Clinical Study of in Situ Regeneration of Endometrium

Infertility, Female, of Uterine Origin Clinical Trial

Official title:

Clinical Study of in Situ Regeneration of Endometrium

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04233892
• Other study ID #: SC201900202
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 29, 2020
• Est. completion date: December 2024

Study information

• Verified date: September 2022
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Yali Hu, MD,PhD
• Phone: 025-83106666
• Email: glyyhuyali[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 345
• Est. completion date: December 2024
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Fibrosis
• Infertility
• Infertility, Female
• Infertility, Female, of Uterine Origin

Intervention

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

Locations

Country	Name	City	State
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Yali Hu	Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse event rate	The occurrence of infections, allergies, abdominal pain, uterine perforation and etc.	24 months
Primary	Endometrial thickness	Endometrial thickness evaluated by transvaginal sonography during late proliferative phase	6 months
Primary	Ongoing pregnancy rate	The presence of a living intrauterine fetus on TVU at the 12th week of gestation	24 months
Secondary	Endometrial blood flow	Endometrial blood flow evaluated by transvaginal sonography	6 months
Secondary	Pregnancy related complications	Miscarriage rate, live birth rate, ET cycle cancellation rate,Placenta related complications	24 months
Secondary	Histological changes of endometrium	Histological changes of the thin endometrium before and after treatment	12 months
Secondary	Menstrual blood volume	The change of menstrual blood volume after treatment compared with pre-treatment	6 months