Thin EndometriumPRP(a-PRP)NCT06234540
a-PRP Intrauterine Instillation in Women With Thin Endometrium
A study testing PRP and Standard treatment in people with Thin Endometrium, run by Mahidol University at 1 site in Thailand.
Trial summary
This study sought to compare the endometrial thickness among infertile women with a history of thin endometrium together with previous cancellation from IVF/ICSI inspection of intrauterine instillation of autologous-PRP or no treatment before embryo transfer in the frozen-thaw cycles. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Thin Endometrium
- What is being tested?
- PRP and Standard treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteThailand
- Study dates
- 21 Jan 2024to 31 May 2025
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who will undergo frozen embryo transfer (Frozen-thawed cycle)
- Age above 18 years
- Thai nationality
- Have a history of cycle cancellation due to a thin endometrium <7 mm. after standard hormonal treatmetn
Who cannot join
- medical conditions eg. Platelet dysfunction , vWD
- thrombocytopenia <100,000 cell/mm3
- Receive antiplatelet therapy
- Uterine anomaly, cavity distortion eg submucous myoma uteri, uterine synergia, endometrial polyp
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Siriraj Hospital
Bangkok Noi, Bangkok, 10700
Sootthinan Pothisan, 0894600852, sootthinan.pot@gmail.com
Nichamon Parkpinyo, 0867632251, ni_nichamon@hotmail.com
About this study
Official title: Effect of Autologous Platelet Rich Plasma(a-PRP) Intrauterine Instillation in Infertile Women With Thin Endometrium in Frozen-thawed Embryo Transfer Cycle: a Randomized Controlled Study
This study sought to compare the endometrial thickness among infertile women with a history of thin endometrium together with previous cancellation from IVF/ICSI inspection of intrauterine instillation of autologous-PRP or no treatment before embryo transfer in the frozen-thaw cycles.
Read the detailed description
At present, infertility is a major problem in Thailand. As a result, the Ministry of Public Health has to push the guidelines for using reproductive technology to play a role in increasing the population in the country. The most well-known use of reproductive technology is In vitro fertilization (IVF) has a success rate of approximately 35-40%. There are many factors affecting the success of pregnancy, one of which is the thickness of the uterine cavity.
An endometrial thickness of less than 7 mm in the middle of the menstrual cycle is called endometrial lining. Thin endometrium, which can affect pregnancy Both the rate of embryo implantation pregnancy rate and miscarriage rates In the process of IVF In practice, the appropriate and popular thickness of the uterine cavity for embryo transfer is based on a thickness greater than equal to 7 mm. This is because many studies have found that the thickness of the uterine cavity At 8 mm, this can significantly increase pregnancy rates.
Platelet Rich Plasma (PRP) is another new treatment approach. There is information and research results that show that PRP can increase the thickness of the uterine cavity. and found to help increase blood flowing to the area The uterine wall in infertile women who have a thin uterine cavity. According to a study by Chang et al., in 2015, PRP was used to increase the thickness of the uterine cavity. Found that it can increase the thickness of the uterine cavity. It also tends to increase the pregnancy rate. This is likely caused by Helping increase the number of cells cell regeneration and repair of worn out parts of body cells Through the main mechanism of PRP is adding substances that stimulate cell growth (Growth factors) and proteins that are signals between cells (Cytokines). Someone has studied and compared the levels of substances that stimulate cell growth in PRP. Compared with lymph (plasma), it was found that the levels of cell growth stimulants in PRP were 2.4-2.8 times higher than those in lymph, with statistical significance.
Moreover, the process of preparing PRP is not complicated and the prepared ingredients do not cause any harmful side effects to the body. Therefore, it can be seen from various sectors and various studies that PRP has been used to accelerate growth, such as treating hair loss or baldness. Reducing inflammation or pain in various joints Or even use it to restore beauty, nourish the skin, etc.
In this study The authors therefore attempt to demonstrate the benefits of PRP that may promote endometrial thickening in women with endometrial hyperplasia in order to achieve appropriate endometrial thickness. Received embryo transfer in the next embryo freezing cycle. In addition, in Thailand there has never been a study of increasing the thickness of the uterine cavity with PRP injections before. Therefore, the creators expect that this method may be a method that can increase the implantation rate. Embryo or clinical pregnancy rate Including reducing the rate of embryo implantation cancellations to reduce anxiety for infertile couples in Thailand.
- Conditions
- Thin Endometrium
- Being tested
- PRP, Standard treatment
- Keywords
- PRP, Platelet-rich plasma, IVF/ICSI, Frozen Thaw cycle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPProcedure or surgery
a-PRP intrauterine instillation before frozen-thawed embryo transfer cycle
Standard treatmentOther
Standard treatment
| Study group | Role | What they receive |
|---|---|---|
| aPRP 1 | Experimental | a-PRP intrauterine instillation on Menstruation Cycle Day 8 during frozen thaw cycle procedure Receives: Procedure: PRP |
| aPRP 2 | Experimental | a-PRP intrauterine instillation on Menstruation Cycle Day 8 and Day 10 during frozen thaw cycle procedure Receives: Procedure: PRP |
| Controlled | Experimental | Standard treatment of frozen thaw cycle Receives: Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
endometrial thickness
compare endometrial thickness among 3 group
Measured: day 12
Secondary outcomes (5)
endometrial thickness difference between day 8 and day 12
compare endometrial thickness day 8 and day 12
Measured: between day 8 and day 12
clinical pregnancy rate
seen FHB at 12 weeks
Measured: 12 weeks
chemical pregnancy rate
hcg > 25 u
Measured: 2 weeks after transfer
miscarriage rate
abortion < 12 weeks
Measured: up to 12 weeks
cancellation rate
cancel cycle from thin endometrium < 7 mm
Measured: day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start21 Jan 2024
- Primary completion31 Jan 2025 (estimated)
- Study completion31 May 2025 (estimated)
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.
- More trials run by Mahidol UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sootthinan Pothisan, Mahidol University
- Investigators
- Sootthinan Pothisan, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234540
- Sponsor's protocol ID
- 853/2566(IRB4)
- Other IDs
- WHO
- Acronym
- PRP(a-PRP)
- Status last verified
- Jan 2024
- First submitted
- 23 Jan 2024
- Last updated
- 31 Jan 2024
- 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 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Autologous Platelet Rich Plasma(a-PRP) Intrauterine Instillation in Infertile Women With Thin Endometrium in Frozen-thawed Embryo Transfer Cycle: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06234540
- Acronym / sponsor ID
- PRP(a-PRP) / 853/2566(IRB4)
- Conditions
- Thin Endometrium
- Keywords
- PRP, Platelet-rich plasma, IVF/ICSI, Frozen Thaw cycle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 21 Jan 2024 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 31 Jan 2024 (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.
This study sought to compare the endometrial thickness among infertile women with a history of thin endometrium together with previous cancellation from IVF/ICSI inspection of intrauterine instillation of autologous-PRP or no treatment before embryo transfer in the frozen-thaw cycles.
Detailed description
At present, infertility is a major problem in Thailand. As a result, the Ministry of Public Health has to push the guidelines for using reproductive technology to play a role in increasing the population in the country. The most well-known use of reproductive technology is In vitro fertilization (IVF) has a success rate of approximately 35-40%. There are many factors affecting the success of pregnancy, one of which is the thickness of the uterine cavity.
An endometrial thickness of less than 7 mm in the middle of the menstrual cycle is called endometrial lining. Thin endometrium, which can affect pregnancy Both the rate of embryo implantation pregnancy rate and miscarriage rates In the process of IVF In practice, the appropriate and popular thickness of the uterine cavity for embryo transfer is based on a thickness greater than equal to 7 mm. This is because many studies have found that the thickness of the uterine cavity At 8 mm, this can significantly increase pregnancy rates.
Platelet Rich Plasma (PRP) is another new treatment approach. There is information and research results that show that PRP can increase the thickness of the uterine cavity. and found to help increase blood flowing to the area The uterine wall in infertile women who have a thin uterine cavity. According to a study by Chang et al., in 2015, PRP was used to increase the thickness of the uterine cavity. Found that it can increase the thickness of the uterine cavity. It also tends to increase the pregnancy rate. This is likely caused by Helping increase the number of cells cell regeneration and repair of worn out parts of body cells Through the main mechanism of PRP is adding substances that stimulate cell growth (Growth factors) and proteins that are signals between cells (Cytokines). Someone has studied and compared the levels of substances that stimulate cell growth in PRP. Compared with lymph (plasma), it was found that the levels of cell growth stimulants in PRP were 2.4-2.8 times higher than those in lymph, with statistical significance.
Moreover, the process of preparing PRP is not complicated and the prepared ingredients do not cause any harmful side effects to the body. Therefore, it can be seen from various sectors and various studies that PRP has been used to accelerate growth, such as treating hair loss or baldness. Reducing inflammation or pain in various joints Or even use it to restore beauty, nourish the skin, etc.
In this study The authors therefore attempt to demonstrate the benefits of PRP that may promote endometrial thickening in women with endometrial hyperplasia in order to achieve appropriate endometrial thickness. Received embryo transfer in the next embryo freezing cycle. In addition, in Thailand there has never been a study of increasing the thickness of the uterine cavity with PRP injections before. Therefore, the creators expect that this method may be a method that can increase the implantation rate. Embryo or clinical pregnancy rate Including reducing the rate of embryo implantation cancellations to reduce anxiety for infertile couples in Thailand.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| aPRP 1 | Experimental | Procedure: PRPa-PRP intrauterine instillation on Menstruation Cycle Day 8 during frozen thaw cycle procedure |
| aPRP 2 | Experimental | Procedure: PRPa-PRP intrauterine instillation on Menstruation Cycle Day 8 and Day 10 during frozen thaw cycle procedure |
| Controlled | Experimental | Other: Standard treatmentStandard treatment of frozen thaw cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who will undergo frozen embryo transfer (Frozen-thawed cycle)
- Age above 18 years
- Thai nationality
- Have a history of cycle cancellation due to a thin endometrium <7 mm. after standard hormonal treatmetn
Key exclusion criteria (4 listed)
- medical conditions eg. Platelet dysfunction , vWD
- thrombocytopenia <100,000 cell/mm3
- Receive antiplatelet therapy
- Uterine anomaly, cavity distortion eg submucous myoma uteri, uterine synergia, endometrial polyp
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 |
|---|---|---|
| PRPa-PRP intrauterine instillation before frozen-thawed embryo transfer cycle | Procedure or surgery | aPRP 1, aPRP 2 |
| Standard treatmentStandard treatment | Other | Controlled |
Primary outcome
endometrial thickness
Time frame: day 12
compare endometrial thickness among 3 group
5 secondary outcomes
endometrial thickness difference between day 8 and day 12
Time frame: between day 8 and day 12
clinical pregnancy rate
Time frame: 12 weeks
chemical pregnancy rate
Time frame: 2 weeks after transfer
miscarriage rate
Time frame: up to 12 weeks
cancellation rate
Time frame: day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
Related trials for Thin Endometrium
Recruiting
CURENDO (Cord-blood Uterine Regeneration Endometrium): Platelet-rich Plasma Therapy Derived From Umbilical Cord Blood for the Treatment of Endometrial Pathologies (Asherman Syndrome / Endometrial Atrophy / Thin Endometrium)
Asherman Syndrome
Not yet recruitingPhase 3
Intrauterine G-CSF Infusion for Thin Endometrium
Thin Endometrium, Female Infertility
Not yet recruiting
Experimental Study on the Use of Intrauterine Infusion of Autologous Platelet-rich Plasma (PRGF-IUI) in Patients With Recurrent Implantation Failure and/or Refractory Thin Endometrium
Recurrent Implantation Failure, Endometrial Receptivity Disorders
Recruiting
A Randomized Controlled Study on the Effect of MRJPs on Improving Ovarian Function and Endometrial Receptivity
Diminished Ovarian Reserve (DOR), Thin Endometrium
RecruitingPhase 1
AD-SVF Therapy for Refractory Endometrial Infertility
Endometrium; Atrophy, Intrauterine Synechiae
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.
Sootthinan Pothisan principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP and Standard treatment in people with Thin Endometrium, run by Mahidol University at 1 site in Thailand.
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 4 inclusion and 4 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 31 Jan 2024. 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sootthinan Pothisan (0894600852, sootthinan.pot@gmail.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: day 12). 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 31 Jan 2024.