The Efficacy and Safety of Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchymal Stem Cells in Infertile Women With Thin Endometrium or Endometrial Scarring
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ClinicalTrials.gov Identifier: NCT03592849 |
Recruitment Status :
Completed
First Posted : July 19, 2018
Last Update Posted : September 28, 2022
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Condition or disease | Intervention/treatment | Phase |
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Infertility, Female Endometrium | Procedure: UC-MSCs therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Efficacy and Safety of Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchymal Stem Cells in Infertile Women With Thin Endometrium or Endometrial Scarring |
Actual Study Start Date : | September 10, 2018 |
Actual Primary Completion Date : | January 31, 2021 |
Actual Study Completion Date : | August 31, 2022 |

Arm | Intervention/treatment |
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Experimental: UC-MSCs therapy
transplant collagen scaffold loaded with UC-MSCs to treat infertility caused by thin endometrium or endometrial scarring
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Procedure: UC-MSCs therapy
After history taking, physical examination, ultrasound examination and hysteroscopy examination,infertile women diagnosed with thin endometrium or endometrial scarring will be included in the clinical trial. A collagen scaffold loaded with UC-MSCs will be transplanted into the uterine cavity during hysteroscopy, and participants will receive hormone replacement therapy before and after the treatment. Postoperative observations including ultrasound examination once a month for 3 times and hysteroscopy in the third month after first UC-MSCs therapy. Those whose endometrium is suitable for pregnancy will be recommended attempting conception actively. The next round of cell therapy will be conducted 3 cycles after the first month if the endometrial growth is unsatisfactory.
Other Name: collagen scaffold |
- endometrial thickness [ Time Frame: 12 months ]endometrium thickness evaluated by transvaginal sonography during late proliferating phase
- ongoing pregnancy rate [ Time Frame: 24 months ]the presence of a living intrauterine fetus on TVU at the 12th week of gestation
- live birth rate [ Time Frame: 24 months ]a live born baby ≥28 weeks of gestation
- endometrial blood flow [ Time Frame: 6 months ]uterine blood flow evaluated by transvaginal sonography
- menstrual blood volume [ Time Frame: baseline and 6 month postoperation ]the change of menstrual blood volume after surgery compared with pre-operation
- adverse event rate [ Time Frame: 30 months ]the occurrence of infections、allergies、abdominal pain postoperation

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Ages Eligible for Study: | 20 Years to 42 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Infertile patients with clear fertility desires
- Diagnosed with thin endometrium or endometrial scarring for whom drugs and surgical interventions were ineffective
- 20-42 years old
- Normal ovarian function or with frozen embryos
- Willing to actively cooperate with postoperative follow-up
Exclusion Criteria:
- With abnormal chromosome karyotype
- With other uterine diseases including large intramural myomas, severe endometriosis, severe adenomyosis, severe congenital uterine malformations, endometrial tuberculosis, vaginitis and endometritis
- Systemic diseases: hypertension, diabetes, and so on
- Contraindications to pregnancy
- Contraindications to hormone replacement therapy
- Medical history of pelvic tumors or receiving pelvic radiotherapy
- Involved in other clinical studies
- Unable to adhere to the follow-up

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592849
China, Jiangsu | |
Nanjing Drum Tower Hospital | |
Nanjing, Jiangsu, China, 210008 |
Principal Investigator: | Yali Hu, MD,PhD | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
Responsible Party: | Yali Hu, Professor,Chief Physician of Obstetrics and Gynecology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
ClinicalTrials.gov Identifier: | NCT03592849 |
Other Study ID Numbers: |
SC201700101 |
First Posted: | July 19, 2018 Key Record Dates |
Last Update Posted: | September 28, 2022 |
Last Verified: | September 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Within six months after the trial complete |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
thin endometrium infertility |
Infertility Infertility, Female |