InfertilityNCT02973555
Platelet-Rich Protein and the Endometrium
A study testing PRP injection in people with Infertility, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Platelet-rich plasma (PRP) may promote the endometrial growth and improve pregnancy outcome of patients with thin endometrium undergoing ART treatments. Read more about this study
- Who is it for?
- Ages 18 to 54 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- PRP injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2017to Jan 2019
- 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 54 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women undergoing a frozen thawed embryo transfer cycle with poor endometrial response to estrogen (< 7 mm) after at least two standard preparation protocols, of which one was canceled due to thin endometrium
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Platelet-rich Plasma (PRP) Promote Endometrial Growth and Improve Pregnancy Outcome of Patients With Thin Endometrium Undergoing Assisted Reproductive Technology (ART) Treatments?
Platelet-rich plasma (PRP) may promote the endometrial growth and improve pregnancy outcome of patients with thin endometrium undergoing ART treatments.
- Conditions
- Infertility
- Being tested
- PRP injection
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP injectionOther
autologous intrauterine infusion of PRP
| Study group | Role | What they receive |
|---|---|---|
| PRP injection | Experimental | Not described Receives: Other: PRP injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
endometrial thickness >7mm
Measured: 1 month
Secondary outcomes (1)
Positive serum pregnancy test
Measured: 14 days post embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2018 (estimated)
- Study completionJan 2019 (estimated)
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.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronit Kochman, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973555
- Sponsor's protocol ID
- PRP-HMO-CTIL
- Status last verified
- Nov 2016
- First submitted
- 22 Nov 2016
- Last updated
- 25 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Platelet-rich Plasma (PRP) Promote Endometrial Growth and Improve Pregnancy Outcome of Patients With Thin Endometrium Undergoing Assisted Reproductive Technology (ART) Treatments?
- ClinicalTrials.gov ID
- NCT02973555
- Acronym / sponsor ID
- PRP-HMO-CTIL
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 25 Nov 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.
Platelet-rich plasma (PRP) may promote the endometrial growth and improve pregnancy outcome of patients with thin endometrium undergoing ART treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRP injection | Experimental | Other: PRP injection |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women undergoing a frozen thawed embryo transfer cycle with poor endometrial response to estrogen (< 7 mm) after at least two standard preparation protocols, of which one was canceled due to thin endometrium
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| PRP injectionautologous intrauterine infusion of PRP | Other | PRP injection |
Primary outcome
endometrial thickness >7mm
Time frame: 1 month
1 secondary outcome
Positive serum pregnancy test
Time frame: 14 days post embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2016.
- 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.
Ronit Kochman, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP injection in people with Infertility, run by Hadassah Medical Organization at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Nov 2016. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronit Kochman, MD (+972 508946414, kochman@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endometrial thickness >7mm (time frame: 1 month). 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 25 Nov 2016.