Low Ovarian ReservePhase 3PRGFO-2020NCT02992756
Influence of PRGF (Plasma Rich in Growth Factors) Puncture in Ovaries With Low Follicular Reservetechniques
A Phase 3 study testing Growth Factors in people with Low Ovarian Reserve, run by IVI Bilbao at 1 site in Spain.
Trial summary
Assisted reproduction patients candidates to an IVF/ICSI cycle with low follicular reserve: after at least one cycle of stimulation obtaining 0-4 oocytes. Improve the follicular response in patients with low response, increasing the number of follicles in subsequent cycles to treatment with growth factors. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Low Ovarian Reserve
- What is being tested?
- Growth Factors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSpain
- Study dates
- 29 Jun 2021to 31 Dec 2024
- Phase
- Phase 3
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients must give written consent.
- To be a healthy woman acting voluntarily, aged 18 to 42 years (both inclusive) at the time of study selection time of selection for the study.
- Have a BMI ≥ 18 kg/m2 and ≤ 35 kg/m2
- Patients with low ovarian reserve (AMH <1.1 ng/mL) according to the Bologna criteria.
- Patients who are going to undergo IVF/ICSI cycle with low follicular response: who after a previous cycle of stimulation have obtained 0-3 or more follicular 0-3 oocytes have been obtained after a previous stimulation cycle; or if 0-3 oocytes are expected to be obtained at the present time (less than 4 follicles).
- oocytes (less than 4 follicles in the basal ultrasound).
- To have recent analytical results (haemogram, biochemistry and coagulation); at least 11 months prior to inclusion in the study and a serology, according to clinical practice.
- Translated with www.DeepL.com/Translator (free version)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of PRGF (Plasma Rich in Growth Factors) Puncture in Ovaries With Low Follicular Reserve
Assisted reproduction patients candidates to an IVF/ICSI cycle with low follicular reserve: after at least one cycle of stimulation obtaining 0-4 oocytes.
Improve the follicular response in patients with low response, increasing the number of follicles in subsequent cycles to treatment with growth factors.
- Conditions
- Low Ovarian Reserve
- Being tested
- Growth Factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth FactorsDrug
one dose 3-6 mL of PRP obtained by PRGF Endoret
| Study group | Role | What they receive |
|---|---|---|
| Instillation of growth factors | Experimental | Patients candidates to an IVF/ICSI cycle with low follicular reserve: after at least one cycle of stimulation obtaining 0-3 oocytes. Receives: Drug: Growth Factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of follicles recruited after instability of ovarian growth factors
- demonstrate an increase of at least 20% in the number of MII oocytes in a cycle after IVF/ICSI treatment with PRGF®-Endoret® compared to previous cycles in low IVF/ICSI patients.
IVF/ICSI treatment with PRGF®-Endoret® with respect to previous cycles in low responders.
responders
Measured: two months; Time included in two protocols of ovarian stimulation
Secondary outcomes (1)
Rates of pregnancy rates
Increase pregnancy rates and decrease the number of cycles of accumulation of oocytes.
Measured: three months after embryo transfer after treatment of growth factors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study start29 Jun 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Why it stopped: Due to the difficulty in meeting the selection criteria by preventing continued recruitment to the trial. This has made recruitment more difficult and has prolonged the recruitment time to more than two years from the initially planned end of study
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Bilbao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992756
- Sponsor's protocol ID
- 1607-BIO-057-MF
- Acronym
- PRGFO-2020
- Status last verified
- Apr 2025
- First submitted
- 2 Dec 2016
- Last updated
- 2 May 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 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of PRGF (Plasma Rich in Growth Factors) Puncture in Ovaries With Low Follicular Reserve
- ClinicalTrials.gov ID
- NCT02992756
- Acronym / sponsor ID
- PRGFO-2020 / 1607-BIO-057-MF
- Conditions
- Low Ovarian Reserve
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the difficulty in meeting the selection criteria by preventing continued recruitment to the trial. This has made recruitment more difficult and has prolonged the recruitment time to more than two years from the initially planned end of study
- Enrolment
- 51 participants (actual)
- Lead sponsor
- IVI BilbaoUniversity, hospital or other
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 14 Dec 2016 (estimated)
- 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.
Assisted reproduction patients candidates to an IVF/ICSI cycle with low follicular reserve: after at least one cycle of stimulation obtaining 0-4 oocytes.
Improve the follicular response in patients with low response, increasing the number of follicles in subsequent cycles to treatment with growth factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Instillation of growth factors | Experimental | Drug: Growth FactorsPatients candidates to an IVF/ICSI cycle with low follicular reserve: after at least one cycle of stimulation obtaining 0-3 oocytes. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients must give written consent.
- To be a healthy woman acting voluntarily, aged 18 to 42 years (both inclusive) at the time of study selection time of selection for the study.
- Have a BMI ≥ 18 kg/m2 and ≤ 35 kg/m2
- Patients with low ovarian reserve (AMH <1.1 ng/mL) according to the Bologna criteria.
- Patients who are going to undergo IVF/ICSI cycle with low follicular response: who after a previous cycle of stimulation have obtained 0-3 or more follicular 0-3 oocytes have been obtained after a previous stimulation cycle; or if 0-3 oocytes are expected to be obtained at the present time (less than 4 follicles).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Growth Factorsone dose 3-6 mL of PRP obtained by PRGF Endoret | Drug | Instillation of growth factors |
Primary outcome
Number of follicles recruited after instability of ovarian growth factors
Time frame: two months; Time included in two protocols of ovarian stimulation
o demonstrate an increase of at least 20% in the number of MII oocytes in a cycle after IVF/ICSI treatment with PRGF®-Endoret® compared to previous cycles in low IVF/ICSI patients. IVF/ICSI treatment with PRGF®-Endoret® with respect to previous cycles in low responders. responders
1 secondary outcome
Rates of pregnancy rates
Time frame: three months after embryo transfer after treatment of growth factors
Results and safety
The study was stopped early (reason given: Due to the difficulty in meeting the selection criteria by preventing continued recruitment to the trial. This has made recruitment more difficult and has prolonged the recruitment time to more than two years from the initially planned end of study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Growth Factors in people with Low Ovarian Reserve, run by IVI Bilbao 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 0 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: stopped early, as of the sponsor's last update on 2 May 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to the difficulty in meeting the selection criteria by preventing continued recruitment to the trial. This has made recruitment more difficult and has prolonged the recruitment time to more than two years from the initially planned end of study). Results are not available in the source record.
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 follicles recruited after instability of ovarian growth factors (time frame: two months; Time included in two protocols of ovarian stimulation). 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 2 May 2025.