InfertilityNCT07020546
Ovarian PRP Injections for Improved Embryo Quality Using Embryo Quality Score
A study testing Ovarian Platelet-rich plasma (PRP) injections in people with Infertility and Poor Ovarian Reserve, run by Generation Next Fertility at 1 site in United States.
Trial summary
Patients will have ovarian PRP treatments and embryo development will be observed using time-lapse imaging and AI software. Read more about this study
- Who is it for?
- Ages 18 to 47 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Poor Ovarian Reserve, Embryo Growth Disorder
- What is being tested?
- Ovarian Platelet-rich plasma (PRP) injections
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2025to 30 Aug 2026
- 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 47 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- No none contraindications to IVF or PRP treatment
- Adequate ovarian reserves and AMH level
- Willingness to undergo two IVF cycles and oPRP treatment
Who cannot join
- Anovulation due to menopause or perimenopause
- Any health conditions that are contraindicated for IVF or oPRP treatment
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
Generation Next Fertility
New York, New York, 10022
Alicia L Broussard, PhD, 212-641-0906, a.broussard@generationnextfertility.com
About this study
Official title: Ovarian Platelet-Rich Plasma (oPRP) Injections Improvement In IVF Patients Based On Time-Lapse Incubator Culture for Automated Tracking and AI for Embryo Quality Assessment : A Non-Randomized Propsective Self-Controlled Interventional Study
Patients will have ovarian PRP treatments and embryo development will be observed using time-lapse imaging and AI software.
Read the detailed description
. oPRP Treatment \& Second IVF Cycle (Study Cycle)
- Following the first IVF cycle, patients will undergo their first oPRP injection:
- Timing: 1-2 weeks after the onset of the next menstrual cycle.
- Procedure: Under IV sedation, a patient's autologous PRP will be prepared and injected directly into both ovaries under transvaginal ultrasound guidance.
- Second IVF Cycle (oPRP Study Cycle)
- The same ovarian stimulation protocol will be used for consistency.
- A second oPRP injection will be performed on stimulation days 2-5 to enhance folliculogenesis.
- Ovulation will be triggered at the same follicular size thresholds, and oocyte retrieval will follow identical protocols.
- Fertilization methodology will be identical to the first cycle unless no fertilization is identified in the first cycle.
- Embryo Development Analysis: Up to 15 embryos will be cultured in the AI incubator, where time-lapse imaging will track their morphokinetics, and AI-based analysis will assess embryo viability and implantation potential.
- Being tested
- Ovarian Platelet-rich plasma (PRP) injections
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovarian Platelet-rich plasma (PRP) injectionsProcedure or surgery
This is a procedure that our patients receive at our clinic. We want to use the AI software to evaluate embryo development before and after treatment to see if there is a difference in embryo quality after PRP treatment within the same patient.
| Study group | Role | What they receive |
|---|---|---|
| Embryo Development Before and After Ovarian PRP Using Time-Lapse AI Embryo Quality Score | Experimental | Patients will undergo two IVF cycles. The first cycle will be before ovarian PRP treatment and the second will be after. The embryo development measured by data gathered in time-lapse imaging and AI software will be used to determine differences between the groups within the same patient Receives: Procedure: Ovarian Platelet-rich plasma (PRP) injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blastocyst formation and embryo quality
The number of high quality embryos that are created per cycle
Measured: 1 year
Secondary outcomes (1)
Live birth rate per transfer
The number of live births following embryo transfer
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start8 Jul 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- A NON-RANDOMIZED PROSPECTIVE SELF-CONTROLLED INTERVENTIONAL STUDY
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Generation Next Fertility
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jesse Hade, MD, Principal investigator, Generation Next Fertility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020546
- Sponsor's protocol ID
- IORG0010499-012025
- Status last verified
- Jun 2025
- First submitted
- 13 May 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Platelet-Rich Plasma (oPRP) Injections Improvement In IVF Patients Based On Time-Lapse Incubator Culture for Automated Tracking and AI for Embryo Quality Assessment : A Non-Randomized Propsective Self-Controlled Interventional Study
- ClinicalTrials.gov ID
- NCT07020546
- Acronym / sponsor ID
- IORG0010499-012025
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Generation Next FertilityUniversity, hospital or other
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 13 Jun 2025 (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 will have ovarian PRP treatments and embryo development will be observed using time-lapse imaging and AI software.
Detailed description
. oPRP Treatment \& Second IVF Cycle (Study Cycle)
- Following the first IVF cycle, patients will undergo their first oPRP injection:
- Timing: 1-2 weeks after the onset of the next menstrual cycle.
- Procedure: Under IV sedation, a patient's autologous PRP will be prepared and injected directly into both ovaries under transvaginal ultrasound guidance.
- Second IVF Cycle (oPRP Study Cycle)
- The same ovarian stimulation protocol will be used for consistency.
- A second oPRP injection will be performed on stimulation days 2-5 to enhance folliculogenesis.
- Ovulation will be triggered at the same follicular size thresholds, and oocyte retrieval will follow identical protocols.
- Fertilization methodology will be identical to the first cycle unless no fertilization is identified in the first cycle.
- Embryo Development Analysis: Up to 15 embryos will be cultured in the AI incubator, where time-lapse imaging will track their morphokinetics, and AI-based analysis will assess embryo viability and implantation potential.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A NON-RANDOMIZED PROSPECTIVE SELF-CONTROLLED INTERVENTIONAL STUDY
| Arm | Type | Receives |
|---|---|---|
| Embryo Development Before and After Ovarian PRP Using Time-Lapse AI Embryo Quality Score | Experimental | Procedure: Ovarian Platelet-rich plasma (PRP) injectionsPatients will undergo two IVF cycles. The first cycle will be before ovarian PRP treatment and the second will be after. The embryo development measured by data gathered in time-lapse imaging and AI software will be used to determine differences between the groups within the same patient |
Who may qualify
- Ages
- 18 to 47 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- No none contraindications to IVF or PRP treatment
- Adequate ovarian reserves and AMH level
- Willingness to undergo two IVF cycles and oPRP treatment
Key exclusion criteria (2 listed)
- Anovulation due to menopause or perimenopause
- Any health conditions that are contraindicated for IVF or oPRP treatment
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 |
|---|---|---|
| Ovarian Platelet-rich plasma (PRP) injectionsThis is a procedure that our patients receive at our clinic. We want to use the AI software to evaluate embryo development before and after treatment to see if there is a difference in embryo quality after PRP treatment within the same patient. | Procedure or surgery | Embryo Development Before and After Ovarian PRP Using Time-Lapse AI Embryo Quality Score |
Primary outcome
Blastocyst formation and embryo quality
Time frame: 1 year
The number of high quality embryos that are created per cycle
1 secondary outcome
Live birth rate per transfer
Time frame: 2 years
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 9 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Infertility
RecruitingPhase 3
A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)
Infertility
Active, not recruitingObservational study
Fresh Versus Vitrified-Warmed Donor Oocytes: Embryological and Clinical Outcomes
Infertility, Donor Oocyte Assisted Reproduction
RecruitingObservational study
Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
Infertility
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
Not yet recruiting
Implementing IVM for Fertility Treatment in Clinical Practice
Infertility
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.
Jesse Hade, MD principal investigator
Generation Next Fertility
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ovarian Platelet-rich plasma (PRP) injections in people with Infertility and Poor Ovarian Reserve, run by Generation Next Fertility 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 3 inclusion and 2 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 9 Jul 2025. 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. 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 Alicia L Broussard, PhD (3174456958, a.broussard@generationnextfertility.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blastocyst formation and embryo quality (time frame: 1 year). 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 9 Jul 2025.