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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Climen 21 Tablets | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Temperature | Body temperature of the participants will be measured fortnightly after injection. | Up to 24 weeks |
| Pulse | Pulse of the participants will be measured fortnightly after injection. | up to 24 weeks |
| Breaths per minute | Breathing rate of the participants will be measured fortnightly after injection. | up to 24 weeks |
| Blood pressure | Both systolic pressure and diastolic pressure of the participants will be assessed fortnightly after injection. | 0-24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Follicle-stimulating hormone (FSH) serum level | Serum FSH level will be tested fortnightly after injection. | Up to 24 weeks |
| Estradiol (E2) serum level | Serum E2 level will be tested fortnightly after injection. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongli Yan PhD, Professor, Reproductive Medici | Contact | 021-31162338 | hongliyan@smmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Changhai Hospital | Recruiting | Shanghai | 200433 | China |
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| ID | Term |
|---|---|
| D016649 | Primary Ovarian Insufficiency |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| hA-MSCs | Biological | 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. |
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| Up to 24 weeks |
| Anti-Mullerian hormone (AMH) serum level | Serum AMH level will be tested fortnightly after injection. | up to 24 weeks |
| Number of antral follicle | The number of antral follicles developing will be recorded by transvaginal ultrasound fortnightly after injection. | 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. | up to 12 months |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |