Ovarian FailureNCT04163640
Ovarian Rejuvenation for Premature Ovarian Insufficiency and Poor Ovarian Response
A study testing intra-ovarian platelet rich plasma injection in people with Ovarian Failure and Infertility, Female, run by Reproductive Medicine Associates of New Jersey at 2 sites in 2 countries.
Trial summary
The objective of this study is to perform a prospective randomized controlled trial seeking to characterize the effects of intra-ovarian injection of platelet rich plasma (PRP) on biomarkers of ovarian reserve as well as IVF outcomes in women with primary ovarian insufficiency (POI) and poor ovarian response (POR) who… Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Ovarian Failure, Infertility, Female
- What is being tested?
- intra-ovarian platelet rich plasma injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 24 Feb 2020to 21 Jul 2023
- 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 18 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- POI according to ESHRE criteria (patient must fit both criteria):
- presence of menstrual disturbance defined as oligo/amenorrhea for at least 4 months
- biochemical confirmation as evidenced by an elevated FSH level >25 IU/L on two occasions > 4 weeks apart
- POR defined by at least two prior cycles with POR (≤3 oocytes retrieved with a conventional stimulation protocol, or a cancelled cycle due to poor response)
- Patients declining ovum donation treatment
Who cannot join
- Age <18yo or >38yrs
- Autoimmune or sex chromosome etiology of POI
- Ongoing malignancy
- Previous ovarian surgery
- Previous gonadotoxic treatment
- Anticoagulant use for which plasma infusion is contraindicated
Show all 20Show fewer
- FMR1 mutations
- If the duration of the amenorrhea is more than 2 years, patients are discouraged to participate, although it is not an exclusion criterion.
- Patients with only 1 ovary
- BMI > 35
- Male partner with <100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
- Surgically obtained sperm
- Presence of hydrosalpinges that communicate with endometrial cavity
- Single gene disorder or chromosomal rearrangement requiring a more detailed embryonic genetic analysis
- Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid
- Use of a gestational carrier
- Any contraindications to undergoing in vitro fertilization or gonadotropin stimulation
- Known ovaries that are not accessible transvaginally.
- Ovarian endometrioma(s) or dermoid cyst(s) identified via transvaginal ultrasound
- FSH > 40iu/l
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, 07920
About this study
Official title: Ovarian Rejuvenation Through Intra-ovarian Injection of Platelet Rich Plasma for Women With Premature Ovarian Insufficiency (POI) and Poor Ovarian Response (POR)
The objective of this study is to perform a prospective randomized controlled trial seeking to characterize the effects of intra-ovarian injection of platelet rich plasma (PRP) on biomarkers of ovarian reserve as well as IVF outcomes in women with primary ovarian insufficiency (POI) and poor ovarian response (POR) who decline the use of an egg donor to establish a pregnancy.
Read the detailed description
Patients will be randomized to either receive the intra-ovarian PRP injection procedure or not. Regardless of randomization patients will be re-assessed at the same time points for ovarian reserve parameters. If antral follicles are detected at follow up, patients will undergo controlled ovarian hyperstimulation and a routine in vitro fertilization cycle as per protocol.
- Conditions
- Ovarian Failure, Infertility, Female
- Being tested
- intra-ovarian platelet rich plasma injection
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-ovarian platelet rich plasma injectionOther
patients will undergo a transvaginal intra-ovarian platelet rich plasma injection
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Patients randomized to this group will receive the intra-ovarian platelet rich plasma injection Receives: Other: intra-ovarian platelet rich plasma injection |
| Control Group | No intervention | Patients randomized to this group will not receive the intra-ovarian platelet rich plasma injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with a mature oocyte retrieved- POI group
success or failure is determined by the retrieval of at least one mature oocyte
Measured: 24 hours post egg retrieval procedure
number of mature oocytes retrieved- POR group
the total number of mature oocytes retrieved
Measured: 24 hours post egg retrieval procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start24 Feb 2020
- Primary completion5 Aug 2022
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emre U Seli, MD, Principal investigator, Reproductive Medicine Associates of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163640
- Sponsor's protocol ID
- RMA-2019-05
- Status last verified
- Sep 2023
- First submitted
- 12 Nov 2019
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Herlihy NS, Cakiroglu Y, Whitehead C, Reig A, Tiras B, Scott RT Jr, Seli E. Effect of intraovarian platelet-rich plasma injection on IVF outcomes in women with poor ovarian response: the PROVA randomized controlled trial. Hum Reprod. 2024 May 9:deae093. doi: 10.1093/humrep/deae093. Online ahead of print.
PubMed 38725194
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Rejuvenation Through Intra-ovarian Injection of Platelet Rich Plasma for Women With Premature Ovarian Insufficiency (POI) and Poor Ovarian Response (POR)
- ClinicalTrials.gov ID
- NCT04163640
- Acronym / sponsor ID
- RMA-2019-05
- Conditions
- Ovarian Failure, Infertility, Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 15 Nov 2019 (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.
The objective of this study is to perform a prospective randomized controlled trial seeking to characterize the effects of intra-ovarian injection of platelet rich plasma (PRP) on biomarkers of ovarian reserve as well as IVF outcomes in women with primary ovarian insufficiency (POI) and poor ovarian response (POR) who decline the use of an egg donor to establish a pregnancy.
Detailed description
Patients will be randomized to either receive the intra-ovarian PRP injection procedure or not. Regardless of randomization patients will be re-assessed at the same time points for ovarian reserve parameters. If antral follicles are detected at follow up, patients will undergo controlled ovarian hyperstimulation and a routine in vitro fertilization cycle as per protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: intra-ovarian platelet rich plasma injectionPatients randomized to this group will receive the intra-ovarian platelet rich plasma injection |
| Control Group | No intervention | –Patients randomized to this group will not receive the intra-ovarian platelet rich plasma injection |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- POI according to ESHRE criteria (patient must fit both criteria):
- POR defined by at least two prior cycles with POR (≤3 oocytes retrieved with a conventional stimulation protocol, or a cancelled cycle due to poor response)
- Patients declining ovum donation treatment
Key exclusion criteria (20 listed)
- Age <18yo or >38yrs
- Autoimmune or sex chromosome etiology of POI
- Ongoing malignancy
- Previous ovarian surgery
- Previous gonadotoxic 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 |
|---|---|---|
| intra-ovarian platelet rich plasma injectionpatients will undergo a transvaginal intra-ovarian platelet rich plasma injection | Other | Intervention Group |
Primary outcome
number of participants with a mature oocyte retrieved- POI group
Time frame: 24 hours post egg retrieval procedure
success or failure is determined by the retrieval of at least one mature oocyte
number of mature oocytes retrieved- POR group
Time frame: 24 hours post egg retrieval procedure
the total number of mature oocytes retrieved
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 15 Sep 2023.
- Derived from this study: PubMed 38725194Herlihy NS, Cakiroglu Y, Whitehead C, Reig A, Tiras B, Scott RT Jr, Seli E. Effect of intraovarian platelet-rich plasma injection on IVF outcomes in women with poor ovarian response: the PROVA randomized controlled trial. Hum Reprod. 2024 May 9:deae093. doi: 10.1093/humrep/deae093. Online ahead of print.
- 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. This study is not recruiting at the moment.
Emre U Seli, MD principal investigator
Reproductive Medicine Associates of New Jersey
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intra-ovarian platelet rich plasma injection in people with Ovarian Failure and Infertility, Female, run by Reproductive Medicine Associates of New Jersey at 2 sites in 2 countries.
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 5 inclusion and 20 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 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Turkey (Türkiye). 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?
number of participants with a mature oocyte retrieved- POI group (time frame: 24 hours post egg retrieval procedure). The study lists 2 primary outcomes in all. 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 NCT04163640, which also lists 1 linked publication.
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 15 Sep 2023.