InfertilityEarly Phase 1NCT03379649
Platelet Rich Plasma for Patients With Recurrent Implantation Failure
A Early Phase 1 study testing Platelet rich plasma in people with Infertility, run by Stanford University at 1 site in United States.
Trial summary
Patients with recurrent implantation failure are among the most difficult patients to treat, with no proven standard treatment. Platelet rich plasma stimulates cellular processes involved in endometrial regeneration, and in a small case series has shown efficacy for this patient population. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Platelet rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2019to 20 Dec 2023
- Phase
- Early 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All women who have undergone 3 or more embryo (blastocyst stage) transfers without establishing a clinical pregnancy or 2 or more euploid embryo transfers without establishing a clinical pregnancy, aged 18 - 45, with a normal uterine cavity established within 12 months by hysteroscopy or saline infusion sonogram, planning in vitro fertilization with an embryo transfer at Stanford Fertility and Reproductive Health. The planned transfer must consist of any of the following: a PGS proven euploid embryo, a good quality blastocyst from a patient younger than 37, or a donor oocyte blastocyst.
Who cannot join
- Abnormal uterine cavity, planning in vitro fertilization with use of a gestational carrier. patients enrolled in other experimental interventions for RIF will be excluded. Patients with only poor quality or cleavage stage embryos.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Fertility and Reproductive Health
Sunnyvale, California, 94087
About this study
Official title: Platelet Rich Plasma for Patients With Recurrent Implantation Failure: A Prospective Randomized Pilot Study
Patients with recurrent implantation failure are among the most difficult patients to treat, with no proven standard treatment. Platelet rich plasma stimulates cellular processes involved in endometrial regeneration, and in a small case series has shown efficacy for this patient population. We hope to conduct a randomized controlled pilot study to determine whether PRP is indeed an effective treatment for recurrent implantation failure.
Read the detailed description
Patients considered to have recurrent implantation failure will undergo randomization to receive intrauterine infusions of platelet rich plasma or a placebo of embryo culture media prior to their embryo transfer. All patients will undergo a blood draw to obtain 60ml of blood from which 0.5ml of platelet rich plasma will be obtained. Those randomized to receive the platelet rich plasma will have platelet rich plasma placed into the uterine cavity at least 48 hours prior to the embryo transfer, while those randomized to receive placebo will have embryo culture media placed into the uterine cavity at the same point in time. Those randomized to the placebo group will have the opportunity to be placed into the treatment group if no pregnancy was attained. Transfer outcomes including implantation rate, pregnancy rate, and live birth rate, will be recorded.
- Conditions
- Infertility
- Being tested
- Platelet rich plasma, Placebo
- Keywords
- Recurrent implantation failure
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich plasmaCombination product
Patients will have 60ml of blood drawn. Platelet rich plasma will be obtained by placing the blood in the Arteriocyte Magellan device. 0.5ml of Platelet rich plasma will be placed into the uterus at least 48 hours prior to embryo transfer.
PlaceboCombination product
Patients will have 60ml of blood drawn. 0.5ml of embryo culture media (the placebo) will be placed into the uterus at least 48 hours prior to embryo transfer.
| Study group | Role | What they receive |
|---|---|---|
| PRP | Experimental | Patient with recurrent implantation failure who receives intrauterine infusion of platelet rich plasma Receives: Combination Product: Platelet rich plasma |
| Placebo | Placebo comparator | Patient with recurrent implantation failure who receives intrauterine infusion of embryo culture media Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Live birth/embryo transfer
Measured: 10 months following transfer
Secondary outcomes (1)
Pregnancy
Positive pregnancy test/embryo transferred
Measured: 9 days following transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start16 Jan 2019
- Primary completion20 Dec 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lusine Aghajanova, Stanford University
- Investigators
- Lusine Aghajanova, M.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379649
- Sponsor's protocol ID
- 43265
- Status last verified
- Dec 2023
- First submitted
- 15 Dec 2017
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Nazari L, Salehpour S, Hoseini S, Zadehmodarres S, Ajori L. Effects of autologous platelet-rich plasma on implantation and pregnancy in repeated implantation failure: A pilot study. Int J Reprod Biomed. 2016 Oct;14(10):625-628.
PubMed 27921085Aghajanova L, Strug M, Zhang J, Lathi RB. Intrauterine platelet-rich plasma infusion for recurrent implantation failure: a pilot randomized controlled single-blinded clinical trial in the USA. J Assist Reprod Genet. 2026 Feb;43(2):639-650. doi: 10.1007/s10815-025-03752-7. Epub 2025 Nov 17.
PubMed 41247443
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Rich Plasma for Patients With Recurrent Implantation Failure: A Prospective Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT03379649
- Acronym / sponsor ID
- 43265
- Conditions
- Infertility
- Keywords
- Recurrent implantation failure
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 20 Dec 2017 (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.
Patients with recurrent implantation failure are among the most difficult patients to treat, with no proven standard treatment. Platelet rich plasma stimulates cellular processes involved in endometrial regeneration, and in a small case series has shown efficacy for this patient population. We hope to conduct a randomized controlled pilot study to determine whether PRP is indeed an effective treatment for recurrent implantation failure.
Detailed description
Patients considered to have recurrent implantation failure will undergo randomization to receive intrauterine infusions of platelet rich plasma or a placebo of embryo culture media prior to their embryo transfer. All patients will undergo a blood draw to obtain 60ml of blood from which 0.5ml of platelet rich plasma will be obtained. Those randomized to receive the platelet rich plasma will have platelet rich plasma placed into the uterine cavity at least 48 hours prior to the embryo transfer, while those randomized to receive placebo will have embryo culture media placed into the uterine cavity at the same point in time. Those randomized to the placebo group will have the opportunity to be placed into the treatment group if no pregnancy was attained. Transfer outcomes including implantation rate, pregnancy rate, and live birth rate, will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP | Experimental | Combination Product: Platelet rich plasmaPatient with recurrent implantation failure who receives intrauterine infusion of platelet rich plasma |
| Placebo | Placebo comparator | Combination Product: PlaceboPatient with recurrent implantation failure who receives intrauterine infusion of embryo culture media |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All women who have undergone 3 or more embryo (blastocyst stage) transfers without establishing a clinical pregnancy or 2 or more euploid embryo transfers without establishing a clinical pregnancy, aged 18 - 45, with a normal uterine cavity established within 12 months by hysteroscopy or saline infusion sonogram, planning in vitro fertilization with an embryo transfer at Stanford Fertility and Reproductive Health. The planned transfer must consist of any of the following: a PGS proven euploid embryo, a good quality blastocyst from a patient younger than 37, or a donor oocyte blastocyst.
Key exclusion criteria (1 listed)
- Abnormal uterine cavity, planning in vitro fertilization with use of a gestational carrier. patients enrolled in other experimental interventions for RIF will be excluded. Patients with only poor quality or cleavage stage embryos.
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 |
|---|---|---|
| Platelet rich plasmaPatients will have 60ml of blood drawn. Platelet rich plasma will be obtained by placing the blood in the Arteriocyte Magellan device. 0.5ml of Platelet rich plasma will be placed into the uterus at least 48 hours prior to embryo transfer. | Combination product | PRP |
| PlaceboPatients will have 60ml of blood drawn. 0.5ml of embryo culture media (the placebo) will be placed into the uterus at least 48 hours prior to embryo transfer. | Combination product | Placebo |
Primary outcome
Live birth rate
Time frame: 10 months following transfer
Live birth/embryo transfer
1 secondary outcome
Pregnancy
Time frame: 9 days following transfer
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 22 Dec 2023.
- Background: PubMed 27921085Nazari L, Salehpour S, Hoseini S, Zadehmodarres S, Ajori L. Effects of autologous platelet-rich plasma on implantation and pregnancy in repeated implantation failure: A pilot study. Int J Reprod Biomed. 2016 Oct;14(10):625-628.
- Derived from this study: PubMed 41247443Aghajanova L, Strug M, Zhang J, Lathi RB. Intrauterine platelet-rich plasma infusion for recurrent implantation failure: a pilot randomized controlled single-blinded clinical trial in the USA. J Assist Reprod Genet. 2026 Feb;43(2):639-650. doi: 10.1007/s10815-025-03752-7. Epub 2025 Nov 17.
- Individual participant dataSharing planned: No
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
Lusine Aghajanova, M.D. principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Platelet rich plasma in people with Infertility, run by Stanford University at 1 site in United States.
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 1 inclusion and 1 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 22 Dec 2023. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Live birth rate (time frame: 10 months following transfer). 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 NCT03379649, which also lists 2 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 22 Dec 2023.