Infertility, FemaleNCT03592849
The Efficacy and Safety of Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchymal Stem Cells in Infertile Women With Thin Endometrium or Endometrial Scarring
A study testing UC-MSCs therapy in people with Infertility, Female and Endometrium, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
The purpose of the study is to evaluate the safety and effectiveness of the collagen scaffold loaded with umbilical cord derived mesenchymal stem cells (UC-MSCs) in infetile women with thin endometrium or endometrial scarring. Read more about this study
- Who is it for?
- Ages 20 to 42 years, women only
- Conditions the study is for
- Infertility, Female, Endometrium
- What is being tested?
- UC-MSCs therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2018to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to evaluate the safety and effectiveness of the collagen scaffold loaded with umbilical cord derived mesenchymal stem cells (UC-MSCs) in infetile women with thin endometrium or endometrial scarring.
- Conditions
- Infertility, Female, Endometrium
- Being tested
- UC-MSCs therapy
- Keywords
- thin endometrium, infertility
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UC-MSCs therapyProcedure or surgery
Also called collagen scaffold
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.
| Study group | Role | What they receive |
|---|---|---|
| UC-MSCs therapy | Experimental | transplant collagen scaffold loaded with UC-MSCs to treat infertility caused by thin endometrium or endometrial scarring Receives: Procedure: UC-MSCs therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
endometrial thickness
endometrium thickness evaluated by transvaginal sonography during late proliferating phase
Measured: 12 months
Secondary outcomes (3)
ongoing pregnancy rate
the presence of a living intrauterine fetus on TVU at the 12th week of gestation
Measured: 24 months
live birth rate
a live born baby ≥28 weeks of gestation
Measured: 24 months
endometrial blood flow
uterine blood flow evaluated by transvaginal sonography
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start10 Sep 2018
- Primary completion31 Jan 2021
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yali Hu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Yali Hu, MD,PhD, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592849
- Sponsor's protocol ID
- SC201700101
- Status last verified
- Sep 2022
- First submitted
- 9 Jul 2018
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Within six months after the trial complete
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03592849
- Acronym / sponsor ID
- SC201700101
- Conditions
- Infertility, Female, Endometrium
- Keywords
- thin endometrium, infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the safety and effectiveness of the collagen scaffold loaded with umbilical cord derived mesenchymal stem cells (UC-MSCs) in infetile women with thin endometrium or endometrial scarring.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UC-MSCs therapy | Experimental | Procedure: UC-MSCs therapytransplant collagen scaffold loaded with UC-MSCs to treat infertility caused by thin endometrium or endometrial scarring |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UC-MSCs therapyAlso: collagen scaffoldAfter 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. | Procedure or surgery | UC-MSCs therapy |
Primary outcome
endometrial thickness
Time frame: 12 months
endometrium thickness evaluated by transvaginal sonography during late proliferating phase
3 secondary outcomes
ongoing pregnancy rate
Time frame: 24 months
live birth rate
Time frame: 24 months
endometrial blood flow
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No. Within six months after the trial complete
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yali Hu, MD,PhD principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UC-MSCs therapy in people with Infertility, Female and Endometrium, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endometrial thickness (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.