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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05138367
Other study ID # SZ-POF-2018-12
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 1, 2018
Est. completion date December 1, 2019

Study information

Verified date November 2021
Source Nanjing University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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)


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 1, 2019
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 39 Years
Eligibility Inclusion Criteria: 1. Clinical diagnosis of Premature Ovarian Failure 2. Patients show no response to drug treatment 3. Willing to receive follow up 4. Willing to conceive a baby 5. Age between 18 to 39 Exclusion Criteria: 1. Patients with chromosome abnormalities 2. Patients with congenital ovarian malformations 3. Patients with severe endometriosis 4. Patients with thyroid dysfunction 5. Patients with pregnancy contraindications 6. Patients with hormone replacement therapy contraindications 7. Past history of ovarian tumors or after radiotherapy 8. Can not take the follow-up, or want to take other treatment during the follow-up period 9. Patients with immune system diseases

Study Design


Intervention

Procedure:
transplantation of human UCA-PSCs or WJ-MSCs into ovaries of POF patients
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.

Locations

Country Name City State
China Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Li-jun Ding

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Secondary 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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