Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Women With Primary Ovarian Insufficiency (POI)
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|ClinicalTrials.gov Identifier: NCT03033277|
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : January 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Primary Ovarian Insufficiency||Biological: Placebo transplantation Biological: HUC-MSCs transplantation||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Women With Primary Ovarian Insufficiency (POI)|
|Actual Study Start Date :||February 2016|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||July 2018|
Placebo Comparator: Control group
Hormone replacement therapy, placebo transplantation.
Biological: Placebo transplantation
Intraovarian injection of placebo through vagina under the guidance of ultrasonic.
Experimental: Experimental group
Hormone replacement therapy,HUC-MSCs transplantation.
Biological: HUC-MSCs transplantation
Intraovarian injection of HUC-MSCs through vagina under the guidance of ultrasonic.
- Number of mature follicle [ Time Frame: Up to 4 months ]The number of mature follicles developing was recorded by transvaginal ultrasound scan
- Follicle-stimulating hormone (FSH) serum level [ Time Frame: Up to 4 months ]Serum FSH level was evaluated once a month after surgery
- Estradiol (E2) serum level [ Time Frame: Up to 4 months ]Serum E2 level was evaluated once a month after surgery
- Anti-Mullerian hormone (AMH) serum level [ Time Frame: Up to 4 months ]Serum AMH level was evaluated once a month after surgery
- Number of antral follicle development [ Time Frame: Up to 4 months ]The number of antral follicles developing was recorded by transvaginal ultrasound scan
- Ovarian volume [ Time Frame: Up to 4 months ]The ovarian volume was recorded by transvaginal ultrasound scan
- Pregnancy rate [ Time Frame: Up to 12 months ]The incidence of pregnancy following transfer of embryos produced from oocytes recovered from follicles developing was assessed by Serum Human Chorionic Gonadotropin (HCG) detection.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033277
|Contact: Long Yan, Doctorfirstname.lastname@example.org|
|Contact: Jianqiao Liu, Doctoremail@example.com|
|Institute of Zoology, Chinese Academy of Sciences.||Recruiting|
|Beijing, Beijing, China, 100101|
|Contact: Jianqiao Liu, Doctor +86-18928916736 firstname.lastname@example.org|
|Contact: Yixuan Wu, Doctor +86-13430202696 email@example.com|
|Principal Investigator:||Hongmei Wang, Doctor||State Key Laboratory of Stem Cell and Reproductive Biology|