NCT03207412

Brief Summary

This project will investigate the safety and effectiveness of human amniotic epithelial cells in primary ovarian insufficiency patients and provide a new cell therapy against infertility.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

December 22, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

1.5 years

First QC Date

June 30, 2017

Last Update Submit

June 30, 2017

Conditions

Premature Ovarian Failure

Outcome Measures

Primary Outcomes (2)

  • Changes of follicle stimulating hormone(FSH)

    Serum FSH level is evaluated once a month after treatment.

    1 year

  • antral follicle count (AFC)

    the number of primordial egg follicles within the ovary per menstrual cycle

    1 year

Secondary Outcomes (5)

  • Menstrual situation

    1 year

  • Luteinizing Hormone(LH)

    1 year

  • estrogen 2(E2)

    1 year

  • Anti Mullerian Hormone(AMH)

    1 year

  • Ovarian volume

    1 year

Study Arms (2)

Minimally invasive implantation

EXPERIMENTAL

Patients receive minimally invasive implantation, and 200 million hAECs is implanted into bilateral ovarian tissue by Ultrasound-guided puncture.

Biological: hAECsProcedure: Minimally invasive implantation

Intravenous infusion

EXPERIMENTAL

100 million hAECs is administered by intravenous infusion every 30 days, for 3 times.

Biological: hAECs

Interventions

hAECsBIOLOGICAL

human amniotic epithelial cells

Intravenous infusionMinimally invasive implantation
Minimally invasive implantationPROCEDURE

Minimally invasive implantation with ultrasound guidance

Minimally invasive implantation

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of POI, excluding genetic disease caused by patients; POI diagnostic criteria: Patients that \<40 years of age, oligomenorrhea for 4 months,FSH\> 25 IU/L.
  • Have fertility requirements;
  • Agree to sign the designed consent for the study.

You may not qualify if:

  • Breast cancer, ovarian cancer and other cancer/tumor;
  • Contraindications for pregnancy;
  • Coagulation disorder and other abnormal physical conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

  • Chanyu Zhang

    The Second Affiliated Hospital of Chongqing Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chanyu Zhang

CONTACT

86-23-636932961317954623@qq.com

Heng Zou

CONTACT

86-23-63693296zouheng3114@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2017

First Posted

July 2, 2017

Study Start

December 22, 2017

Primary Completion

July 1, 2019

Study Completion

December 31, 2019

Last Updated

July 2, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share