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| Name | Class |
|---|---|
| Chinese Academy of Sciences | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBD-bFGF | Experimental |
| |
| Collagen/BMMNCs | Experimental |
| |
| Estrogen | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBD-bFGF | Drug | CBD-bFGF will be injected into the endometrium after hysteroscopy under the guidance of ultrasound |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event rate | The occurrence of infections, allergies, abdominal pain, uterine perforation and etc. | 24 months |
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:
10. Unable to adhere to the follow-up
female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yali Hu, MD,PhD | Contact | 025-83106666 | 11201 | glyyhuyali@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yali Hu, MD,PhD | The Affiliated Drum Tower Hospital of Nanjing University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Drum Tower Hospital | Recruiting | Nanjing | Jiangsu | 210008 | China |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C000605742 | basic fibroblast growth factor-kidney disease domain-collagen-binding domain fusion protein, mouse |
| D003094 | Collagen |
| D004967 | Estrogens |
| ID | Term |
|---|---|
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D016326 | Extracellular Matrix Proteins |
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| Collagen/BMMNCs | Drug | A collagen scaffold loaded with BMMNCs will be transplanted into the uterine cavity after hysteroscopy under the guidance of ultrasound |
|
| Estrogen | Drug | Patients will receive regular estrogen therapy |
|
| 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 |
| D012596 |
| Scleroproteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |