling to comply with follow-up schedule or want to take other treatment during the follow-up period;
- History of serious drug allergy or allergic constitution;
- Autoimmune disease, history of severe familial genetic disease;
- HIV+, hepatitis B, C;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of Zoology, Chinese Academy of Sciences.
Beijing, Beijing Municipality, 100101
Jianqiao Liu, Doctor, +86-18928916736, ljq88gz@163.com
Yixuan Wu, Doctor, +86-13430202696, 87295667@qq.com
About this study
There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). One of the most common treatments for POI is hormone replacement therapy (HRT), but HRT doesn't work well, and it has been shown to increase the risk of blood clots in the veins, ovarian cancer, and breast cancer. The ability of MSCs to differentiate into oocyte-like cells has been previously documented. Herein the purpose of this work is to evaluate the therapeutic potential of cell therapy in women suffering from POI.
- Conditions
- Primary Ovarian Insufficiency
- Being tested
- Placebo transplantation, HUC-MSCs transplantation
- 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.
Placebo transplantationBiological
Intraovarian injection of placebo through vagina under the guidance of ultrasonic.
HUC-MSCs transplantationBiological
Intraovarian injection of HUC-MSCs through vagina under the guidance of ultrasonic.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Hormone replacement therapy, placebo transplantation. Receives: Biological: Placebo transplantation |
| Experimental group | Experimental | Hormone replacement therapy,HUC-MSCs transplantation. Receives: Biological: HUC-MSCs transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of mature follicle
The number of mature follicles developing was recorded by transvaginal ultrasound scan
Measured: Up to 4 months
Secondary outcomes (6)
Follicle-stimulating hormone (FSH) serum level
Serum FSH level was evaluated once a month after surgery
Measured: Up to 4 months
Estradiol (E2) serum level
Serum E2 level was evaluated once a month after surgery
Measured: Up to 4 months
Anti-Mullerian hormone (AMH) serum level
Serum AMH level was evaluated once a month after surgery
Measured: Up to 4 months
Number of antral follicle development
The number of antral follicles developing was recorded by transvaginal ultrasound scan
Measured: Up to 4 months
Ovarian volume
The ovarian volume was recorded by transvaginal ultrasound scan
Measured: Up to 4 months
Pregnancy rate
The incidence of pregnancy following transfer of embryos produced from oocytes recovered from follicles developing was assessed by Serum Human Chorionic Gonadotropin (HCG) detection.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study startFeb 2016
- Primary completionApr 2017 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Collaborators
- The Third Affiliated Hospital of Guangzhou Medical University
- Responsible party
- Principal investigator, Hongmei Wang, Chinese Academy of Sciences
- Investigators
- Hongmei Wang, Doctor, Principal investigator, State Key Laboratory of Stem Cell and Reproductive Biology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033277
- Sponsor's protocol ID
- Multi-cited POI Recovery
- Status last verified
- Jan 2017
- First submitted
- 10 Jan 2017
- Last updated
- 26 Jan 2017
- 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 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Women With Primary Ovarian Insufficiency (POI)
- ClinicalTrials.gov ID
- NCT03033277
- Acronym / sponsor ID
- Multi-cited POI Recovery
- Conditions
- Primary Ovarian Insufficiency
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Collaborators
- The Third Affiliated Hospital of Guangzhou Medical University
- Study start
- Feb 2016 (actual)
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 26 Jan 2017 (estimated)
- 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.
There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). One of the most common treatments for POI is hormone replacement therapy (HRT), but HRT doesn't work well, and it has been shown to increase the risk of blood clots in the veins, ovarian cancer, and breast cancer. The ability of MSCs to differentiate into oocyte-like cells has been previously documented. Herein the purpose of this work is to evaluate the therapeutic potential of cell therapy in women suffering from POI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Biological: Placebo transplantationHormone replacement therapy, placebo transplantation. |
| Experimental group | Experimental | Biological: HUC-MSCs transplantationHormone replacement therapy,HUC-MSCs transplantation. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosed with primary ovarian insufficiency;
- Women between 20 and 40 years;
- Have fertility requirements, husband has sperm;
- Willing to sign the Informed Consent Form.
Key exclusion criteria (10 listed)
- Primary amenorrhea;
- Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome);
- Thyroid dysfunction;
- Severe endometriosis;
- Contraindications for pregnancy;
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 |
|---|---|---|
| Placebo transplantationIntraovarian injection of placebo through vagina under the guidance of ultrasonic. | Biological | Control group |
| HUC-MSCs transplantationIntraovarian injection of HUC-MSCs through vagina under the guidance of ultrasonic. | Biological | Experimental group |
Primary outcome
Number of mature follicle
Time frame: Up to 4 months
The number of mature follicles developing was recorded by transvaginal ultrasound scan
6 secondary outcomes
Follicle-stimulating hormone (FSH) serum level
Time frame: Up to 4 months
Estradiol (E2) serum level
Time frame: Up to 4 months
Anti-Mullerian hormone (AMH) serum level
Time frame: Up to 4 months
Number of antral follicle development
Time frame: Up to 4 months
Ovarian volume
Time frame: Up to 4 months
Pregnancy rate
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- 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.
Hongmei Wang, Doctor principal investigator
State Key Laboratory of Stem Cell and Reproductive Biology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HUC-MSCs transplantation in people with Primary Ovarian Insufficiency, run by Chinese Academy of Sciences 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 10 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 26 Jan 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Long Yan, Doctor (+86-15650717331, yanlong@ioz.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of mature follicle (time frame: Up to 4 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 26 Jan 2017; AzTrials last refreshed its copy on 7 Nov 2026.