Clinical Study of in Situ Regeneration of Endometrium

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

345 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-29

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Infertility, Female, of Uterine Origin Endometrial Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CBD-bFGF

Group Type EXPERIMENTAL

CBD-bFGF

Intervention Type DRUG

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

Collagen/BMMNCs

Group Type EXPERIMENTAL

Collagen/BMMNCs

Intervention Type DRUG

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

Estrogen

Group Type EXPERIMENTAL

Estrogen

Intervention Type DRUG

Patients will receive regular estrogen therapy

Interventions

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CBD-bFGF

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

Intervention Type DRUG

Collagen/BMMNCs

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

Intervention Type DRUG

Estrogen

Patients will receive regular estrogen therapy

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No