Clinical Study of in Situ Regeneration of Endometrium

Yali Hu

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Infertility, Female, of Uterine Origin; Endometrial Fibrosis

Treatments: Drug: Collagen/BMMNCs; Drug: CBD-bFGF; Drug: Estrogen

Study type: Interventional

Funder types: Other

Identifiers

NCT04233892

SC201900202

Details and patient eligibility

About

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.

Enrollment: 345 estimated patients

Sex: Female

Ages: 20 to 42 years old

Volunteers: No 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

9. Unable to adhere to the follow-up

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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345 participants in 3 patient groups

CBD-bFGF

Experimental group

Treatment:

Drug: CBD-bFGF

Collagen/BMMNCs

Experimental group

Treatment:

Drug: Collagen/BMMNCs

Estrogen

Experimental group

Treatment:

Drug: Estrogen