Thin EndometriumPhase 1NCT05455151
Hysteroscopic Injections of Autologous Endometrial Cells and Platelet-rich Plasma in Patients With Thin Endometrium
A Phase 1 study testing Conservative therapy, PRP injection and Injection of PRP after conservative therapy in people with Thin Endometrium, run by Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare at 1 site in Russia.
Trial summary
The investigation is devoted to the study of the effect of the introduction of autologous platelet-rich plasma (PRP) on the thickness of the endometrium. It was found that the injection of PRP and endometrial cells resuspended in PRP into the endometrium of patients with thin endometrium leads to an increase in the… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Thin Endometrium
- What is being tested?
- Conservative therapy, PRP injection and Injection of PRP after conservative therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteRussia
- Study dates
- 1 Oct 2018to 1 Mar 2021
- Phase
- Phase 1
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-40 years
- Normal karyotype
- Normal karyotype of the partner
- Regular ovulatory and menstrual cycle
- Endometrium <7 mm thick as measured at implantation window
- Availability of ≥2 vitrified blastocysts of good quality
- History of implantation failure and/or embryo transfer (ET) cancellation due to insufficient endometrial thickness
Who cannot join
- Pathospermia in partner
- Use of donor gametes
- Premature ovarian failure
- Internal genital anomalies
- Systemic blood diseases and coagulopathy
- Hemoglobin <100 g/L
- Platelets <100×109/L
- Antiplatelet/anticoagulant therapy recipient status
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
Moscow, 117997
About this study
Official title: Hysteroscopic Injections of Autologous Endometrial Cells and Platelet-rich Plasma in Patients With Thin Endometrium - a Pilot Study
The investigation is devoted to the study of the effect of the introduction of autologous platelet-rich plasma (PRP) on the thickness of the endometrium. It was found that the injection of PRP and endometrial cells resuspended in PRP into the endometrium of patients with thin endometrium leads to an increase in the proliferation of endometrial cells, and as a result, to an increase in its thickness.
Read the detailed description
The study enrolled 115 patients with thin endometrium (<7 mm at implantation window) and infertility. The cohort was divided into groups based on the treatment regimen.
Group 1 (the control, n=30) underwent conservative therapy. Group 2 (n=42) received intraendometrial injections of autologous PRP instead of the conservative therapy. Group 3 (n=38) received identical injections after conservative therapy. Group 4 (n=5) received injections of the minimally manipulated autologous endometrial cells suspended in autologous PRP.
Injections of PRP and endometrial cells suspended in autologous PRP into basal layer of endometrium facilitate the reconstitution by enhancing cell proliferation and angiogenesis.
- Conditions
- Thin Endometrium
- Being tested
- Conservative therapy, PRP injection, Injection of PRP after conservative therapy, Injection of PRP with endometrial cells
- Keywords
- platelet-rich plasma, infertility, endometrial cells
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative therapyProcedure or surgery
Conservative therapy to which the patients were subjected was the effect of an electrical impulse
PRP injectionBiological
This intervention consisted of injecting platelet-rich plasma (PRP) into the endometrium
Injection of PRP after conservative therapyBiological
This intervention consisted of conducting conservative therapy with an electrical impulse and then injecting PRP inside the endometrium
Injection of PRP with endometrial cellsBiological
This intervention consisted of injecting endometrial cells suspended in prp
| Study group | Role | What they receive |
|---|---|---|
| Conservative therapy | Active comparator | This is Group 1, whose patients received electrical impulse therapy using a BTL-4000 Premium G device (BTL Medical Technologies, Czech Republic) starting from day 5-7 of menstrual cycle for 10-12 days daily. Receives: Procedure: Conservative therapy |
| PRP injection | Experimental | This is Group 2, whose patients received single intraendometrial injections of autologous PRP during proliferative phase (day 6-9) of menstrual cycle. Receives: Biological: PRP injection |
| Injection of PRP after conservative therapy | Experimental | This is Group 3, whose patients received electrical impulse therapy identically with Group 1 during the first menstrual cycle. In the second cycle, the patients received autologous PRP injections identically with Group 2. Receives: Biological: Injection of PRP after conservative therapy |
| Injection of PRP with endometrial cells | Experimental | This is Group 4, whose patients received single intraendometrial injections of the minimally manipulated autologous endometrial cells suspended in autologous PRP during proliferative phase (day 6-9) of menstrual cycle. Receives: Biological: Injection of PRP with endometrial cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in endometrial thickness after treatment compared with control.
Ultrasonography measurements of endometrial thickness before and after the therapy and compare the thickness. Endometrial thickness measured in mm.
Measured: Baseline and 2 month
The Doppler-assisted detection of the uterine spiral arteries
The number of identified vessels is counted and the percentage of detection frequency is calculated accordingly, adjusted for the McNemar's binomial test. Compare the rates of visualization of the uterine spiral arteries after therapy in all groups of patients.
Measured: 1 month
Study of the effect of therapy on the onset of pregnancy
Investigation of the rates of clinical pregnancies and live births in all groups. After therapy, the number of clinical pregnancy and the number of live births were calculated.
Measured: 9 months
The content of growth factor in autologous PRP
Investigation of the content of platelet-derived growth factor-BB (PDGF-BB) and vascular endothelial growth factor (VEGF) in autologous PRP. Relative levels of PDGF-BB and VEGF are normalized to the total protein content.
Measured: 3 month
Phenotyping of cells isolated from endometrial biopsies
Investigation of cellular composition in endometrial biopsy. The percentage of cells positive for markers of mesenzymal stromal cells, epithelial and endothelial cells, lymphocytes is calculated and the determination of the phenotype of cells in endometrial biopsy.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 Oct 2018
- Primary completion11 Jan 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thin EndometriumStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients were divided into 4 groups depending on the substances introduced into the basal layer of the endometrium. Group 1 underwent conservative therapy. Group 2 received intraendometrial injections of autologous PRP instead of the conservative therapy. Group 3 received identical injections after conservative therapy. Group 4 received injections of the minimally manipulated autologous endometrial cells suspended in autologous PRP.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
- Sponsor type
- Other government
- Collaborators
- Sechenov University
- Responsible party
- Sponsor
- Investigators
- Inna Apolikhina, MD, Study director, FSBI "National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov" Ministry of Healthcare of the Russian FederationZulfiia Efendieva, PhD, Principal investigator, FSBI "National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov" Ministry of Healthcare of the Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455151
- Sponsor's protocol ID
- №10-18/11.2018
- Status last verified
- Jun 2022
- First submitted
- 28 Jun 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hysteroscopic Injections of Autologous Endometrial Cells and Platelet-rich Plasma in Patients With Thin Endometrium - a Pilot Study
- ClinicalTrials.gov ID
- NCT05455151
- Acronym / sponsor ID
- №10-18/11.2018
- Conditions
- Thin Endometrium
- Keywords
- platelet-rich plasma, infertility, endometrial cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of HealthcareOther government
- Collaborators
- Sechenov University
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 11 Jan 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 13 Jul 2022 (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 investigation is devoted to the study of the effect of the introduction of autologous platelet-rich plasma (PRP) on the thickness of the endometrium. It was found that the injection of PRP and endometrial cells resuspended in PRP into the endometrium of patients with thin endometrium leads to an increase in the proliferation of endometrial cells, and as a result, to an increase in its thickness.
Detailed description
The study enrolled 115 patients with thin endometrium (<7 mm at implantation window) and infertility. The cohort was divided into groups based on the treatment regimen.
Group 1 (the control, n=30) underwent conservative therapy. Group 2 (n=42) received intraendometrial injections of autologous PRP instead of the conservative therapy. Group 3 (n=38) received identical injections after conservative therapy. Group 4 (n=5) received injections of the minimally manipulated autologous endometrial cells suspended in autologous PRP.
Injections of PRP and endometrial cells suspended in autologous PRP into basal layer of endometrium facilitate the reconstitution by enhancing cell proliferation and angiogenesis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- The patients were divided into 4 groups depending on the substances introduced into the basal layer of the endometrium. Group 1 underwent conservative therapy. Group 2 received intraendometrial injections of autologous PRP instead of the conservative therapy. Group 3 received identical injections after conservative therapy. Group 4 received injections of the minimally manipulated autologous endometrial cells suspended in autologous PRP.
| Arm | Type | Receives |
|---|---|---|
| Conservative therapy | Active comparator | Procedure: Conservative therapyThis is Group 1, whose patients received electrical impulse therapy using a BTL-4000 Premium G device (BTL Medical Technologies, Czech Republic) starting from day 5-7 of menstrual cycle for 10-12 days daily. |
| PRP injection | Experimental | Biological: PRP injectionThis is Group 2, whose patients received single intraendometrial injections of autologous PRP during proliferative phase (day 6-9) of menstrual cycle. |
| Injection of PRP after conservative therapy | Experimental | Biological: Injection of PRP after conservative therapyThis is Group 3, whose patients received electrical impulse therapy identically with Group 1 during the first menstrual cycle. In the second cycle, the patients received autologous PRP injections identically with Group 2. |
| Injection of PRP with endometrial cells | Experimental | Biological: Injection of PRP with endometrial cellsThis is Group 4, whose patients received single intraendometrial injections of the minimally manipulated autologous endometrial cells suspended in autologous PRP during proliferative phase (day 6-9) of menstrual cycle. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18-40 years
- Normal karyotype
- Normal karyotype of the partner
- Regular ovulatory and menstrual cycle
- Endometrium <7 mm thick as measured at implantation window
Key exclusion criteria (8 listed)
- Pathospermia in partner
- Use of donor gametes
- Premature ovarian failure
- Internal genital anomalies
- Systemic blood diseases and coagulopathy
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 |
|---|---|---|
| Conservative therapyConservative therapy to which the patients were subjected was the effect of an electrical impulse | Procedure or surgery | Conservative therapy |
| PRP injectionThis intervention consisted of injecting platelet-rich plasma (PRP) into the endometrium | Biological | PRP injection |
| Injection of PRP after conservative therapyThis intervention consisted of conducting conservative therapy with an electrical impulse and then injecting PRP inside the endometrium | Biological | Injection of PRP after conservative therapy |
| Injection of PRP with endometrial cellsThis intervention consisted of injecting endometrial cells suspended in prp | Biological | Injection of PRP with endometrial cells |
Primary outcome
Change in endometrial thickness after treatment compared with control.
Time frame: Baseline and 2 month
Ultrasonography measurements of endometrial thickness before and after the therapy and compare the thickness. Endometrial thickness measured in mm.
The Doppler-assisted detection of the uterine spiral arteries
Time frame: 1 month
The number of identified vessels is counted and the percentage of detection frequency is calculated accordingly, adjusted for the McNemar's binomial test. Compare the rates of visualization of the uterine spiral arteries after therapy in all groups of patients.
Study of the effect of therapy on the onset of pregnancy
Time frame: 9 months
Investigation of the rates of clinical pregnancies and live births in all groups. After therapy, the number of clinical pregnancy and the number of live births were calculated.
The content of growth factor in autologous PRP
Time frame: 3 month
Investigation of the content of platelet-derived growth factor-BB (PDGF-BB) and vascular endothelial growth factor (VEGF) in autologous PRP. Relative levels of PDGF-BB and VEGF are normalized to the total protein content.
Phenotyping of cells isolated from endometrial biopsies
Time frame: 3 month
Investigation of cellular composition in endometrial biopsy. The percentage of cells positive for markers of mesenzymal stromal cells, epithelial and endothelial cells, lymphocytes is calculated and the determination of the phenotype of cells in endometrial biopsy.
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 13 Jul 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.
Inna Apolikhina, MD study director
FSBI "National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov" Ministry of Healthcare of the Russian Federation
Zulfiia Efendieva, PhD principal investigator
FSBI "National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov" Ministry of Healthcare of the Russian Federation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Conservative therapy, PRP injection and Injection of PRP after conservative therapy in people with Thin Endometrium, run by Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare at 1 site in Russia.
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 7 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 13 Jul 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 Russia. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in endometrial thickness after treatment compared with control. (time frame: Baseline and 2 month). The study lists 5 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 13 Jul 2022; AzTrials last refreshed its copy on 8 Nov 2026.