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This study was a single-center randomized controlled trial at the Affiliated Drum Tower Hospital of Nanjing University Medical School. There were patients who underwent clinical follow-ups since 2018 in POF clinic. Patients were given treatment of either UCA-PSC or WJ-MSC.
At entry, all patients had already received a standard non-physiologic hormone replacement regimen. According to blinded preferences for participation, patients were randomized into two treatment groups after an initial 2-month washout period of no therapy. One group received UCA-PSC transplantation plus horone replacement treatment (HRT) (UCA-PSC group), while the other group received WJ-MSC transplantation plus HRT (collagen/WJ-MSC group)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCA-PSC | Experimental | Subsequent to isolation and culture of UCA-PSCs, UCA-PSCs (GMP grade, from Clinical Center for Stem Cell Research of the Affiliated Drum Tower Hospital of Nanjing University Medical School, licensed by the National Institute for China Food and Drug Control) were injected into the ovaries of patients with hormone replacement treatment, which consisted of Premarin (0.625 mg/days on days 1 through 25) combined with Provera (10 mg/day for 10 days a month with monthly withdrawal bleeding). |
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| WJ-MSC | Experimental | Subsequent to isolation and culture of WJ-MSCs, WJ-MSCs (GMP grade, from Clinical Center for Stem Cell Research of the Affiliated Drum Tower Hospital of Nanjing University Medical School, licensed by the National Institute for China Food and Drug Control) were injected into the ovaries of patients with hormone replacement treatment, which consisted of Premarin (0.625 mg/days on days 1 through 25) combined with Provera (10 mg/day for 10 days a month with monthly withdrawal bleeding). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transplantation of human UCA-PSCs or WJ-MSCs into ovaries of POF patients | Procedure | After vaginal sterilization, TVUS-guided transplantation was performed by the senior-level medical physician B Wang), using a SIEMENS ACUSON ANTANES premium edition system (SIEMENS AG Healthcae Sector, Erlangen, Germany), equipped with a 6-10 MHz probe. The solution (a total number of 2×10^7cells, 1×10^7 /400 μL for unilateral ovarian injection) was injected into the ovary by using 21G PTC needles (Hakko Medical Co, Japan) under TVUS guiance. Each patent received up to three transplantations. |
| Measure | Description | Time Frame |
|---|---|---|
| blood perfusion in the ovary | Systolic/Diastolic blood pressure (S/D) value was monitored in bilateral ovaries by transvaginal color Doppler ultrasound detector. | within the first 30 weeks (plus or minus 10 weeks) after surgery |
| Antral Follicle Diameter | An antral follicle (or Graafian follicle) is an ovarian follicle during a certain latter stage of folliculogenesis. The antral follicle diameter in the ovaries were record using transvaginal ultrasound scan. | within the first 30 weeks (plus or minus 10 weeks) after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| blood flow index in the ovaries | The blood flow spectrum in bilateral ovaries was monitored by transvaginal color Doppler ultrasound detector, including pulsatility index (PI), resistance index (RI). | within the first 30 weeks (plus or minus 10 weeks) after surgery |
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Inclusion Criteria:
Exclusion Criteria:
Study of POF is only for people whose physical sex is female.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School | Nanjing | Jiangsu | 210008 | 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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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |