Infertility of Uterine OriginPIERNCT05538338
Platelet Rich Plasma for Insufficient Endometrium
A study testing Platelet Rich Plasma Intrauterine infusion and Normal saline Intrauterine infusion in people with Infertility of Uterine Origin, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
Trial summary
To determine the effectiveness of an intrauterine PRP infusion on endometrial thickness and in vitro fertilization (IVF) outcomes in a population of infertile women with a history of unresponsive thin endometrium. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility of Uterine Origin
- What is being tested?
- Platelet Rich Plasma Intrauterine infusion and Normal saline Intrauterine infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2022to 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
- Patients who have previously undergone at least 2 unsuccessful frozen embryo transfer cycles, defined as failure to achieve a sustained clinical pregnancy (visualization of intrauterine gestational sac on ultrasound or a cancelled embryo transfer cycle due to inadequate endometrial thickness
- Patients with a diagnosis of thin endometrial lining (less than or equal to 6 mm maximum thickness) during prior unsuccessful or canceled embryo transfer cycles.
Who cannot join
- Fewer than 2 prior unsuccessful or canceled frozen embryo transfer cycles.
- Most recent unsuccessful embryo transfer prior to January 1, 2017.
- Mullerian anomalies, excluding arcuate uterus
- Concurrent submucosal fibroids, unrepaired uterine defects or present indication for uterine surgery
- Communicating hydrosalpinx without plans for surgical correction prior to study enrollment.
- Failure of patient to agree to enrollment in study with written consent.
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- Concurrent pregnancy
- Anticoagulation use for which plasma infusion is contraindicated
- History of thrombosis
- Thrombophilia either inherited or acquired
- Concomitant use of adjunctive therapies for proliferation. These must be discontinued upon enrollment.
- Embryo planned to be used for transfer generated from surgically obtained sperm due to a diagnosis of non-obstructive azoospermia
- Recurrent/persistent endometrial fluid in prior cycles
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, 07920
Christine V Whitehead, BSN, RN, 19736562841, cwhitehead@ivirma.com
Caroline Zuckerman, BS, 19736562841, clinicalresearchteam@ivirma.com
About this study
Official title: Intrauterine Platelet Rich Plasma (PRP) Infusion for Endometrial Insufficiency: A Prospective, Double-Blind, Placebo-Controlled Randomized Controlled Trial
To determine the effectiveness of an intrauterine PRP infusion on endometrial thickness and in vitro fertilization (IVF) outcomes in a population of infertile women with a history of unresponsive thin endometrium.
Read the detailed description
Patients with a history of thin endometrium will be randomized to either an intrauterine infusion of PRP vs. a placebo infusion of normal saline. This is a double-blind, placebo controlled prospective RCT. Patients will then proceed with a frozen embryo transfer of a single euploid embryo per routine.
- Conditions
- Infertility of Uterine Origin
- Being tested
- Platelet Rich Plasma Intrauterine infusion, Normal saline Intrauterine infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich Plasma Intrauterine infusionOther
an intrauterine infusion of platelet rich plasma (PRP) will be administered to this group of participants
Normal saline Intrauterine infusionOther
an intrauterine infusion of normal saline will be administered to this group of participants
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | an intrauterine infusion of platelet rich plasma (PRP) will be administered to this group Receives: Other: Platelet Rich Plasma Intrauterine infusion |
| Control Group | Placebo comparator | an intrauterine infusion of normal saline will be administered to this group Receives: Other: Normal saline Intrauterine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial Thickness during frozen embryo transfer
peak endometrial thickness prior to initiation of progesterone
Measured: during the proliferative phase of the frozen embryo transfer cycle
Secondary outcomes (1)
Sustained implantation rate
presence of fetal heart beat upon discharge from care
Measured: approximately 9 weeks gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start15 Oct 2022
- Primary completionOct 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility of Uterine OriginStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538338
- Sponsor's protocol ID
- RMA-2022-04
- Acronym
- PIER
- Status last verified
- Jun 2026
- First submitted
- 9 Sep 2022
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrauterine Platelet Rich Plasma (PRP) Infusion for Endometrial Insufficiency: A Prospective, Double-Blind, Placebo-Controlled Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05538338
- Acronym / sponsor ID
- PIER / RMA-2022-04
- Conditions
- Infertility of Uterine Origin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Sep 2022 (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.
To determine the effectiveness of an intrauterine PRP infusion on endometrial thickness and in vitro fertilization (IVF) outcomes in a population of infertile women with a history of unresponsive thin endometrium.
Detailed description
Patients with a history of thin endometrium will be randomized to either an intrauterine infusion of PRP vs. a placebo infusion of normal saline. This is a double-blind, placebo controlled prospective RCT. Patients will then proceed with a frozen embryo transfer of a single euploid embryo per routine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Other: Platelet Rich Plasma Intrauterine infusionan intrauterine infusion of platelet rich plasma (PRP) will be administered to this group |
| Control Group | Placebo comparator | Other: Normal saline Intrauterine infusionan intrauterine infusion of normal saline will be administered to this group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients who have previously undergone at least 2 unsuccessful frozen embryo transfer cycles, defined as failure to achieve a sustained clinical pregnancy (visualization of intrauterine gestational sac on ultrasound or a cancelled embryo transfer cycle due to inadequate endometrial thickness
- Patients with a diagnosis of thin endometrial lining (less than or equal to 6 mm maximum thickness) during prior unsuccessful or canceled embryo transfer cycles.
Key exclusion criteria (13 listed)
- Fewer than 2 prior unsuccessful or canceled frozen embryo transfer cycles.
- Most recent unsuccessful embryo transfer prior to January 1, 2017.
- Mullerian anomalies, excluding arcuate uterus
- Concurrent submucosal fibroids, unrepaired uterine defects or present indication for uterine surgery
- Communicating hydrosalpinx without plans for surgical correction prior to study enrollment.
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 Plasma Intrauterine infusionan intrauterine infusion of platelet rich plasma (PRP) will be administered to this group of participants | Other | Intervention Group |
| Normal saline Intrauterine infusionan intrauterine infusion of normal saline will be administered to this group of participants | Other | Control Group |
Primary outcome
Endometrial Thickness during frozen embryo transfer
Time frame: during the proliferative phase of the frozen embryo transfer cycle
peak endometrial thickness prior to initiation of progesterone
1 secondary outcome
Sustained implantation rate
Time frame: approximately 9 weeks gestational age
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 3 Jun 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Rich Plasma Intrauterine infusion and Normal saline Intrauterine infusion in people with Infertility of Uterine Origin, run by Reproductive Medicine Associates of New Jersey 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 2 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 3 Jun 2026. 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.
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 Christine V Whitehead, BSN, RN (19736562841, clinicalresearchteam@ivirma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometrial Thickness during frozen embryo transfer (time frame: during the proliferative phase of the frozen embryo transfer cycle). 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 3 Jun 2026.