Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Women With Primary Ovarian Insufficiency (POI)

Study Overview
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Brief Summary
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There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). One of the most common treatments for POI is hormone replacement therapy (HRT), but HRT doesn't work well, and it has been shown to increase the risk of blood clots in the veins, ovarian cancer, and breast cancer. The ability of MSCs to differentiate into oocyte-like cells has been previously documented. Herein the purpose of this work is to evaluate the therapeutic potential of cell therapy in women suffering from POI.

Official Title
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Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Women With Primary Ovarian Insufficiency (POI)

Conditions
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Primary Ovarian Insufficiency

Intervention / Treatment
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* Biological: Placebo transplantation
* Biological: HUC-MSCs transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with primary ovarian insufficiency; Women between 20 and 40 years; Have fertility requirements, husband has sperm; Willing to sign the Informed Consent Form. Exclusion Criteria: Primary amenorrhea; Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome); Thyroid dysfunction; Severe endometriosis; Contraindications for pregnancy; Prior personal history of ovarian cancer; Unwilling to comply with follow-up schedule or want to take other treatment during the follow-up period; History of serious drug allergy or allergic constitution; Autoimmune disease, history of severe familial genetic disease; HIV+, hepatitis B, C;

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>Hormone replacement therapy, placebo transplantation. | Biological: Placebo transplantation<br>* Intraovarian injection of placebo through vagina under the guidance of ultrasonic.<br>|
| Experimental: Experimental group<br>Hormone replacement therapy,HUC-MSCs transplantation. | Biological: HUC-MSCs transplantation<br>* Intraovarian injection of HUC-MSCs through vagina under the guidance of ultrasonic.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of mature follicle | The number of mature follicles developing was recorded by transvaginal ultrasound scan | Up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follicle-stimulating hormone (FSH) serum level | Serum FSH level was evaluated once a month after surgery | Up to 4 months | 
| Estradiol (E2) serum level | Serum E2 level was evaluated once a month after surgery | Up to 4 months | 
| Anti-Mullerian hormone (AMH) serum level | Serum AMH level was evaluated once a month after surgery | Up to 4 months | 
| Number of antral follicle development | The number of antral follicles developing was recorded by transvaginal ultrasound scan | Up to 4 months | 
| Ovarian volume | The ovarian volume was recorded by transvaginal ultrasound scan | Up to 4 months | 
| Pregnancy rate | The incidence of pregnancy following transfer of embryos produced from oocytes recovered from follicles developing was assessed by Serum Human Chorionic Gonadotropin (HCG) detection. | Up to 12 months |