Clinical trial NCT06234540: a-PRP Intrauterine Instillation in Women With Thin Endometrium
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thin Endometrium
Keywords: PRP, Platelet-rich plasma, IVF/ICSI, Frozen Thaw cycle
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: endometrial thickness
timeFrame: day 12
Secondary outcomes:
measure: endometrial thickness difference between day 8 and day 12
timeFrame: between day 8 and day 12
measure: clinical pregnancy rate
timeFrame: 12 weeks
measure: chemical pregnancy rate
timeFrame: 2 weeks after transfer
measure: miscarriage rate
timeFrame: up to 12 weeks
measure: cancellation rate
timeFrame: day 14
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Sootthinan Pothisan
role: PRINCIPAL_INVESTIGATOR
References: