Clinical Study of in Situ Regeneration of Endometrium

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility, Female, of Uterine Origin; Endometrial Fibrosis
• Intervention / Treatment: Drug: CBD-bFGF; Drug: Collagen/BMMNCs; Drug: Estrogen

• Study Type: Interventional
• Enrollment (Anticipated): 345
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Yali Hu, MD,PhD; Phone Number: 11201 025-83106666; Email: glyyhuyali@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Nanjing Drum Tower Hospital
      • Contact: Yali Hu, MD,PhD; Phone Number: 11201 025-83106666; Email: glyyhuyali@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event rate	The occurrence of infections, allergies, abdominal pain, uterine perforation and etc.	24 months

Collaborators and Investigators

• Sponsor: Yali Hu
• Collaborators: Chinese Academy of Sciences
• Investigators: Principal Investigator: Yali Hu, MD,PhD, The Affiliated Drum Tower Hospital of Nanjing University

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: infertility; thin endometrium
• Additional Relevant MeSH Terms: Infertility; Infertility, Female; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens
• Other Study ID Numbers: SC201900202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No