Clinical Study of in Situ Regeneration of Endometrium

Phase 1

Recruiting

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

• Registration Number: NCT04233892
• Lead Sponsor: Yali Hu

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-18
• Study Start: 2020-04-29
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-28
• Primary Completion: 2022-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 345

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

9. Unable to adhere to the follow-up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Estrogen	Estrogen	-
Collagen/BMMNCs	Collagen/BMMNCs	-
CBD-bFGF	CBD-bFGF	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Pregnancy related complications	24 months	Miscarriage rate, live birth rate, ET cycle cancellation rate,Placenta related complications
Endometrial blood flow	6 months	Endometrial blood flow evaluated by transvaginal sonography
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

Trial Locations

Locations (1)

Nanjing Drum Tower Hospital; 🇨🇳 Nanjing, Jiangsu, China