NCT04233892

Brief 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.

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
345

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2020

Longer than P75 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

April 29, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

2.6 years

First QC Date

January 15, 2020

Last Update Submit

September 27, 2022

Conditions

Infertility, Female, of Uterine OriginEndometrial Fibrosis

Keywords

thin endometriuminfertility

Outcome Measures

Primary Outcomes (2)

  • Endometrial thickness

    Endometrial thickness evaluated by transvaginal sonography during late proliferative phase

    6 months

  • Ongoing pregnancy rate

    The presence of a living intrauterine fetus on TVU at the 12th week of gestation

    24 months

Secondary Outcomes (4)

  • Endometrial blood flow

    6 months

  • Pregnancy related complications

    24 months

  • Histological changes of endometrium

    12 months

  • Menstrual blood volume

    6 months

Other Outcomes (1)

  • Adverse event rate

    24 months

Study Arms (3)

CBD-bFGF

EXPERIMENTAL
Drug: CBD-bFGF

Collagen/BMMNCs

EXPERIMENTAL
Drug: Collagen/BMMNCs

Estrogen

EXPERIMENTAL
Drug: Estrogen

Interventions

CBD-bFGFDRUG

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

CBD-bFGF
Collagen/BMMNCsDRUG

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

Collagen/BMMNCs
EstrogenDRUG

Patients will receive regular estrogen therapy

Estrogen

Eligibility Criteria

Age20 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with thin endometrium (4mm≤ EMT \<7mm )or scarred endometrium (scarred area≤70%) which is nonresponsive to estrogen stimulation 2.Infertile patients with clear fertility desires 3.20-42 years old 4.Normal ovarian function or with frozen embryos 5.Willing to participate in follow-up

You may not qualify if:

  • Endometrial thickness \<4mm or scarred endometrial area\>70%
  • Uterine cavity out of shape and the cavity depth\<6.5mm
  • Abnormal chromosome karyotype
  • Uterine diseases including large intramural myomas, severe endometriosis, severe adenomyosis, severe congenital uterine malformations, endometrial tuberculosis, vaginitis and endometritis
  • Systemic diseases: hypertension, diabetes, and so on
  • Contraindications to pregnancy
  • Contraindications to hormone replacement therapy
  • Medical history of pelvic tumors or receiving pelvic radiotherapy 9 .Involved in other clinical studies
  • \. Unable to adhere to the follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

basic fibroblast growth factor-kidney disease domain-collagen-binding domain fusion protein, mouseCollagenEstrogens

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

BiopolymersPolymersMacromolecular SubstancesExtracellular Matrix ProteinsScleroproteinsProteinsAmino Acids, Peptides, and ProteinsHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Yali Hu, MD,PhD

    The Affiliated Drum Tower Hospital of Nanjing University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yali Hu, MD,PhD

CONTACT

025-83106666glyyhuyali@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor，Chief Physician of Obstetrics and Gynecology

Study Record Dates

First Submitted

January 15, 2020

First Posted

January 18, 2020

Study Start

April 29, 2020

Primary Completion

December 1, 2022

Study Completion

December 1, 2024

Last Updated

September 28, 2022

Record last verified: 2022-09

Locations

CN(1)