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Clinical Study of in Situ Regeneration of Endometrium

Primary Purpose

Infertility, Female, of Uterine Origin, Endometrial Fibrosis

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CBD-bFGF
Collagen/BMMNCs
Estrogen
Sponsored by
Yali Hu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female, of Uterine Origin focused on measuring thin endometrium, infertility

Eligibility Criteria

20 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

1.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

Exclusion Criteria:

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

10. Unable to adhere to the follow-up

Sites / Locations

  • Nanjing Drum Tower HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

CBD-bFGF

Collagen/BMMNCs

Estrogen

Arm Description

Outcomes

Primary Outcome Measures

Endometrial thickness
Endometrial thickness evaluated by transvaginal sonography during late proliferative phase
Ongoing pregnancy rate
The presence of a living intrauterine fetus on TVU at the 12th week of gestation

Secondary Outcome Measures

Endometrial blood flow
Endometrial blood flow evaluated by transvaginal sonography
Pregnancy related complications
Miscarriage rate, live birth rate, ET cycle cancellation rate,Placenta related complications
Histological changes of endometrium
Histological changes of the thin endometrium before and after treatment
Menstrual blood volume
The change of menstrual blood volume after treatment compared with pre-treatment

Full Information

First Posted
January 15, 2020
Last Updated
September 27, 2022
Sponsor
Yali Hu
Collaborators
Chinese Academy of Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04233892
Brief Title
Clinical Study of in Situ Regeneration of Endometrium
Official Title
Clinical Study of in Situ Regeneration of Endometrium
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 29, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yali Hu
Collaborators
Chinese Academy of Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female, of Uterine Origin, Endometrial Fibrosis
Keywords
thin endometrium, infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
345 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBD-bFGF
Arm Type
Experimental
Arm Title
Collagen/BMMNCs
Arm Type
Experimental
Arm Title
Estrogen
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CBD-bFGF
Intervention Description
CBD-bFGF will be injected into the endometrium after hysteroscopy under the guidance of ultrasound
Intervention Type
Drug
Intervention Name(s)
Collagen/BMMNCs
Intervention Description
A collagen scaffold loaded with BMMNCs will be transplanted into the uterine cavity after hysteroscopy under the guidance of ultrasound
Intervention Type
Drug
Intervention Name(s)
Estrogen
Intervention Description
Patients will receive regular estrogen therapy
Primary Outcome Measure Information:
Title
Endometrial thickness
Description
Endometrial thickness evaluated by transvaginal sonography during late proliferative phase
Time Frame
6 months
Title
Ongoing pregnancy rate
Description
The presence of a living intrauterine fetus on TVU at the 12th week of gestation
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Endometrial blood flow
Description
Endometrial blood flow evaluated by transvaginal sonography
Time Frame
6 months
Title
Pregnancy related complications
Description
Miscarriage rate, live birth rate, ET cycle cancellation rate,Placenta related complications
Time Frame
24 months
Title
Histological changes of endometrium
Description
Histological changes of the thin endometrium before and after treatment
Time Frame
12 months
Title
Menstrual blood volume
Description
The change of menstrual blood volume after treatment compared with pre-treatment
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Adverse event rate
Description
The occurrence of infections, allergies, abdominal pain, uterine perforation and etc.
Time Frame
24 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1.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 Exclusion Criteria: 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 10. Unable to adhere to the follow-up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yali Hu, MD,PhD
Phone
025-83106666
Ext
11201
Email
glyyhuyali@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yali Hu, MD,PhD
Organizational Affiliation
The Affiliated Drum Tower Hospital of Nanjing University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yali Hu, MD,PhD
Phone
025-83106666
Ext
11201
Email
glyyhuyali@163.com

12. IPD Sharing Statement

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Clinical Study of in Situ Regeneration of Endometrium

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