NCT03033277

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

1.2 years

First QC Date

January 10, 2017

Last Update Submit

January 24, 2017

Conditions

Primary Ovarian Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Number of mature follicle

    The number of mature follicles developing was recorded by transvaginal ultrasound scan

    Up to 4 months

Secondary Outcomes (6)

  • Follicle-stimulating hormone (FSH) serum level

    Up to 4 months

  • Estradiol (E2) serum level

    Up to 4 months

  • Anti-Mullerian hormone (AMH) serum level

    Up to 4 months

  • Number of antral follicle development

    Up to 4 months

  • Ovarian volume

    Up to 4 months

  • +1 more secondary outcomes

Study Arms (2)

Control group

PLACEBO COMPARATOR

Hormone replacement therapy, placebo transplantation.

Biological: Placebo transplantation

Experimental group

EXPERIMENTAL

Hormone replacement therapy,HUC-MSCs transplantation.

Biological: HUC-MSCs transplantation

Interventions

Placebo transplantationBIOLOGICAL

Intraovarian injection of placebo through vagina under the guidance of ultrasonic.

Control group
HUC-MSCs transplantationBIOLOGICAL

Intraovarian injection of HUC-MSCs through vagina under the guidance of ultrasonic.

Experimental group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed with primary ovarian insufficiency;
  • Women between 20 and 40 years;
  • Have fertility requirements, husband has sperm;
  • Willing to sign the Informed Consent Form.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Zoology, Chinese Academy of Sciences.

Beijing, Beijing Municipality, 100101, China

RECRUITING

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Hongmei Wang, Doctor

    State Key Laboratory of Stem Cell and Reproductive Biology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Long Yan, Doctor

CONTACT

+86-15650717331yanlong@ioz.ac.cn

Jianqiao Liu, Doctor

CONTACT

+86-18928916736ljq88gz@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 26, 2017

Study Start

February 1, 2016

Primary Completion

April 1, 2017

Study Completion

July 1, 2018

Last Updated

January 26, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)