Back to resultsHuman Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Women With Primary Ovarian Insufficiency (POI)
Primary Purpose
Primary Ovarian Insufficiency
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Placebo transplantation
HUC-MSCs transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Primary Ovarian Insufficiency
Eligibility Criteria
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;
Sites / Locations
- Institute of Zoology, Chinese Academy of Sciences.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control group
Experimental group
Arm Description
Hormone replacement therapy, placebo transplantation.
Hormone replacement therapy,HUC-MSCs transplantation.
Outcomes
Primary Outcome Measures
Number of mature follicle
The number of mature follicles developing was recorded by transvaginal ultrasound scan
Secondary Outcome Measures
Follicle-stimulating hormone (FSH) serum level
Serum FSH level was evaluated once a month after surgery
Estradiol (E2) serum level
Serum E2 level was evaluated once a month after surgery
Anti-Mullerian hormone (AMH) serum level
Serum AMH level was evaluated once a month after surgery
Number of antral follicle development
The number of antral follicles developing was recorded by transvaginal ultrasound scan
Ovarian volume
The ovarian volume was recorded by transvaginal ultrasound scan
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.
Full Information
NCT ID
NCT03033277
First Posted
January 10, 2017
Last Updated
January 24, 2017
Sponsor
Chinese Academy of Sciences
Collaborators
The Third Affiliated Hospital of Guangzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03033277
Brief Title
Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Women With Primary Ovarian Insufficiency (POI)
Official Title
Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Women With Primary Ovarian Insufficiency (POI)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (Actual)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Sciences
Collaborators
The Third Affiliated Hospital of Guangzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Ovarian Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Hormone replacement therapy, placebo transplantation.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Hormone replacement therapy,HUC-MSCs transplantation.
Intervention Type
Biological
Intervention Name(s)
Placebo transplantation
Intervention Description
Intraovarian injection of placebo through vagina under the guidance of ultrasonic.
Intervention Type
Biological
Intervention Name(s)
HUC-MSCs transplantation
Intervention Description
Intraovarian injection of HUC-MSCs through vagina under the guidance of ultrasonic.
Primary Outcome Measure Information:
Title
Number of mature follicle
Description
The number of mature follicles developing was recorded by transvaginal ultrasound scan
Time Frame
Up to 4 months
Secondary Outcome Measure Information:
Title
Follicle-stimulating hormone (FSH) serum level
Description
Serum FSH level was evaluated once a month after surgery
Time Frame
Up to 4 months
Title
Estradiol (E2) serum level
Description
Serum E2 level was evaluated once a month after surgery
Time Frame
Up to 4 months
Title
Anti-Mullerian hormone (AMH) serum level
Description
Serum AMH level was evaluated once a month after surgery
Time Frame
Up to 4 months
Title
Number of antral follicle development
Description
The number of antral follicles developing was recorded by transvaginal ultrasound scan
Time Frame
Up to 4 months
Title
Ovarian volume
Description
The ovarian volume was recorded by transvaginal ultrasound scan
Time Frame
Up to 4 months
Title
Pregnancy rate
Description
The incidence of pregnancy following transfer of embryos produced from oocytes recovered from follicles developing was assessed by Serum Human Chorionic Gonadotropin (HCG) detection.
Time Frame
Up to 12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Long Yan, Doctor
Phone
+86-15650717331
Email
yanlong@ioz.ac.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jianqiao Liu, Doctor
Phone
+86-18928916736
Email
ljq88gz@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongmei Wang, Doctor
Organizational Affiliation
State Key Laboratory of Stem Cell and Reproductive Biology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Zoology, Chinese Academy of Sciences.
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100101
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianqiao Liu, Doctor
Phone
+86-18928916736
Email
ljq88gz@163.com
First Name & Middle Initial & Last Name & Degree
Yixuan Wu, Doctor
Phone
+86-13430202696
Email
87295667@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Women With Primary Ovarian Insufficiency (POI)
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