Effects of UCA-PSCs in Women With POF

Li-jun Ding20 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Premature Ovarian Failure

Interventions

transplantation of human UCA-PSCs or WJ-MSCs into ovaries of POF patientsPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 39 Years

Medical Language ↔ Plain English

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

Locations (1)

Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

blood perfusion in the ovary

Systolic/Diastolic blood pressure (S/D) value was monitored in bilateral ovaries by transvaginal color Doppler ultrasound detector.

Time frame: 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.

Time frame: within the first 30 weeks (plus or minus 10 weeks) after surgery

Secondary Outcomes

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).

Time frame: within the first 30 weeks (plus or minus 10 weeks) after surgery

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.