Infertility, Female, of Uterine OriginPhase 1/2NCT04233892
Clinical Study of in Situ Regeneration of Endometrium
A Phase 1/2 study testing CBD-bFGF, Collagen/BMMNCs and Estrogen in people with Infertility, Female, of Uterine Origin and Endometrial Fibrosis, run by Yali Hu at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 42 years, women only
- Conditions the study is for
- Infertility, Female, of Uterine Origin, Endometrial Fibrosis
- What is being tested?
- CBD-bFGF, Collagen/BMMNCs and Estrogen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2020to Dec 2024
- Phase
- Phase 1/2
- 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
- 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
Who cannot join
- Endometrial thickness <4mm or scarred endometrial area>70%
- Uterine cavity out of shape and the cavity depth<6.5mm
- Abnormal chromosome karyotype
- 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
Show all 9Show fewer
- Contraindications to hormone replacement therapy
- Medical history of pelvic tumors or receiving pelvic radiotherapy 9 .Involved in other clinical studies
- 10. Unable to adhere to the follow-up
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Yali Hu, MD,PhD, 025-83106666 ext. 11201, glyyhuyali@163.com
About this study
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.
- Being tested
- CBD-bFGF, Collagen/BMMNCs, Estrogen
- Keywords
- thin endometrium, infertility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBD-bFGFDrug
CBD-bFGF will be injected into the endometrium after hysteroscopy under the guidance of ultrasound
Collagen/BMMNCsDrug
A collagen scaffold loaded with BMMNCs will be transplanted into the uterine cavity after hysteroscopy under the guidance of ultrasound
EstrogenDrug
Patients will receive regular estrogen therapy
| Study group | Role | What they receive |
|---|---|---|
| CBD-bFGF | Experimental | Not described Receives: Drug: CBD-bFGF |
| Collagen/BMMNCs | Experimental | Not described Receives: Drug: Collagen/BMMNCs |
| Estrogen | Experimental | Not described Receives: Drug: Estrogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial thickness
Endometrial thickness evaluated by transvaginal sonography during late proliferative phase
Measured: 6 months
Ongoing pregnancy rate
The presence of a living intrauterine fetus on TVU at the 12th week of gestation
Measured: 24 months
Secondary outcomes (4)
Endometrial blood flow
Endometrial blood flow evaluated by transvaginal sonography
Measured: 6 months
Pregnancy related complications
Miscarriage rate, live birth rate, ET cycle cancellation rate,Placenta related complications
Measured: 24 months
Histological changes of endometrium
Histological changes of the thin endometrium before and after treatment
Measured: 12 months
Menstrual blood volume
The change of menstrual blood volume after treatment compared with pre-treatment
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 posted18 Jan 2020
- Study start29 Apr 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, Female, of Uterine OriginStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 345 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yali Hu
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Responsible party
- Sponsor-investigator, Yali Hu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Yali Hu, MD,PhD, Principal investigator, The Affiliated Drum Tower Hospital of Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233892
- Sponsor's protocol ID
- SC201900202
- Status last verified
- Sep 2022
- First submitted
- 15 Jan 2020
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Clinical Study of in Situ Regeneration of Endometrium
- ClinicalTrials.gov ID
- NCT04233892
- Acronym / sponsor ID
- SC201900202
- Keywords
- thin endometrium, infertility
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 345 participants (estimated)
- Lead sponsor
- Yali HuUniversity, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Study start
- 29 Apr 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Jan 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBD-bFGF | Experimental | Drug: CBD-bFGF |
| Collagen/BMMNCs | Experimental | Drug: Collagen/BMMNCs |
| Estrogen | Experimental | Drug: Estrogen |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (9 listed)
- Endometrial thickness <4mm or scarred endometrial area>70%
- Uterine cavity out of shape and the cavity depth<6.5mm
- Abnormal chromosome karyotype
- 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
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 |
|---|---|---|
| CBD-bFGFCBD-bFGF will be injected into the endometrium after hysteroscopy under the guidance of ultrasound | Drug | CBD-bFGF |
| Collagen/BMMNCsA collagen scaffold loaded with BMMNCs will be transplanted into the uterine cavity after hysteroscopy under the guidance of ultrasound | Drug | Collagen/BMMNCs |
| EstrogenPatients will receive regular estrogen therapy | Drug | Estrogen |
Primary outcome
Endometrial thickness
Time frame: 6 months
Endometrial thickness evaluated by transvaginal sonography during late proliferative phase
Ongoing pregnancy rate
Time frame: 24 months
The presence of a living intrauterine fetus on TVU at the 12th week of gestation
4 secondary outcomes
Endometrial blood flow
Time frame: 6 months
Pregnancy related complications
Time frame: 24 months
Histological changes of endometrium
Time frame: 12 months
Menstrual blood volume
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
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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 Drum Tower Hospital of Nanjing University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CBD-bFGF, Collagen/BMMNCs and Estrogen in people with Infertility, Female, of Uterine Origin and Endometrial Fibrosis, run by Yali Hu 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 1 inclusion and 9 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: status not confirmed, 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yali Hu, MD,PhD (025-83106666 ext. 11201, glyyhuyali@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometrial thickness (time frame: 6 months). The study lists 2 primary outcomes in all. 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.