Premature Ovarian Failure
Conditions
Keywords
POF
Brief 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.
Detailed 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)
Interventions
PROCEDUREtransplantation 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.
Sponsors
Li-jun Ding
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| blood perfusion in the ovary | within the first 30 weeks (plus or minus 10 weeks) after surgery | Systolic/Diastolic blood pressure (S/D) value was monitored in bilateral ovaries by transvaginal color Doppler ultrasound detector. |
| Antral Follicle Diameter | within the first 30 weeks (plus or minus 10 weeks) after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood flow index in the ovaries | within the first 30 weeks (plus or minus 10 weeks) after surgery | The blood flow spectrum in bilateral ovaries was monitored by transvaginal color Doppler ultrasound detector, including pulsatility index (PI), resistance index (RI). |
Countries
China
Outcome results
None listed