Endometrial DevelopmentPhase 3NCT02996760
Influence Instillation Plasma Rich in Growth Factors in Endometrial Cavity Endometrial Development in Assisted Reproduction.
A Phase 3 study testing Growth Factor, Platelet-Derived in people with Endometrial Development, run by IVI Bilbao at 1 site in Spain.
Trial summary
Women in assisted reproduction treatment they receive own or donated embryos and presenting an endometrial development less than 5 mm despite having received treatment with estrogen therapy knowing the clinical value of using the PRGF-Endoret therapy and endometrial level applications to improve endometrial thickness… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Endometrial Development
- What is being tested?
- Growth Factor, Platelet-Derived
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSpain
- Study dates
- 14 Mar 2018to 31 Dec 2021
- 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 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women receiving cycle of oocytes outside or embryos (own / others), in the treatment of substituted cycle type.
- Less than 5mm despite 10 days with standard doses of estrogen therapy (6mg / 24h) Endometrio
Who cannot join
- History of pelvic inflammatory disease
- Risk of infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence Instillation Plasma Rich in Growth Factors in Endometrial Cavity
Women in assisted reproduction treatment they receive own or donated embryos and presenting an endometrial development less than 5 mm despite having received treatment with estrogen therapy knowing the clinical value of using the PRGF-Endoret therapy and endometrial level applications to improve endometrial thickness endometrial preparations for embryo transfer.
- Conditions
- Endometrial Development
- Being tested
- Growth Factor, Platelet-Derived
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth Factor, Platelet-DerivedDrug
0,5 mL, vaginal use , 3 dose number
| Study group | Role | What they receive |
|---|---|---|
| Endometrium with less than 5mm | Experimental | Women receiving cycle of oocytes outside or embryos (own / others), in the treatment of substituted cycle type.
Less than 5mm despite 10 days with standard doses of estrogen Receives: Drug: Growth Factor, Platelet-Derived |
| Endometrium with more than 5mm | No intervention | Women receiving cycle of oocytes outside or embryos (own / others), in the treatment of substituted cycle type. More than 5mm despite 10 days with standard doses of estrogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the growth of endometrial thickness
The endometrial thickness will be measured by vaginal ultrasound. Endometrium less than 5 mm will be treated
Measured: During ovarian stimulation protocol 8-12 days
Secondary outcomes (1)
Analyze the impact of using platelet plasma on rates of implantation and pregnancy.
The biochemical determination of the hormone ßhcg will be performed 12 days after embryo transfer
Measured: During ovarian stimulation protocol 8-12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study start14 Mar 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Why it stopped: difficulty in recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial DevelopmentStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT02996760
- Sponsor's protocol ID
- 1404-BIO-019-MF
- Status last verified
- Mar 2022
- First submitted
- 2 Dec 2016
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence Instillation Plasma Rich in Growth Factors in Endometrial Cavity
- ClinicalTrials.gov ID
- NCT02996760
- Acronym / sponsor ID
- 1404-BIO-019-MF
- Conditions
- Endometrial Development
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty in recruiting
- Enrolment
- 22 participants (actual)
- Lead sponsor
- IVI BilbaoUniversity, hospital or other
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 19 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.
Women in assisted reproduction treatment they receive own or donated embryos and presenting an endometrial development less than 5 mm despite having received treatment with estrogen therapy knowing the clinical value of using the PRGF-Endoret therapy and endometrial level applications to improve endometrial thickness endometrial preparations for embryo transfer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometrium with less than 5mm | Experimental | Drug: Growth Factor, Platelet-DerivedWomen receiving cycle of oocytes outside or embryos (own / others), in the treatment of substituted cycle type. Less than 5mm despite 10 days with standard doses of estrogen |
| Endometrium with more than 5mm | No intervention | –Women receiving cycle of oocytes outside or embryos (own / others), in the treatment of substituted cycle type. More than 5mm despite 10 days with standard doses of estrogen |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women receiving cycle of oocytes outside or embryos (own / others), in the treatment of substituted cycle type.
- Less than 5mm despite 10 days with standard doses of estrogen therapy (6mg / 24h) Endometrio
Key exclusion criteria (2 listed)
- History of pelvic inflammatory disease
- Risk of infection
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 Factor, Platelet-Derived0,5 mL, vaginal use , 3 dose number | Drug | Endometrium with less than 5mm |
Primary outcome
To evaluate the growth of endometrial thickness
Time frame: During ovarian stimulation protocol 8-12 days
The endometrial thickness will be measured by vaginal ultrasound. Endometrium less than 5 mm will be treated
1 secondary outcome
Analyze the impact of using platelet plasma on rates of implantation and pregnancy.
Time frame: During ovarian stimulation protocol 8-12 days
Results and safety
The study was stopped early (reason given: difficulty in recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
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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 Factor, Platelet-Derived in people with Endometrial Development, 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 2 inclusion and 2 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 7 Apr 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 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: difficulty in recruiting). 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?
To evaluate the growth of endometrial thickness (time frame: During ovarian stimulation protocol 8-12 days). 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 7 Apr 2022.