Recurrent Implantation FailurePMA_PREPAIRENCT07455773
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
A study testing Intrauterine Platelet-Rich Plasma (PRP) Infusion and Hormone Replacement Therapy (HRT) in people with Recurrent Implantation Failure and Endometrial Receptivity Disorders, run by Azienda Sanitaria Locale di Asti.
Trial summary
Endometrial receptivity is a key determinant of success in assisted reproductive technology (ART). A significant proportion of patients experience repeated implantation failure despite euploid embryos and adequate laboratory conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Recurrent Implantation Failure, Endometrial Receptivity Disorders, Embryo Implantation
- What is being tested?
- Intrauterine Platelet-Rich Plasma (PRP) Infusion and Hormone Replacement Therapy (HRT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged 18 to 45 years
- Body mass index (BMI) between 18 and 30 kg/m
- Undergoing assisted reproductive technology (ART) cycle with hormone replacement therapy
- Endometrial thickness < 7 mm after at least 10 days of hormone replacement therapy
- History of at least one failed embryo transfer
- Normal hematologic and biochemical laboratory results
- Ability to understand and sign written informed consent
Who cannot join
- Endometrial hyperplasia or uterine malignancy
- Active pelvic inflammatory disease or untreated sexually transmitted infection
- Coagulation disorders or platelet abnormalities
- Thrombocytopenia (<100,000/mm³)
- Chronic anticoagulant therapy
- Active systemic infection or immunodeficiency
- Contraindications to intrauterine procedures
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
MANUELA CANICATTI', Clinical Trials Coordinator contact
About this study
Official title: PMA_PREPAIRE STUDY: 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.
Endometrial receptivity is a key determinant of success in assisted reproductive technology (ART). A significant proportion of patients experience repeated implantation failure despite euploid embryos and adequate laboratory conditions. Thin endometrium, often defined as ultrasound-measured thickness <7 mm at embryo transfer, is frequently refractory to estrogen therapy and associated with low implantation and clinical pregnancy rates.
Platelet-Rich Plasma (PRP), obtained from autologous blood by double centrifugation, is rich in growth factors capable of stimulating cell proliferation, angiogenesis, and tissue regeneration, suggesting potential benefits for endometrial function. Preliminary studies indicate improved endometrial thickness and reproductive outcomes following intrauterine PRP infusion, but standardized protocols and systematic data are lacking.
Read more
The PMA_PREPAIRE study is a prospective, single-center, controlled, non-randomized interventional clinical trial conducted at the Reproductive Medicine Center of Cardinal Massaia Hospital, Asti. The study aims to evaluate the efficacy and safety of intrauterine infusion of autologous platelet-rich plasma (PRP), in association with hormone replacement therapy (HRT), in improving endometrial receptivity and reproductive outcomes in women with thin or refractory endometrium. The study includes a prospective control group treated with standard HRT alone.
Eligible women will be treated with standard clinical care, with PRP infusion offered to those with insufficient response to HRT. Inclusion criteria include age 18-45, BMI 18-30 kg/m², history of ≥1 failed embryo transfer, EMT <5 mm after ≥10 days of HRT, and normal routine lab tests. Exclusion criteria include endometrial disease, recent gynecological infection, and systemic conditions such as thrombocytopenia or coagulopathies.
Procedures include standard HRT from cycle days 1-2, serial ultrasound monitoring of endometrial thickness from days 6-8, intrauterine PRP infusion if EMT ≤7 mm (up to three infusions per cycle), embryo transfer once EMT ≥7 mm, and follow-up through pregnancy testing and confirmatory ultrasound.
Collected data will be analyzed using descriptive statistics, paired and unpaired comparative analyses, and multivariate logistic regression models to evaluate predictors of treatment response and reproductive outcomes (significance level p < 0.05).
A sample size of 34 patients per group was estimated to detect a 1.5 mm difference in endometrial thickness (EMT) with 90% statistical power. Considering an anticipated dropout rate of 15%, a total of 40 patients per group will be enrolled.
The study includes:
an intervention group consisting of 40 patients treated with HRT plus intrauterine PRP infusion; a prospective control group consisting of 40 patients with refractory thin endometrium treated with standard HRT alone, without PRP.
Read the detailed description
Endometrial receptivity plays a central role in the implantation process and the success of assisted reproductive technologies (ART). A receptive endometrium undergoes synchronized cellular proliferation, vascularization, stromal decidualization, and expression of specific cytokines and adhesion molecules at the time of embryo transfer. Thin endometrium, commonly defined as a transvaginal ultrasound-measured thickness of less than 7 mm, is frequently encountered in patients undergoing ART and is associated with lower implantation and clinical pregnancy rates.
Refractoriness of the endometrium to standard hormone replacement therapy (HRT) represents a persistent clinical challenge. Despite optimization of estrogen administration routes and doses, a significant subset of patients fails to achieve adequate thickness and functional receptivity. These patients often experience repeated implantation failure (RIF), defined by multiple unsuccessful implantation attempts despite transfer of high-quality embryos.
Platelet-Rich Plasma (PRP) is an autologous biological product obtained from peripheral blood through differential centrifugation. PRP contains a high concentration of platelets, which store a complex milieu of growth factors and cytokines, including platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-β), vascular endothelial growth factor (VEGF), and epidermal growth factor (EGF). These bioactive molecules have mitogenic, angiogenic, and chemotactic properties that facilitate tissue repair and regeneration. The theoretical rationale for PRP application in reproductive medicine is based on its potential to augment stromal proliferation, enhance microvascular growth, and improve the structural and functional characteristics of the endometrium.
Preliminary evidence from observational and interventional clinical studies suggests that intrauterine infusion of autologous PRP may be associated with increased endometrial thickness, improved uterine hemodynamics, and enhanced reproductive outcomes, including implantation and clinical pregnancy rates. In retrospective cohort analyses, patients treated with PRP showed significant improvements in endometrial parameters and pregnancy outcomes compared to conventional therapy. Although variations exist in study designs, inclusion criteria, and infusion protocols, a recurring finding is the promising therapeutic effect of PRP on endometrial receptivity.
Despite these encouraging data, the current literature also highlights the lack of standardized protocols and high-quality, large-scale randomized controlled trials. Systematic reviews and meta-analyses have underscored the need for well-designed clinical trials to establish the reproducibility and clinical validity of PRP therapy in this context. Some guidelines and expert groups note that while the biological rationale is strong, PRP use cannot yet be universally recommended without further evidence from rigorously controlled studies.
The PMA_PREPAIRE study was designed to address the current lack of robust clinical evidence regarding the use of intrauterine autologous platelet-rich plasma (PRP) in patients with refractory thin endometrium undergoing assisted reproductive technology (ART) treatments.
The study prospectively evaluates the efficacy and safety of intrauterine PRP infusion in a controlled clinical setting, comparing reproductive and endometrial outcomes between patients treated with HRT plus PRP and a prospective control group receiving standard HRT alone.
The trial design aims to combine real-world clinical applicability with methodological rigor through:
- predefined inclusion and exclusion criteria; standardized PRP preparation and infusion procedures; prospective and structured data collection; controlled comparison between study groups.
Primary and secondary outcomes include:
- changes in endometrial thickness (EMT); achievement of EMT ≥7 mm; implantation rate; clinical pregnancy rate; safety and tolerability endpoints. By integrating clinical practice with a structured interventional research framework, the PMA_PREPAIRE study aims to generate high-quality prospective evidence and contribute to the future development of standardized clinical recommendations regarding the use of PRP in reproductive medicine and refractory thin endometrium.
- Conditions
- Recurrent Implantation Failure, Endometrial Receptivity Disorders, Embryo Implantation, Platelet-Rich Plasma, Platelet-rich Plasma (PRP), Infertility, Female
- Being tested
- Intrauterine Platelet-Rich Plasma (PRP) Infusion, Hormone Replacement Therapy (HRT)
- Keywords
- Endometrial receptivity, Recurrent implantation failure, Assisted reproductive technology, Platelet-rich plasma, Intrauterine infusion, Autologous biological therapy
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine Platelet-Rich Plasma (PRP) InfusionProcedure or surgery
Autologous platelet-rich plasma (PRP) is prepared from peripheral venous blood collected from the participant and processed using a standardized double-centrifugation technique to obtain a platelet-concentrated plasma fraction. The PRP is administered via intrauterine infusion using a sterile flexible catheter in an outpatient setting without anesthesia. Up to three infusions may be performed within a treatment cycle based on endometrial response. The procedure is performed in addition to standard hormone replacement therapy (HRT) for endometrial preparation.
Hormone Replacement Therapy (HRT)Drug
Standard estrogen therapy used for endometrial preparation.
| Study group | Role | What they receive |
|---|---|---|
| Autologous platelet-rich plasma (PRP) Group | Experimental | Autologous platelet-rich plasma (PRP) is prepared from peripheral venous blood collected from the participant and processed using a standardized double-centrifugation technique to obtain a platelet-concentrated plasma fraction. Participants in this arm receive a standard hormone replacement therapy (HRT) protocol combined with intrauterine infusions of autologous platelet-rich plasma (PRP). HRT begins on cycle days 1-2, with serial ultrasound monitoring of endometrial thickness. If endometrial thickness (EMT) is ≤ 7 mm, one to three intrauterine PRP infusions are administered according to protocol. Participants proceed to embryo transfer once EMT ≥ 7 mm. Follow-up includes β-hCG testing and confirmatory ultrasound to assess clinical pregnancy outcomes. This arm represents the sole prospective intervention group in the study, with outcomes compared to a retrospective control group from historical data. Receives: Procedure: Intrauterine Platelet-Rich Plasma (PRP) Infusion; Drug: Hormone Replacement Therapy (HRT) |
| External Control | Active comparator | This arm consists of a prospective control cohort of patients treated at the same center during the study period. Patients meet eligibility criteria comparable to the intervention group, including refractory thin endometrium (<7 mm after at least 10 days of HRT) and history of failed embryo transfer.
Participants receive standard hormone replacement therapy (HRT) alone without intrauterine PRP infusion. Clinical, ultrasonographic, and reproductive outcome data are collected prospectively using the same monitoring schedule applied to the intervention group, including endometrial thickness, implantation rate, clinical pregnancy, and adverse events.
This control group allows prospective comparison between HRT + PRP and standard HRT while reducing the methodological limitations associated with retrospective historical controls. Receives: Drug: Hormone Replacement Therapy (HRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial Thickness ≥ 7 mm After PRP Treatment
Proportion of participants achieving endometrial thickness (EMT) ≥ 7 mm after intrauterine infusion of autologous platelet-rich plasma during hormone replacement therapy.
Measured: Up to 14 days after initiation of hormone replacement therapy within the treatment cycle.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Recurrent Implantation FailureStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a Parallel Assignment intervention model. Participants are prospectively allocated to one of two study groups according to clinical indication and informed consent: \- an intervention group receiving intrauterine infusion of autologous platelet-rich plasma (PRP) in addition to standard hormone replacement therapy (HRT); a control group receiving standard HRT alone without PRP. The study is conducted as a prospective, controlled, non-randomized interventional clinical trial. Both groups follow predefined clinical protocols and undergo the same prospective clinical, ultrasonographic, and reproductive outcome assessments. This design was selected to allow a controlled prospective evaluation of the efficacy and safety of intrauterine PRP infusion while reducing the methodological limitations and potential biases associated with retrospective historical controls.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale di Asti
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- ELISABETTA DOLFIN, PI, Study director, ASL ATSANDRO MACCHI, CO-PI, Study chair, ASL AT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455773
- Sponsor's protocol ID
- PMA_PREPAIRE STUDY ASL AT
- Acronym
- PMA_PREPAIRE
- Status last verified
- May 2026
- First submitted
- 3 Mar 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) collected in this study will not be shared outside the sponsoring institution. Data contain sensitive health information and are stored within the secure institutional database of ASL AT in compliance with GDPR regulations. Aggregate study results will be published, but access to de-identified individual-level data is not planned.
Publications
Yahyaei A, Madani T, Vesali S, Mashayekhi M. Intrauterine infusion of autologous platelet rich plasma can be an efficient treatment for patients with unexplained recurrent implantation failure. Sci Rep. 2024 Oct 29;14(1):26009. doi: 10.1038/s41598-024-77578-1.
PubMed 39472511Mouanness M, Ali-Bynom S, Jackman J, Seckin S, Merhi Z. Use of Intra-uterine Injection of Platelet-rich Plasma (PRP) for Endometrial Receptivity and Thickness: a Literature Review of the Mechanisms of Action. Reprod Sci. 2021 Jun;28(6):1659-1670. doi: 10.1007/s43032-021-00579-2. Epub 2021 Apr 22.
PubMed 33886116Nazari L, Salehpour S, Hosseini S, Sheibani S, Hosseinirad H. The Effects of Autologous Platelet-Rich Plasma on Pregnancy Outcomes in Repeated Implantation Failure Patients Undergoing Frozen Embryo Transfer: A Randomized Controlled Trial. Reprod Sci. 2022 Mar;29(3):993-1000. doi: 10.1007/s43032-021-00669-1. Epub 2021 Oct 14.
PubMed 34651260Chang Y, Li J, Chen Y, Wei L, Yang X, Shi Y, Liang X. Autologous platelet-rich plasma promotes endometrial growth and improves pregnancy outcome during in vitro fertilization. Int J Clin Exp Med. 2015 Jan 15;8(1):1286-90. eCollection 2015.
PubMed 25785127Kasius A, Smit JG, Torrance HL, Eijkemans MJ, Mol BW, Opmeer BC, Broekmans FJ. Endometrial thickness and pregnancy rates after IVF: a systematic review and meta-analysis. Hum Reprod Update. 2014 Jul-Aug;20(4):530-41. doi: 10.1093/humupd/dmu011. Epub 2014 Mar 23.
PubMed 24664156
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PMA_PREPAIRE STUDY: 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.
- ClinicalTrials.gov ID
- NCT07455773
- Acronym / sponsor ID
- PMA_PREPAIRE / PMA_PREPAIRE STUDY ASL AT
- Conditions
- Recurrent Implantation Failure, Endometrial Receptivity Disorders, Embryo Implantation, Platelet-Rich Plasma, Platelet-rich Plasma (PRP), Infertility, Female
- Keywords
- Endometrial receptivity, Recurrent implantation failure, Assisted reproductive technology, Platelet-rich plasma, Intrauterine infusion, Autologous biological therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Azienda Sanitaria Locale di AstiOther government
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Mar 2026 (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.
Endometrial receptivity is a key determinant of success in assisted reproductive technology (ART). A significant proportion of patients experience repeated implantation failure despite euploid embryos and adequate laboratory conditions. Thin endometrium, often defined as ultrasound-measured thickness <7 mm at embryo transfer, is frequently refractory to estrogen therapy and associated with low implantation and clinical pregnancy rates.
Platelet-Rich Plasma (PRP), obtained from autologous blood by double centrifugation, is rich in growth factors capable of stimulating cell proliferation, angiogenesis, and tissue regeneration, suggesting potential benefits for endometrial function. Preliminary studies indicate improved endometrial thickness and reproductive outcomes following intrauterine PRP infusion, but standardized protocols and systematic data are lacking.
The PMA_PREPAIRE study is a prospective, single-center, controlled, non-randomized interventional clinical trial conducted at the Reproductive Medicine Center of Cardinal Massaia Hospital, Asti. The study aims to evaluate the efficacy and safety of intrauterine infusion of autologous platelet-rich plasma (PRP), in association with hormone replacement therapy (HRT), in improving endometrial receptivity and reproductive outcomes in women with thin or refractory endometrium. The study includes a prospective control group treated with standard HRT alone.
Eligible women will be treated with standard clinical care, with PRP infusion offered to those with insufficient response to HRT. Inclusion criteria include age 18-45, BMI 18-30 kg/m², history of ≥1 failed embryo transfer, EMT <5 mm after ≥10 days of HRT, and normal routine lab tests. Exclusion criteria include endometrial disease, recent gynecological infection, and systemic conditions such as thrombocytopenia or coagulopathies.
Procedures include standard HRT from cycle days 1-2, serial ultrasound monitoring of endometrial thickness from days 6-8, intrauterine PRP infusion if EMT ≤7 mm (up to three infusions per cycle), embryo transfer once EMT ≥7 mm, and follow-up through pregnancy testing and confirmatory ultrasound.
Collected data will be analyzed using descriptive statistics, paired and unpaired comparative analyses, and multivariate logistic regression models to evaluate predictors of treatment response and reproductive outcomes (significance level p < 0.05).
A sample size of 34 patients per group was estimated to detect a 1.5 mm difference in endometrial thickness (EMT) with 90% statistical power. Considering an anticipated dropout rate of 15%, a total of 40 patients per group will be enrolled.
The study includes:
an intervention group consisting of 40 patients treated with HRT plus intrauterine PRP infusion; a prospective control group consisting of 40 patients with refractory thin endometrium treated with standard HRT alone, without PRP.
Detailed description
Endometrial receptivity plays a central role in the implantation process and the success of assisted reproductive technologies (ART). A receptive endometrium undergoes synchronized cellular proliferation, vascularization, stromal decidualization, and expression of specific cytokines and adhesion molecules at the time of embryo transfer. Thin endometrium, commonly defined as a transvaginal ultrasound-measured thickness of less than 7 mm, is frequently encountered in patients undergoing ART and is associated with lower implantation and clinical pregnancy rates.
Refractoriness of the endometrium to standard hormone replacement therapy (HRT) represents a persistent clinical challenge. Despite optimization of estrogen administration routes and doses, a significant subset of patients fails to achieve adequate thickness and functional receptivity. These patients often experience repeated implantation failure (RIF), defined by multiple unsuccessful implantation attempts despite transfer of high-quality embryos.
Platelet-Rich Plasma (PRP) is an autologous biological product obtained from peripheral blood through differential centrifugation. PRP contains a high concentration of platelets, which store a complex milieu of growth factors and cytokines, including platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-β), vascular endothelial growth factor (VEGF), and epidermal growth factor (EGF). These bioactive molecules have mitogenic, angiogenic, and chemotactic properties that facilitate tissue repair and regeneration. The theoretical rationale for PRP application in reproductive medicine is based on its potential to augment stromal proliferation, enhance microvascular growth, and improve the structural and functional characteristics of the endometrium.
Preliminary evidence from observational and interventional clinical studies suggests that intrauterine infusion of autologous PRP may be associated with increased endometrial thickness, improved uterine hemodynamics, and enhanced reproductive outcomes, including implantation and clinical pregnancy rates. In retrospective cohort analyses, patients treated with PRP showed significant improvements in endometrial parameters and pregnancy outcomes compared to conventional therapy. Although variations exist in study designs, inclusion criteria, and infusion protocols, a recurring finding is the promising therapeutic effect of PRP on endometrial receptivity.
Despite these encouraging data, the current literature also highlights the lack of standardized protocols and high-quality, large-scale randomized controlled trials. Systematic reviews and meta-analyses have underscored the need for well-designed clinical trials to establish the reproducibility and clinical validity of PRP therapy in this context. Some guidelines and expert groups note that while the biological rationale is strong, PRP use cannot yet be universally recommended without further evidence from rigorously controlled studies.
The PMA_PREPAIRE study was designed to address the current lack of robust clinical evidence regarding the use of intrauterine autologous platelet-rich plasma (PRP) in patients with refractory thin endometrium undergoing assisted reproductive technology (ART) treatments.
The study prospectively evaluates the efficacy and safety of intrauterine PRP infusion in a controlled clinical setting, comparing reproductive and endometrial outcomes between patients treated with HRT plus PRP and a prospective control group receiving standard HRT alone.
The trial design aims to combine real-world clinical applicability with methodological rigor through:
- predefined inclusion and exclusion criteria; standardized PRP preparation and infusion procedures; prospective and structured data collection; controlled comparison between study groups.
Primary and secondary outcomes include:
- changes in endometrial thickness (EMT); achievement of EMT ≥7 mm; implantation rate; clinical pregnancy rate; safety and tolerability endpoints. By integrating clinical practice with a structured interventional research framework, the PMA_PREPAIRE study aims to generate high-quality prospective evidence and contribute to the future development of standardized clinical recommendations regarding the use of PRP in reproductive medicine and refractory thin endometrium.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a Parallel Assignment intervention model. Participants are prospectively allocated to one of two study groups according to clinical indication and informed consent: - an intervention group receiving intrauterine infusion of autologous platelet-rich plasma (PRP) in addition to standard hormone replacement therapy (HRT); a control group receiving standard HRT alone without PRP. The study is conducted as a prospective, controlled, non-randomized interventional clinical trial. Both groups follow predefined clinical protocols and undergo the same prospective clinical, ultrasonographic, and reproductive outcome assessments. This design was selected to allow a controlled prospective evaluation of the efficacy and safety of intrauterine PRP infusion while reducing the methodological limitations and potential biases associated with retrospective historical controls.
| Arm | Type | Receives |
|---|---|---|
| Autologous platelet-rich plasma (PRP) Group | Experimental | Procedure: Intrauterine Platelet-Rich Plasma (PRP) Infusion, Drug: Hormone Replacement Therapy (HRT)Autologous platelet-rich plasma (PRP) is prepared from peripheral venous blood collected from the participant and processed using a standardized double-centrifugation technique to obtain a platelet-concentrated plasma fraction. Participants in this arm receive a standard hormone replacement therapy (HRT) protocol combined with intrauterine infusions of autologous platelet-rich plasma (PRP). HRT begins on cycle days 1-2, with serial ultrasound monitoring of endometrial thickness. If endometrial thickness (EMT) is ≤ 7 mm, one to three intrauterine PRP infusions are administered according to protocol. Participants proceed to embryo transfer once EMT ≥ 7 mm. Follow-up includes β-hCG testing and confirmatory ultrasound to assess clinical pregnancy outcomes. This arm represents the sole prospective intervention group in the study, with outcomes compared to a retrospective control group from historical data. |
| External Control | Active comparator | Drug: Hormone Replacement Therapy (HRT)This arm consists of a prospective control cohort of patients treated at the same center during the study period. Patients meet eligibility criteria comparable to the intervention group, including refractory thin endometrium (<7 mm after at least 10 days of HRT) and history of failed embryo transfer. Participants receive standard hormone replacement therapy (HRT) alone without intrauterine PRP infusion. Clinical, ultrasonographic, and reproductive outcome data are collected prospectively using the same monitoring schedule applied to the intervention group, including endometrial thickness, implantation rate, clinical pregnancy, and adverse events. This control group allows prospective comparison between HRT + PRP and standard HRT while reducing the methodological limitations associated with retrospective historical controls. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female patients aged 18 to 45 years
- Body mass index (BMI) between 18 and 30 kg/m
- Undergoing assisted reproductive technology (ART) cycle with hormone replacement therapy
- Endometrial thickness < 7 mm after at least 10 days of hormone replacement therapy
- History of at least one failed embryo transfer
Key exclusion criteria (7 listed)
- Endometrial hyperplasia or uterine malignancy
- Active pelvic inflammatory disease or untreated sexually transmitted infection
- Coagulation disorders or platelet abnormalities
- Thrombocytopenia (<100,000/mm³)
- Chronic anticoagulant therapy
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 |
|---|---|---|
| Intrauterine Platelet-Rich Plasma (PRP) InfusionAutologous platelet-rich plasma (PRP) is prepared from peripheral venous blood collected from the participant and processed using a standardized double-centrifugation technique to obtain a platelet-concentrated plasma fraction. The PRP is administered via intrauterine infusion using a sterile flexible catheter in an outpatient setting without anesthesia. Up to three infusions may be performed within a treatment cycle based on endometrial response. The procedure is performed in addition to standard hormone replacement therapy (HRT) for endometrial preparation. | Procedure or surgery | Autologous platelet-rich plasma (PRP) Group |
| Hormone Replacement Therapy (HRT)Standard estrogen therapy used for endometrial preparation. | Drug | Autologous platelet-rich plasma (PRP) Group, External Control |
Primary outcome
Endometrial Thickness ≥ 7 mm After PRP Treatment
Time frame: Up to 14 days after initiation of hormone replacement therapy within the treatment cycle.
Proportion of participants achieving endometrial thickness (EMT) ≥ 7 mm after intrauterine infusion of autologous platelet-rich plasma during hormone replacement therapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 39472511Yahyaei A, Madani T, Vesali S, Mashayekhi M. Intrauterine infusion of autologous platelet rich plasma can be an efficient treatment for patients with unexplained recurrent implantation failure. Sci Rep. 2024 Oct 29;14(1):26009. doi: 10.1038/s41598-024-77578-1.
- Background: PubMed 33886116Mouanness M, Ali-Bynom S, Jackman J, Seckin S, Merhi Z. Use of Intra-uterine Injection of Platelet-rich Plasma (PRP) for Endometrial Receptivity and Thickness: a Literature Review of the Mechanisms of Action. Reprod Sci. 2021 Jun;28(6):1659-1670. doi: 10.1007/s43032-021-00579-2. Epub 2021 Apr 22.
- Background: PubMed 34651260Nazari L, Salehpour S, Hosseini S, Sheibani S, Hosseinirad H. The Effects of Autologous Platelet-Rich Plasma on Pregnancy Outcomes in Repeated Implantation Failure Patients Undergoing Frozen Embryo Transfer: A Randomized Controlled Trial. Reprod Sci. 2022 Mar;29(3):993-1000. doi: 10.1007/s43032-021-00669-1. Epub 2021 Oct 14.
- Background: PubMed 25785127Chang Y, Li J, Chen Y, Wei L, Yang X, Shi Y, Liang X. Autologous platelet-rich plasma promotes endometrial growth and improves pregnancy outcome during in vitro fertilization. Int J Clin Exp Med. 2015 Jan 15;8(1):1286-90. eCollection 2015.
- Background: PubMed 24664156Kasius A, Smit JG, Torrance HL, Eijkemans MJ, Mol BW, Opmeer BC, Broekmans FJ. Endometrial thickness and pregnancy rates after IVF: a systematic review and meta-analysis. Hum Reprod Update. 2014 Jul-Aug;20(4):530-41. doi: 10.1093/humupd/dmu011. Epub 2014 Mar 23.
- Individual participant dataSharing planned: No. The individual participant data (IPD) collected in this study will not be shared outside the sponsoring institution. Data contain sensitive health information and are stored within the secure institutional database of ASL AT in compliance with GDPR regulations. Aggregate study results will be published, but access to de-identified individual-level data is not planned.
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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.
MANUELA CANICATTI', Clinical Trials Coordinator contact
ELISABETTA DOLFIN, PI study director
ASL AT
SANDRO MACCHI, CO-PI study chair
ASL AT
Questions about this trial
What is this clinical trial studying?
A study testing Intrauterine Platelet-Rich Plasma (PRP) Infusion and Hormone Replacement Therapy (HRT) in people with Recurrent Implantation Failure and Endometrial Receptivity Disorders, run by Azienda Sanitaria Locale di Asti.
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 7 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: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ELISABETTA DOLFIN, PRINCIPAL INVESTIGATOR (+39 3381787959 ext. +39 0141 9525, edolfin@asl.at.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometrial Thickness ≥ 7 mm After PRP Treatment (time frame: Up to 14 days after initiation of hormone replacement therapy within the treatment cycle.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07455773, which also lists 5 linked publications.
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 14 May 2026.