Clinical Study of in Situ Regeneration of Endometrium

Sponsor

Yali Hu (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04233892

Collaborator

Chinese Academy of Sciences (Other)

345

Enrollment

Location

Arms

43.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female, of Uterine Origin Endometrial Fibrosis	Drug: CBD-bFGF Drug: Collagen/BMMNCs Drug: Estrogen	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

345 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Clinical Study of in Situ Regeneration of Endometrium

Actual Study Start Date :

Apr 29, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CBD-bFGF	Drug: CBD-bFGF CBD-bFGF will be injected into the endometrium after hysteroscopy under the guidance of ultrasound
Experimental: Collagen/BMMNCs	Drug: Collagen/BMMNCs A collagen scaffold loaded with BMMNCs will be transplanted into the uterine cavity after hysteroscopy under the guidance of ultrasound
Experimental: Estrogen	Drug: Estrogen Patients will receive regular estrogen therapy

Arm

Intervention/Treatment

Experimental: CBD-bFGF

Drug: CBD-bFGF

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

Experimental: Collagen/BMMNCs

Drug: Collagen/BMMNCs

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

Experimental: Estrogen

Drug: Estrogen

Patients will receive regular estrogen therapy

Outcome Measures

Primary Outcome Measures

Endometrial thickness [6 months]
Endometrial thickness evaluated by transvaginal sonography during late proliferative phase
Ongoing pregnancy rate [24 months]
The presence of a living intrauterine fetus on TVU at the 12th week of gestation

Secondary Outcome Measures

Endometrial blood flow [6 months]
Endometrial blood flow evaluated by transvaginal sonography
Pregnancy related complications [24 months]
Miscarriage rate, live birth rate, ET cycle cancellation rate,Placenta related complications
Histological changes of endometrium [12 months]
Histological changes of the thin endometrium before and after treatment
Menstrual blood volume [6 months]
The change of menstrual blood volume after treatment compared with pre-treatment

Other Outcome Measures

Adverse event rate [24 months]
The occurrence of infections, allergies, abdominal pain, uterine perforation and etc.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 42 Years

Sexes Eligible for Study:

Female

Accepts 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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanjing Drum Tower Hospital	Nanjing	Jiangsu	China	210008

Sponsors and Collaborators

Yali Hu
Chinese Academy of Sciences

Investigators

Principal Investigator: Yali Hu, MD,PhD, The Affiliated Drum Tower Hospital of Nanjing University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yali Hu, Professor，Chief Physician of Obstetrics and Gynecology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

ClinicalTrials.gov Identifier:

NCT04233892

Other Study ID Numbers:

SC201900202

First Posted:

Jan 18, 2020

Last Update Posted:

Sep 1, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yali Hu, Professor，Chief Physician of Obstetrics and Gynecology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

thin endometrium

infertility

Additional relevant MeSH terms:

Infertility

Infertility, Female

Estrogens

Study Results

No Results Posted as of Sep 1, 2021