Premature Ovarian InsufficiencyPhase 1/2CURE-POINCT07510139
A Clinical Study of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Premature Ovarian Insufficiency
A Phase 1/2 study testing YT023 in people with Premature Ovarian Insufficiency, run by International Peace Maternity and Child Health Hospital at 1 site in China.
Trial summary
Clinical Study of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Premature Ovarian Insufficiency 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?
- YT023
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2026to 31 Dec 2028
- Phase
- Phase 1/2
- 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 20 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Able to understand and voluntarily sign the informed consent form (ICF) prior to the initiation of any study-related assessments or procedures; Aged 20 to 39 years (inclusive) at the time of signing the ICF; Meets the diagnostic criteria for premature ovarian insufficiency (POI) ; Has a normal karyotype and no known history of FMR1 premutation (Fragile X syndrome); Has at least one ovary intact.
Who cannot join
- History of primary malignancy; Subjects who are hepatitis B surface antigen (HBsAg)-positive at screening; subjects who are HBsAg-negative but hepatitis B core antibody (HBcAb)-positive with detectable peripheral blood hepatitis B virus (HBV) DNA above the lower limit of detection; subjects who are hepatitis C virus (HCV) antibody-positive with detectable HCV RNA; or subjects who are human immunodeficiency virus (HIV) antibody-positive; Known hypersensitivity to any component of the study treatments; Severe neurocognitive impairment as judged by the investigator; Any comorbidities or other conditions that, in the investigator's opinion, may affect compliance with the protocol or render the subject unsuitable for participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Clinical Study of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Premature Ovarian Insufficiency
Read the detailed description
Premature ovarian insufficiency (POI) is a devastating disease for young women who have not yet completed childbearing.The current clinical diagnostic criteria for POI include oligomenorrhea or amenorrhea lasting more than 4 months before the age of 40, along with two measurements of serum follicle-stimulating hormone (FSH) levels >25 IU/L, taken at least 4 weeks apart. Given the progressive nature of POI, recent domestic expert consensus has proposed the concept of "subclinical POI", defined by FSH levels of 15-25 IU/L, which may facilitate early identification and intervention in clinical practice. As the etiology of POI remains incompletely understood, early-stage patients often present with non-specific clinical manifestations, rapid disease progression, and once ovarian function is exhausted, there are currently no effective therapies to fundamentally restore it. Therefore, early intervention in high-risk women with fertility needs is of particular clinical importance.
This interventional, open-label clinical study is designed to evaluate the safety and efficacy of intra-ovarian administration of YT023 in women with premature ovarian insufficiency (POI). The study aims to assess whether YT023 can improve ovarian function.
- Conditions
- Premature Ovarian Insufficiency
- Being tested
- YT023, Control Arm (Conventional Therapy)
- Keywords
- POI
- 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.
YT023Biological
YT023 is administered via in situ (intra-ovarian) injection
Control Arm (Conventional Therapy)Other
The control group will receive assisted reproductive therapy in accordance with the standard of care at the study site
| Study group | Role | What they receive |
|---|---|---|
| YT023 | Experimental | YT023 treatment group will receive assisted reproductive therapy in accordance with the standard of care at the study site after YT023 treatment Receives: Biological: YT023 |
| Control arm | Other | The control group will receive assisted reproductive therapy in accordance with the standard of care at the study site Receives: Other: Control Arm (Conventional Therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the incidence, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs).
Measured: 2years
Improvement in ovarian reserve function following YT023 treatment.
Changes in ovarian reserve function following YT023 treatment, including levels of follicle-stimulating hormone (FSH), anti-Müllerian hormone (AMH), estradiol (E2), and antral follicle count (AFC).
Measured: 2 years
Secondary outcomes (1)
To evaluate the clinical benefit of changes in patient-reported quality of life.
Fertility Quality of Life (FertiQoL) questionnaire
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start20 Mar 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Peace Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Yuantian Biotechnology Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510139
- Sponsor's protocol ID
- YT023-POI
- Acronym
- CURE-POI
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Premature Ovarian Insufficiency
- ClinicalTrials.gov ID
- NCT07510139
- Acronym / sponsor ID
- CURE-POI / YT023-POI
- Conditions
- Premature Ovarian Insufficiency
- Keywords
- POI
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- International Peace Maternity and Child Health HospitalUniversity, hospital or other
- Collaborators
- Shanghai Yuantian Biotechnology Co., Ltd
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Apr 2026 (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.
Clinical Study of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Premature Ovarian Insufficiency
Detailed description
Premature ovarian insufficiency (POI) is a devastating disease for young women who have not yet completed childbearing.The current clinical diagnostic criteria for POI include oligomenorrhea or amenorrhea lasting more than 4 months before the age of 40, along with two measurements of serum follicle-stimulating hormone (FSH) levels >25 IU/L, taken at least 4 weeks apart. Given the progressive nature of POI, recent domestic expert consensus has proposed the concept of "subclinical POI", defined by FSH levels of 15-25 IU/L, which may facilitate early identification and intervention in clinical practice. As the etiology of POI remains incompletely understood, early-stage patients often present with non-specific clinical manifestations, rapid disease progression, and once ovarian function is exhausted, there are currently no effective therapies to fundamentally restore it. Therefore, early intervention in high-risk women with fertility needs is of particular clinical importance.
This interventional, open-label clinical study is designed to evaluate the safety and efficacy of intra-ovarian administration of YT023 in women with premature ovarian insufficiency (POI). The study aims to assess whether YT023 can improve ovarian function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YT023 | Experimental | Biological: YT023YT023 treatment group will receive assisted reproductive therapy in accordance with the standard of care at the study site after YT023 treatment |
| Control arm | Other | Other: Control Arm (Conventional Therapy)The control group will receive assisted reproductive therapy in accordance with the standard of care at the study site |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Able to understand and voluntarily sign the informed consent form (ICF) prior to the initiation of any study-related assessments or procedures; Aged 20 to 39 years (inclusive) at the time of signing the ICF; Meets the diagnostic criteria for premature ovarian insufficiency (POI) ; Has a normal karyotype and no known history of FMR1 premutation (Fragile X syndrome); Has at least one ovary intact.
Key exclusion criteria (1 listed)
- History of primary malignancy; Subjects who are hepatitis B surface antigen (HBsAg)-positive at screening; subjects who are HBsAg-negative but hepatitis B core antibody (HBcAb)-positive with detectable peripheral blood hepatitis B virus (HBV) DNA above the lower limit of detection; subjects who are hepatitis C virus (HCV) antibody-positive with detectable HCV RNA; or subjects who are human immunodeficiency virus (HIV) antibody-positive; Known hypersensitivity to any component of the study treatments; Severe neurocognitive impairment as judged by the investigator; Any comorbidities or other conditions that, in the investigator's opinion, may affect compliance with the protocol or render the subject unsuitable for participation in the study
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 |
|---|---|---|
| YT023YT023 is administered via in situ (intra-ovarian) injection | Biological | YT023 |
| Control Arm (Conventional Therapy)The control group will receive assisted reproductive therapy in accordance with the standard of care at the study site | Other | Control arm |
Primary outcome
To evaluate the incidence, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs).
Time frame: 2years
Improvement in ovarian reserve function following YT023 treatment.
Time frame: 2 years
Changes in ovarian reserve function following YT023 treatment, including levels of follicle-stimulating hormone (FSH), anti-Müllerian hormone (AMH), estradiol (E2), and antral follicle count (AFC).
1 secondary outcome
To evaluate the clinical benefit of changes in patient-reported quality of life.
Time frame: 2years
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 3 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 YT023 in people with Premature Ovarian Insufficiency, run by International Peace Maternity and Child Health Hospital 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2026. 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.
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?
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?
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?
To evaluate the incidence, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs). (time frame: 2years). 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 3 Apr 2026.