CClinicalTrials.gg
RecruitingNCT06234540PRP(a-PRP)Updated Jan 31, 2024

a-PRP Intrauterine Instillation in Women With Thin Endometrium

An interventional study of PRP and Standard treatment in Thin Endometrium, sponsored by Mahidol University. Recruiting at 1 site in Thailand. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-31.

Sponsored by Mahidol University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 8 months ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Thin Endometrium

Keywords

  • PRP, Platelet-rich plasma, IVF/ICSI, Frozen Thaw cycle
03

In context

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    aPRP 1

    a-PRP intrauterine instillation on Menstruation Cycle Day 8 during frozen thaw cycle procedure

    Procedure: PRP

  • Experimental
    aPRP 2

    a-PRP intrauterine instillation on Menstruation Cycle Day 8 and Day 10 during frozen thaw cycle procedure

    Procedure: PRP

  • Experimental
    Controlled

    Standard treatment of frozen thaw cycle

    Other: Standard treatment

Interventions

  • ProcedurePRP

    a-PRP intrauterine instillation before frozen-thawed embryo transfer cycle

  • OtherStandard treatment

    Standard treatment

06

What researchers measure

Primary outcomes

  1. endometrial thickness

    compare endometrial thickness among 3 group

    Time frame: day 12

Secondary outcomes

  1. endometrial thickness difference between day 8 and day 12

    compare endometrial thickness day 8 and day 12

    Time frame: between day 8 and day 12

  2. clinical pregnancy rate

    seen FHB at 12 weeks

    Time frame: 12 weeks

  3. chemical pregnancy rate

    hcg \> 25 u

    Time frame: 2 weeks after transfer

  4. miscarriage rate

    abortion \< 12 weeks

    Time frame: up to 12 weeks

  5. cancellation rate

    cancel cycle from thin endometrium \< 7 mm

    Time frame: day 14

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06234540
Lead sponsor
Mahidol University
Responsible party
Sootthinan Pothisan (Infertility unit, Obstetric and gynecology department of Siriraj hospital, Mahidol university, Mahidol University) — Principal investigator
First posted
Jan 31, 2024
Start date
Jan 21, 2024
Primary completion
Jan 31, 2025 (estimated)
Completion
May 31, 2025 (estimated)
Last update
Jan 31, 2024

Study contacts

Sootthinan Pothisan
Contact
sootthinan.pot@gmail.com
0894600852
Nichamon Parkpinyo
Contact
ni_nichamon@hotmail.com
0867632251
Sootthinan Pothisan
principal investigator · Mahidol University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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