Primary Ovarian InsufficiencyPRP4POINCT03542708
Injections of Autologous PRP in Women With Primary Ovarian Insufficiency
A study testing A-PRP in people with Primary Ovarian Insufficiency and Premature Menopause, run by Center for Human Reproduction at 1 site in United States.
Trial summary
Premature ovarian failure is a loss of normal function before age 40, leading to infertility and hypoestrogenism. This study will involve only adult women with a diagnosis of POI. Participants will receive injections of autologous PRP in one randomly selected ovary. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Ovarian Insufficiency, Premature Menopause
- What is being tested?
- A-PRP
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2018to 1 Apr 2024
- Phase
- Interventional
- 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 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed and dated informed consent
- Women 40 years of age and younger with documented primary ovarian insufficiency.
- Normal Karyotype
- FSH > 30
- AMH not detectable
- No evidence of follicles > 4mm
Show all 9Show fewer
- Must have two ovaries of approximately equal volume.
- No Aspirin or any NSAID (e.g. Motrin) for approximately one week before treatment
- Willingness to undergo further fertility treatment, including IVF if there is evidence of response
Who cannot join
- Premature ovarian failure due to a genetic origin, such as Turner's Syndrome or chromosomal abnormality
- Marked thrombocytopenia
- Blood diseases
- Hypofibrinogenemia
- Hemodynamic instability
- Anticoagulant or antiaggregant treatment
Show all 12Show fewer
- Oncological diseases (specially, skeletal system and blood)
- Sepsis
- Acute and chronic infectious diseases
- Autoimmune diseases, for example, lupus erythematosus, etc.
- Active substance abuse or dependence
- Major Mental health disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Center For Human Reproduction
New York, New York, 10021
About this study
Official title: Prospectively Randomized Study of Intraovarian Injections of Autologous Platelet-rich Plasma (PRP) in Women With Primary Ovarian Insufficiency (POI)
Premature ovarian failure is a loss of normal function before age 40, leading to infertility and hypoestrogenism. This study will involve only adult women with a diagnosis of POI. Participants will receive injections of autologous PRP in one randomly selected ovary.
Read the detailed description
Premature ovarian failure is a loss of normal function before age 40, leading to infertility and hypoestrogenism. While POI is sometimes called premature menopause, it is not the same thing as menopause. Women with POI may still have occasional irregular periods and may even occasionally achieve a pregnancy. Symptoms of POI include: irregular menses or amenorrhea, infertility, hypoestrogenic symptoms and decreased libido. POI may be caused by Chromosomal defects such as mosaic Turner's syndrome, exposure to toxins (chemotherapy or radiation), autoimmunity, genetic factors (FMR1) and other unknown factors.
Autologous Platelet Rich Plasma (A-PRP) is plasma with a concentration of platelets above the blood baseline. A-PRP is developed from autologous blood. Within A-PRP, the concentration of platelets delivers an increased number of growth factors. In this study A-PRP will be prepared using Regen Lab PRP Kit which is approved by US-FDA for preparation of PRP.
PRP is becoming widely used in a variety of medical procedures seeking tissue remodeling and/or healing as an intervention. To date, applications in orthopedics, wound healing, dermatology and plastic surgery have gained general acceptance, primarily as the role of platelets and their activation in tissue repair and recovery has become better understood at a cellular and molecular level. This knowledge base provides a foundation for the present study because of the ready availability of FDA-approved kits for autologous PRP preparations and the recognition that the aging ovary acquires tissue pathologies in the form of wound healing and fibrosis as a result of repeat ovulations over the reproductive lifespan of women. Since PRP is an autologous blood product, and is widely used via injection into various organs and tissues, safety concerns are minimal.
This study will involve only adult women with a diagnosis of POI. Consenting participants will receive injections of autologous Platelet RIch Plasma (A-PRP) in one randomly selected ovary under ultrasound guidance performed after induction of IV sedation. Randomization will determine whether the right or left ovary will be treated. The result of randomization will not be recorded in the participants clinical chart, but will be maintained in the research database with blinding to all clinical participants. The physician performing the A-PRP administration will not perform post procedure follow-up of those patients. In case of a complication, possibly related to treatment, the case will be unblinded.
The study will be powered to detect a 20% response in the treated ovary (every patient's 2nd ovary will serve as control). This will require 68 ovaries and 34 patients. The study, thus, does not involve randomization of patients because each patient's second ovary functions as control ovary, although which ovary will receive treatment in a given patient will be determined by computer randomization.
- Conditions
- Primary Ovarian Insufficiency, Premature Menopause
- Being tested
- A-PRP
- Medical subject headings
- Primary Ovarian Insufficiency, Menopause, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-PRPProcedure or surgery
Also called Autologous Platelet Rich Plasma
The cortex of selected ovary will be injected with autologous platelet rich plasma. Up to ten different sites will be injected under ultrasound guidance. The patient will be under IV sedation. Record of which ovary was injected will be kept in the online research database and not in the clinical chart.
| Study group | Role | What they receive |
|---|---|---|
| A-PRP | Experimental | The cortex of selected ovary will be injected with autologous platelet rich plasma. Receives: Procedure: A-PRP |
| Control | No intervention | The contralateral ovary will not be injected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian Follicles
Emergence of new ovarian follicles with evidence of estradiol production
Measured: Change from baseline to 12 weeks
Secondary outcomes (3)
Increase in serum AMH
Increase in serum AMH above baseline level
Measured: Change from baseline to 12 weeks
Retrieval of oocytes in an IVF cycle
Retrieval of oocytes in an IVF cycle
Measured: 6 months
Clinical Pregnancy
Establishment of a Clinical pregnancy,
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start25 Jul 2018
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Ovarian InsufficiencyStudies 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
- Model description
- One ovary will be randomly selected for treatment with PRP. The other ovary will serve as a control.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Human Reproduction
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Norbert Gleicher, MD, Principal investigator, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542708
- Sponsor's protocol ID
- 03192018-01
- Acronym
- PRP4POI
- Status last verified
- Apr 2024
- First submitted
- 18 May 2018
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospectively Randomized Study of Intraovarian Injections of Autologous Platelet-rich Plasma (PRP) in Women With Primary Ovarian Insufficiency (POI)
- ClinicalTrials.gov ID
- NCT03542708
- Acronym / sponsor ID
- PRP4POI / 03192018-01
- Conditions
- Primary Ovarian Insufficiency, Premature Menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Center for Human ReproductionUniversity, hospital or other
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 31 May 2018 (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.
Premature ovarian failure is a loss of normal function before age 40, leading to infertility and hypoestrogenism. This study will involve only adult women with a diagnosis of POI. Participants will receive injections of autologous PRP in one randomly selected ovary.
Detailed description
Premature ovarian failure is a loss of normal function before age 40, leading to infertility and hypoestrogenism. While POI is sometimes called premature menopause, it is not the same thing as menopause. Women with POI may still have occasional irregular periods and may even occasionally achieve a pregnancy. Symptoms of POI include: irregular menses or amenorrhea, infertility, hypoestrogenic symptoms and decreased libido. POI may be caused by Chromosomal defects such as mosaic Turner's syndrome, exposure to toxins (chemotherapy or radiation), autoimmunity, genetic factors (FMR1) and other unknown factors.
Autologous Platelet Rich Plasma (A-PRP) is plasma with a concentration of platelets above the blood baseline. A-PRP is developed from autologous blood. Within A-PRP, the concentration of platelets delivers an increased number of growth factors. In this study A-PRP will be prepared using Regen Lab PRP Kit which is approved by US-FDA for preparation of PRP.
PRP is becoming widely used in a variety of medical procedures seeking tissue remodeling and/or healing as an intervention. To date, applications in orthopedics, wound healing, dermatology and plastic surgery have gained general acceptance, primarily as the role of platelets and their activation in tissue repair and recovery has become better understood at a cellular and molecular level. This knowledge base provides a foundation for the present study because of the ready availability of FDA-approved kits for autologous PRP preparations and the recognition that the aging ovary acquires tissue pathologies in the form of wound healing and fibrosis as a result of repeat ovulations over the reproductive lifespan of women. Since PRP is an autologous blood product, and is widely used via injection into various organs and tissues, safety concerns are minimal.
This study will involve only adult women with a diagnosis of POI. Consenting participants will receive injections of autologous Platelet RIch Plasma (A-PRP) in one randomly selected ovary under ultrasound guidance performed after induction of IV sedation. Randomization will determine whether the right or left ovary will be treated. The result of randomization will not be recorded in the participants clinical chart, but will be maintained in the research database with blinding to all clinical participants. The physician performing the A-PRP administration will not perform post procedure follow-up of those patients. In case of a complication, possibly related to treatment, the case will be unblinded.
The study will be powered to detect a 20% response in the treated ovary (every patient's 2nd ovary will serve as control). This will require 68 ovaries and 34 patients. The study, thus, does not involve randomization of patients because each patient's second ovary functions as control ovary, although which ovary will receive treatment in a given patient will be determined by computer randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- One ovary will be randomly selected for treatment with PRP. The other ovary will serve as a control.
| Arm | Type | Receives |
|---|---|---|
| A-PRP | Experimental | Procedure: A-PRPThe cortex of selected ovary will be injected with autologous platelet rich plasma. |
| Control | No intervention | –The contralateral ovary will not be injected. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Signed and dated informed consent
- Women 40 years of age and younger with documented primary ovarian insufficiency.
- Normal Karyotype
- FSH > 30
- AMH not detectable
Key exclusion criteria (12 listed)
- Premature ovarian failure due to a genetic origin, such as Turner's Syndrome or chromosomal abnormality
- Marked thrombocytopenia
- Blood diseases
- Hypofibrinogenemia
- Hemodynamic instability
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 |
|---|---|---|
| A-PRPAlso: Autologous Platelet Rich PlasmaThe cortex of selected ovary will be injected with autologous platelet rich plasma. Up to ten different sites will be injected under ultrasound guidance. The patient will be under IV sedation. Record of which ovary was injected will be kept in the online research database and not in the clinical chart. | Procedure or surgery | A-PRP |
Primary outcome
Ovarian Follicles
Time frame: Change from baseline to 12 weeks
Emergence of new ovarian follicles with evidence of estradiol production
3 secondary outcomes
Increase in serum AMH
Time frame: Change from baseline to 12 weeks
Retrieval of oocytes in an IVF cycle
Time frame: 6 months
Clinical Pregnancy
Time frame: 12 months
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 10 Jul 2024.
- Individual participant dataSharing planned: Yes. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research
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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. This study is not recruiting at the moment.
Norbert Gleicher, MD principal investigator
Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A-PRP in people with Primary Ovarian Insufficiency and Premature Menopause, run by Center for Human Reproduction 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 9 inclusion and 12 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 10 Jul 2024. 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?
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?
Ovarian Follicles (time frame: Change from baseline to 12 weeks). 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 10 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.