InfertilityPhase 2APTENCT03387501
Concentrate of Autologous Rich Plasma in Growth Factors in the Treatment of the Thin Endometrium
A Phase 2 study testing Plasma rich in growth factors (PRGF-Endoret) in people with Infertility and Infertility, Female, run by Sara Rafael Fernandez at 1 site in Spain.
Trial summary
This study evaluate the percentage of women with thin endometrium who achieve an endometrial thickness equal to or greater than 7 mm after administration of PRGF (plasma rich in growth factors) Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility, Infertility, Female
- What is being tested?
- Plasma rich in growth factors (PRGF-Endoret)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSpain
- Study dates
- 27 May 2019to 26 Jul 2022
- Phase
- Phase 2
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who signed informed consent.
- Women who understand the Spanish language.
- Women under 42 years
Who cannot join
- Thrombopenia.
- Congenital or acquired uterine malformations that reduce embryo implantation or term gestation.
- Ovarian tumors.
- Benign uterine tumors require surgical treatment
- Local acute inflammatory diseases
- Patients with malignant tumors requiring chemotherapy.
- Patients with acute or chronic infectious or inflammatory diseases requiring active treatment with drugs that may interfere with implantation and gestation.
- Chronic treatment with NSAIDs (Nonsteroidal anti-inflammatory drugs)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of the Concentrate of Autologous Rich Plasma in Growth Factors in the Treatment of the Thin Endometrium in Patients Undergoing Transfer of Cryo-preserved Embryos: Clinical Trial II.
This study evaluate the percentage of women with thin endometrium who achieve an endometrial thickness equal to or greater than 7 mm after administration of PRGF (plasma rich in growth factors)
- Conditions
- Infertility, Infertility, Female
- Being tested
- Plasma rich in growth factors (PRGF-Endoret)
- Medical subject headings
- Infertility, Infertility, Female
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-Endoret)Drug
Intrauterine administration of PRGF
| Study group | Role | What they receive |
|---|---|---|
| PRGF | Experimental | Plasma rich in growth factors (PRGF) administration Receives: Drug: Plasma rich in growth factors (PRGF-Endoret) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of women who achieve an endometrial thickness equal to or greater than 7 mm
Measurement of the endometrial thickness by ultrasonography.
Measured: 3 days after administration of PRGF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start27 May 2019
- Primary completion26 Jul 2022
- Study completion26 Jul 2022
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara Rafael Fernandez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sara Rafael Fernandez, Hospital San Carlos, Madrid
- Investigators
- Sara Rafael, PhD, Study chair, Hospital Clinico San Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387501
- Sponsor's protocol ID
- APTE
- Acronym
- APTE
- Status last verified
- Sep 2022
- First submitted
- 22 Dec 2017
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Concentrate of Autologous Rich Plasma in Growth Factors in the Treatment of the Thin Endometrium in Patients Undergoing Transfer of Cryo-preserved Embryos: Clinical Trial II.
- ClinicalTrials.gov ID
- NCT03387501
- Acronym / sponsor ID
- APTE / APTE
- Conditions
- Infertility, Infertility, Female
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Sara Rafael FernandezUniversity, hospital or other
- Study start
- 27 May 2019 (actual)
- Primary completion
- 26 Jul 2022 (actual)
- Study completion
- 26 Jul 2022 (actual)
- First posted
- 2 Jan 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.
This study evaluate the percentage of women with thin endometrium who achieve an endometrial thickness equal to or greater than 7 mm after administration of PRGF (plasma rich in 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 |
|---|---|---|
| PRGF | Experimental | Drug: Plasma rich in growth factors (PRGF-Endoret)Plasma rich in growth factors (PRGF) administration |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women who signed informed consent.
- Women who understand the Spanish language.
- Women under 42 years
Key exclusion criteria (8 listed)
- Thrombopenia.
- Congenital or acquired uterine malformations that reduce embryo implantation or term gestation.
- Ovarian tumors.
- Benign uterine tumors require surgical treatment
- Local acute inflammatory diseases
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-Endoret)Intrauterine administration of PRGF | Drug | PRGF |
Primary outcome
Percentage of women who achieve an endometrial thickness equal to or greater than 7 mm
Time frame: 3 days after administration of PRGF
Measurement of the endometrial thickness by ultrasonography.
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 8 Sep 2022.
- 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.
Sara Rafael, PhD study chair
Hospital Clinico San Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Plasma rich in growth factors (PRGF-Endoret) in people with Infertility and Infertility, Female, run by Sara Rafael Fernandez 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 3 inclusion and 8 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 8 Sep 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Percentage of women who achieve an endometrial thickness equal to or greater than 7 mm (time frame: 3 days after administration of PRGF). 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 8 Sep 2022.