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Clinical Study of in Situ Regeneration of Endometrium

NCT04233892 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 345

Last updated 2022-09-28

No results posted yet for this study

Summary

Thin endometrium will lead to hypomenorrhea，infertility and recurrent pregnancy loss and there are few effective methods to increase the endometrial thickness and improve the fertility outcomes. Patients with thin endometrium will be divided into three groups and receive estrogen therapy, stem cell therapy and growth factor therapy respectively. This randomized controlled clinical study is carried out to explore the optimal treatment method and best indications for thin endometrium.

Conditions

  • Infertility, Female, of Uterine Origin
  • Endometrial Fibrosis

Interventions

DRUG

CBD-bFGF

CBD-bFGF will be injected into the endometrium after hysteroscopy under the guidance of ultrasound

DRUG

Collagen/BMMNCs

A collagen scaffold loaded with BMMNCs will be transplanted into the uterine cavity after hysteroscopy under the guidance of ultrasound

DRUG

Estrogen

Patients will receive regular estrogen therapy

Sponsors & Collaborators

  • Chinese Academy of Sciences

    collaborator OTHER_GOV

  • Yali Hu

    lead OTHER

Principal Investigators

  • Yali Hu, MD,PhD · The Affiliated Drum Tower Hospital of Nanjing University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-29
Primary Completion
2022-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04233892 on ClinicalTrials.gov