Low Ovarian ReserveNCT06975683
Open, Non-comparative Pilot Study to Evaluate the Safety and Efficacy of Intraovarian Plasma Rich in Growth Factors (PRGF) in Patients With Low Ovarian Reserve
A study testing Plasma Rich in Growth Factors (PRGF) in people with Low Ovarian Reserve, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
Trial summary
The use of plasma rich in growth factors (PRGF) improves ovarian reserve markers and IVF laboratory parameters in women with low ovarian reserve. Primary objective To compare ovarian reserve markers and IVF-ICSI laboratory results before and after PRGF infusion. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Low Ovarian Reserve
- What is being tested?
- Plasma Rich in Growth Factors (PRGF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 30 May 2025to May 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women of childbearing age as defined by the CTFG*.
- Women in group 3 and 4 of the POSEIDON classification for low reserve:
- POSEIDON 3: patients ˂ 35 years of age with decreased ovarian reserve (AMH <1.2 ng/ml, AFC <5).
- POSEIDON 4: patients ≥ 35 years with decreased ovarian reserve (AMH <1.2 ng/ml, AFC <5).
- Patients with at least one ovary.
- Infertility of more than 1 year duration.
- Provision of safe ovarian access on the day of the puncture.
- They agree to participate and to give their written consent.
Who cannot join
- Have a diagnosis of clinical ovarian insufficiency - Patients with an ongoing pregnancy - Patients with a clinical diagnosis of ovarian failure
- Patients with ongoing pregnancy
- Current or previous IgA deficiency,
- Ovarian failure secondary to identified genetic causes.
- Presence of pelvic adhesions after abdominal surgery.
- Chronic use of aspirin, NSAIDs or anticoagulants.
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- Diseases that alter platelet number or function.
- Psychiatric disorder that precludes participation in the study (including active substance abuse or dependence).
- Obesity (BMI ≥ 30).
- Current female smokers (≥ 15 cigarettes per day) - Current smoking (≥ 15 cigarettes per day)
- Patients affected by neoplastic disease
- Severe male factor infertility
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Fundación Jiménez Diaz
Madrid, 28924
Eva Cerezo Martín, 915504800, eva.cerezo@quironsalud.es
Carlos Javier Valdera Simbron
About this study
Official title: Open, Non-comparative, Pilot Study to Evaluate the Safety and Efficacy of Intraovarian Growth Factor-rich Plasma in Patients With Low Ovarian Reserve
The use of plasma rich in growth factors (PRGF) improves ovarian reserve markers and IVF laboratory parameters in women with low ovarian reserve.
Primary objective To compare ovarian reserve markers and IVF-ICSI laboratory results before and after PRGF infusion.
Read more
Secondary Objectives
- To compare pre- and post-treatment pregnancy rates.
- To collect complications associated with the application of intraovarian PRGF. General Outline of the Study VISIT 1
- Patient Selection
- Confirm that he/she has all the analyses and variables to be studied.
- Signing of Informed Consent
- Usual IVF protocol (1st IVF cycle) VISIT 2
- Instillation of intraovarian PRGF on the day of the puncture of the 1st IVF cycle in the FJD VISIT 3
- Analytical control at 4 weeks VISIT 4
- Analytical control at 8 weeks VISIT 5
- In case of failure to achieve gestation Start of 2nd cycle of IVF
- Conditions
- Low Ovarian Reserve
- Being tested
- Plasma Rich in Growth Factors (PRGF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma Rich in Growth Factors (PRGF)Biological
On the day of the ovarian puncture of the 1st IVF cycle, intraovarian instillation of plasma rich in growth factors will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Patients starting ovarian stimulation cycle for FIV-ICSI cycle | Experimental | Not described Receives: Biological: Plasma Rich in Growth Factors (PRGF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cycles cancelled pre-puncture
Measured: Day 1
Ovarian reserve markers
Measured: Day 1 vs visit 4 weeks
Number of cycles cancelled post-puncture
Measured: visit 4 weeks and visit 8 weeks
Number of oocytes recovered
Measured: visit 4 weeks and visit 8 weeks
Number of MII (metaphase II stage oocyte) on the day of the puncture
Measured: visit 2, day of the puncture (from the first day of menstruation, approximately 22 days later)
Number of fertilised oocytes
Measured: visit 4 weeks and visit 8 weeks
Number of embryos obtained per EOC (ovarian stimulation) cycle
Measured: visit 4 weeks and visit 8 weeks
Number of embryos of good quality (A or B quality according to ASEBIR classification).
Measured: visit 4 weeks and visit 8 weeks
Number of frozen embryos
Measured: visit 4 weeks and visit 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start30 May 2025
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Ovarian ReserveStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Quasi-Experimental Study with Pre-Post Comparison
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975683
- Sponsor's protocol ID
- URA-PRGF-01
- Other IDs
- 2024-514444-87-00
- Status last verified
- Jun 2025
- First submitted
- 10 Mar 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Non-comparative, Pilot Study to Evaluate the Safety and Efficacy of Intraovarian Growth Factor-rich Plasma in Patients With Low Ovarian Reserve
- ClinicalTrials.gov ID
- NCT06975683
- Acronym / sponsor ID
- URA-PRGF-01
- Conditions
- Low Ovarian Reserve
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 16 May 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.
The use of plasma rich in growth factors (PRGF) improves ovarian reserve markers and IVF laboratory parameters in women with low ovarian reserve.
Primary objective To compare ovarian reserve markers and IVF-ICSI laboratory results before and after PRGF infusion.
Secondary Objectives
- To compare pre- and post-treatment pregnancy rates.
- To collect complications associated with the application of intraovarian PRGF. General Outline of the Study VISIT 1
- Patient Selection
- Confirm that he/she has all the analyses and variables to be studied.
- Signing of Informed Consent
- Usual IVF protocol (1st IVF cycle) VISIT 2
- Instillation of intraovarian PRGF on the day of the puncture of the 1st IVF cycle in the FJD VISIT 3
- Analytical control at 4 weeks VISIT 4
- Analytical control at 8 weeks VISIT 5
- In case of failure to achieve gestation Start of 2nd cycle of IVF
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quasi-Experimental Study with Pre-Post Comparison
| Arm | Type | Receives |
|---|---|---|
| Patients starting ovarian stimulation cycle for FIV-ICSI cycle | Experimental | Biological: Plasma Rich in Growth Factors (PRGF) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Women of childbearing age as defined by the CTFG*.
- Women in group 3 and 4 of the POSEIDON classification for low reserve:
- POSEIDON 3: patients ˂ 35 years of age with decreased ovarian reserve (AMH <1.2 ng/ml, AFC <5).
- POSEIDON 4: patients ≥ 35 years with decreased ovarian reserve (AMH <1.2 ng/ml, AFC <5).
- Patients with at least one ovary.
Key exclusion criteria (12 listed)
- Have a diagnosis of clinical ovarian insufficiency - Patients with an ongoing pregnancy - Patients with a clinical diagnosis of ovarian failure
- Patients with ongoing pregnancy
- Current or previous IgA deficiency,
- Ovarian failure secondary to identified genetic causes.
- Presence of pelvic adhesions after abdominal surgery.
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 |
|---|---|---|
| Plasma Rich in Growth Factors (PRGF)On the day of the ovarian puncture of the 1st IVF cycle, intraovarian instillation of plasma rich in growth factors will be performed. | Biological | Patients starting ovarian stimulation cycle for FIV-ICSI cycle |
Primary outcome
Number of cycles cancelled pre-puncture
Time frame: Day 1
Ovarian reserve markers
Time frame: Day 1 vs visit 4 weeks
Number of cycles cancelled post-puncture
Time frame: visit 4 weeks and visit 8 weeks
Number of oocytes recovered
Time frame: visit 4 weeks and visit 8 weeks
Number of MII (metaphase II stage oocyte) on the day of the puncture
Time frame: visit 2, day of the puncture (from the first day of menstruation, approximately 22 days later)
Number of fertilised oocytes
Time frame: visit 4 weeks and visit 8 weeks
Number of embryos obtained per EOC (ovarian stimulation) cycle
Time frame: visit 4 weeks and visit 8 weeks
Number of embryos of good quality (A or B quality according to ASEBIR classification).
Time frame: visit 4 weeks and visit 8 weeks
Number of frozen embryos
Time frame: visit 4 weeks and visit 8 weeks
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 12 Jun 2025.
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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 Plasma Rich in Growth Factors (PRGF) in people with Low Ovarian Reserve, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
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 8 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: looking for participants now, as of the sponsor's last update on 12 Jun 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 Spain. 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 Carlos Javier Valdera Simbron (915504800 ext. 3274, carlos.valdera@fjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cycles cancelled pre-puncture (time frame: Day 1). The study lists 9 primary outcomes in all. 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 12 Jun 2025.