Premature Ovarian InsufficiencyPhase 1/2NCT07115082
Clinical Study on the Safety and Efficacy of Human Amniotic Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency
A Phase 1/2 study testing Climen 21 Tablets and hA-MSCs in people with Premature Ovarian Insufficiency, run by Yan Hongli at 1 site in China.
Trial summary
There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). So far, there was no treatment sufficient enough to cure POI. Cell therapy is a rapidly developing field and have shown immense promise in the treatment of ovarian dysfunction. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Premature Ovarian Insufficiency
- What is being tested?
- Climen 21 Tablets and hA-MSCs
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2024to 30 Mar 2026
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The intention of pregnant women aged >= 20 and < 40, with normal karyotype;
- Oligo/amenorrhea for at least 4 months;
- Elevated FSH level >25 IU/l on two occasions >4 weeks apart;
- Without a history of stem cell therapy and no growth hormone and/or estrogen and progesterone therapy within the previous 3 months;
- Voluntary participation in the study with signed informed consent;
Who cannot join
- Unable to follow the treatment observation process required by the trial;
- Genetic diseases, chromosomal abnormalities, and genetic deficiency that clearly cause premature ovarian insufficiency/premature ovarian failure;
- With breast, uterine, ovarian tumors, or any other benign or malignant tumors;
- Allergic history to drugs or any other things;
- Presence of genetic disorders such as Turner's syndrome, congenital malformations of the reproductive organs.
- Have undergone ovariectomy or have organic gynaecological diseases.
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- Presence of other gynaecological endocrine diseases such as polycystic ovary syndrome.
- Severe functional impairment of vital organs.
- High risk factors for venous thromboembolism and abnormalities in coagulation mechanisms.
- Attending doctor considers inappropriate to take part in.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Open-label, Parallel-controlled Clinical Study of Amniotic Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency
There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). So far, there was no treatment sufficient enough to cure POI. Cell therapy is a rapidly developing field and have shown immense promise in the treatment of ovarian dysfunction. In this study, the investigator will evaluate the safety of human Amniotic mesenchymal stem cells (hA-MSCs) therapy in women suffering from POI.
Read the detailed description
This clinical trial is designed to understand the safety and effectiveness of human amniotic membrane mesenchymal stem cells (hA-MSCs) in the treatment of primary ovarian insufficiency (POI). Human amniotic MSCs were infused back into the patients by intravenous injection. The trial was designed with two groups, 1) the control group by conventional hormone replacement therapy with oral Climen and 2) the stem cell treatment group by intravenous infusion of human amniotic membrane mesenchymal stem cells (hA-MSCs) combined with oral Climen hormone therapy. Patients were followed up every 2 weeks after the post-injection stem cells to observe their outcomes. The investigators focused on safety indicators, but also monitored hormone levels and signs of follicular growth to initially assess the effectiveness of the stem cells.
- Conditions
- Premature Ovarian Insufficiency
- Being tested
- Climen 21 Tablets, hA-MSCs
- Keywords
- hA-MSCs, Premature ovarian insufficiency
- 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.
Climen 21 TabletsDrug
Climen is commonly used clinically as a hormone replacement therapy and was administered to all patients in both the control and experimental groups in this project.
hA-MSCsBiological
The patients who were part of the experimental group were administered oral Clomid medication in conjunction with a combined intravenous injection of human amniotic MSCs.
| Study group | Role | What they receive |
|---|---|---|
| Climen | Active comparator | Hormone replacement therapy (HRT): Take the drug Climen. Each box has 21 tablets. The first 11 tablets contain 2 milligrams of estradiol valerate each. The last 10 tablets contain 2 milligrams of estradiol valerate and 1 milligram of cyproterone acetate each. Begin taking it on the fifth day of your menstrual cycle. Take one tablet every day for seven days. Then, stop taking the medicine for seven days. After that, continue for two cycles in a row. Receives: Drug: Climen 21 Tablets |
| hA-MSCs+Climen | Experimental | The stem cell treatment group will be administered Climen, with the dosage and method of administration to be determined based on the control group. Concurrently, patients will receive the initial infusion of amniotic MSCs intravenously on the third day after the onset of menstruation, with a subsequent infusion administered after one month. The number of stem cells infused was calculated according to 1 million cells per kilogram of body weight. Receives: Drug: Climen 21 Tablets; Biological: hA-MSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature
Body temperature of the participants will be measured fortnightly after injection.
Measured: Up to 24 weeks
Pulse
Pulse of the participants will be measured fortnightly after injection.
Measured: up to 24 weeks
Breaths per minute
Breathing rate of the participants will be measured fortnightly after injection.
Measured: up to 24 weeks
Blood pressure
Both systolic pressure and diastolic pressure of the participants will be assessed fortnightly after injection.
Measured: 0-24 weeks
Secondary outcomes (5)
Follicle-stimulating hormone (FSH) serum level
Serum FSH level will be tested fortnightly after injection.
Measured: Up to 24 weeks
Estradiol (E2) serum level
Serum E2 level will be tested fortnightly after injection.
Measured: Up to 24 weeks
Anti-Mullerian hormone (AMH) serum level
Serum AMH level will be tested fortnightly after injection.
Measured: up to 24 weeks
Number of antral follicle
The number of antral follicles developing will be recorded by transvaginal ultrasound fortnightly after injection.
Measured: up to 24 weeks
Achievement of pregnancy
A transvaginal ultrasound confirmation of gestational sac The hCG levels have reached between 1,000 - 2,000 mIU/mL.
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 posted11 Aug 2025
- Study start15 Oct 2024
- Primary completionDec 2025 (estimated)
- Study completion30 Mar 2026 (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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yan Hongli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yan Hongli, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115082
- Sponsor's protocol ID
- CHEC2023-172
- Status last verified
- Aug 2025
- First submitted
- 26 Mar 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Parallel-controlled Clinical Study of Amniotic Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency
- ClinicalTrials.gov ID
- NCT07115082
- Acronym / sponsor ID
- CHEC2023-172
- Conditions
- Premature Ovarian Insufficiency
- Keywords
- hA-MSCs, Premature ovarian insufficiency
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yan HongliUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 11 Aug 2025 (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.
There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). So far, there was no treatment sufficient enough to cure POI. Cell therapy is a rapidly developing field and have shown immense promise in the treatment of ovarian dysfunction. In this study, the investigator will evaluate the safety of human Amniotic mesenchymal stem cells (hA-MSCs) therapy in women suffering from POI.
Detailed description
This clinical trial is designed to understand the safety and effectiveness of human amniotic membrane mesenchymal stem cells (hA-MSCs) in the treatment of primary ovarian insufficiency (POI). Human amniotic MSCs were infused back into the patients by intravenous injection. The trial was designed with two groups, 1) the control group by conventional hormone replacement therapy with oral Climen and 2) the stem cell treatment group by intravenous infusion of human amniotic membrane mesenchymal stem cells (hA-MSCs) combined with oral Climen hormone therapy. Patients were followed up every 2 weeks after the post-injection stem cells to observe their outcomes. The investigators focused on safety indicators, but also monitored hormone levels and signs of follicular growth to initially assess the effectiveness of the stem cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Climen | Active comparator | Drug: Climen 21 TabletsHormone replacement therapy (HRT): Take the drug Climen. Each box has 21 tablets. The first 11 tablets contain 2 milligrams of estradiol valerate each. The last 10 tablets contain 2 milligrams of estradiol valerate and 1 milligram of cyproterone acetate each. Begin taking it on the fifth day of your menstrual cycle. Take one tablet every day for seven days. Then, stop taking the medicine for seven days. After that, continue for two cycles in a row. |
| hA-MSCs+Climen | Experimental | Drug: Climen 21 Tablets, Biological: hA-MSCsThe stem cell treatment group will be administered Climen, with the dosage and method of administration to be determined based on the control group. Concurrently, patients will receive the initial infusion of amniotic MSCs intravenously on the third day after the onset of menstruation, with a subsequent infusion administered after one month. The number of stem cells infused was calculated according to 1 million cells per kilogram of body weight. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The intention of pregnant women aged >= 20 and < 40, with normal karyotype;
- Oligo/amenorrhea for at least 4 months;
- Elevated FSH level >25 IU/l on two occasions >4 weeks apart;
- Without a history of stem cell therapy and no growth hormone and/or estrogen and progesterone therapy within the previous 3 months;
- Voluntary participation in the study with signed informed consent;
Key exclusion criteria (10 listed)
- Unable to follow the treatment observation process required by the trial;
- Genetic diseases, chromosomal abnormalities, and genetic deficiency that clearly cause premature ovarian insufficiency/premature ovarian failure;
- With breast, uterine, ovarian tumors, or any other benign or malignant tumors;
- Allergic history to drugs or any other things;
- Presence of genetic disorders such as Turner's syndrome, congenital malformations of the reproductive organs.
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 |
|---|---|---|
| Climen 21 TabletsClimen is commonly used clinically as a hormone replacement therapy and was administered to all patients in both the control and experimental groups in this project. | Drug | Climen, hA-MSCs+Climen |
| hA-MSCsThe patients who were part of the experimental group were administered oral Clomid medication in conjunction with a combined intravenous injection of human amniotic MSCs. | Biological | hA-MSCs+Climen |
Primary outcome
Temperature
Time frame: Up to 24 weeks
Body temperature of the participants will be measured fortnightly after injection.
Pulse
Time frame: up to 24 weeks
Pulse of the participants will be measured fortnightly after injection.
Breaths per minute
Time frame: up to 24 weeks
Breathing rate of the participants will be measured fortnightly after injection.
Blood pressure
Time frame: 0-24 weeks
Both systolic pressure and diastolic pressure of the participants will be assessed fortnightly after injection.
5 secondary outcomes
Follicle-stimulating hormone (FSH) serum level
Time frame: Up to 24 weeks
Estradiol (E2) serum level
Time frame: Up to 24 weeks
Anti-Mullerian hormone (AMH) serum level
Time frame: up to 24 weeks
Number of antral follicle
Time frame: up to 24 weeks
Achievement of pregnancy
Time frame: up to 12 months
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 11 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 Climen 21 Tablets and hA-MSCs in people with Premature Ovarian Insufficiency, run by Yan Hongli 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 5 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: looking for participants now, as of the sponsor's last update on 11 Aug 2025. 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?
Contact Hongli Yan PhD, Professor, Reproductive Medici (021-31162338, hongliyan@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperature (time frame: Up to 24 weeks). The study lists 4 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 11 Aug 2025.