InfertilityPhase 2PRP-ENCT02825849
Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair
A Phase 2 study testing Intrauterine infusion of platelet rich plasma in people with Infertility and Asherman's Syndrome, run by University of California, San Francisco at 1 site in United States.
Trial summary
Patients with intrauterine adhesions (Asherman's Syndrome) and persistent thin endometrial lining in in vitro fertilization (IVF) treatment programs, particularly those resistant to standard therapies, present a significant clinical challenge. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Asherman's Syndrome
- What is being tested?
- Intrauterine infusion of platelet rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Aug 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Persistent thin lining < 6mm on >1 cycle in previous IVF or FET cycle OR moderate-to-severe Asherman's syndrome
Who cannot join
- Age <18 years old or >43 years old,
- Pregnancy,
- Diagnosis of cancer,
- Hb <11 g/dL, platelets <150,000/mm3,
- Anticoagulation,
- NSAIDs in the 10 days before procedure
- Any significant comorbidity or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
- Incision in the uterus: myomectomy; cesarean section
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco - Center for Reproductive Health
San Francisco, California, 94158
About this study
Official title: Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair: a Prospective Randomised Pilot Study
Patients with intrauterine adhesions (Asherman's Syndrome) and persistent thin endometrial lining in in vitro fertilization (IVF) treatment programs, particularly those resistant to standard therapies, present a significant clinical challenge. The aim of this trial is to assess if intrauterine administration of platelet rich plasma (PRP) improves endometrial lining thickness in patients with thin lining or Asherman's Syndrome.
Read the detailed description
BACKGROUND:
There is a need for new and more effective therapies for patients with intrauterine adhesions (Asherman's Syndrome) and persistent thin endometrial lining in in vitro fertilization (IVF) treatment programs, particularly for patients resistant to standard therapies
HYPOTHESIS:
Platelet rich plasma stimulates cellular processes involved in endometrial regeneration relevant to management of a thin lining or intrauterine scarring.
PRIMARY AIMS:
- To measure the change in endometrial lining thickness
SECONDARY AIMS:
- To determine if fertility is improved in patients receiving platelet rich plasma (PRP):
- In patients with thin lining undergoing frozen embryo transfer (FET), to determine:
- clinical pregnancy rate
- In patients with Asherman's Syndrome, to determine:
- the chance of spontaneous pregnancy
Any adverse effects of study arm will be monitored and reported as appropriate.
- Conditions
- Infertility, Asherman's Syndrome
- Being tested
- Intrauterine infusion of platelet rich plasma
- Keywords
- endometrium, thin uterine lining, uterine scarring
- Medical subject headings
- Infertility, Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine infusion of platelet rich plasmaBiological
Also called PRP
Patients randomized to study group will have 30cc of blood drawn with isolation of platelet rich plasma (PRP) per standard manufacturer's protocol, with subsequent intrauterine infusion of this autologous PRP.
| Study group | Role | What they receive |
|---|---|---|
| PRP intrauterine infusion | Experimental | Intrauterine infusion of platelet rich plasma in combination with standard treatment, in patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles Receives: Biological: Intrauterine infusion of platelet rich plasma |
| Control group with standard treatment only | No intervention | Patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles undergoing standard treatment protocols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial Thickness
Endometrial thickness will be measured using transvaginal ultrasound per standard protocol
Measured: 3-30 days after treatment
Secondary outcomes (1)
Number of Participants With Ultrasound Confirmed Clinical Pregnancies
Defined by ultrasound confirmed pregnancies per total participants in each arm
Measured: at least 7 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startNov 2016
- Primary completionAug 2019
- Study completionAug 2019
Why it stopped: Low recruitment and competing studies have published.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- During Study Period #1: Subjects were randomized to receive either PRP or standard care. A total of 13 subjects were randomized. The study design was then altered to remove randomization (10/4/2018). All patients in Study Period #2 received PRP. An additional 14 subjects were enrolled in Study Period #2.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather G. Huddleston, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825849
- Sponsor's protocol ID
- 16-19764
- Acronym
- PRP-E
- Status last verified
- Jan 2021
- First submitted
- 3 Jul 2016
- Last updated
- 9 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair: a Prospective Randomised Pilot Study
- ClinicalTrials.gov ID
- NCT02825849
- Acronym / sponsor ID
- PRP-E / 16-19764
- Conditions
- Infertility, Asherman's Syndrome
- Keywords
- endometrium, thin uterine lining, uterine scarring
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment and competing studies have published.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Posted 9 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with intrauterine adhesions (Asherman's Syndrome) and persistent thin endometrial lining in in vitro fertilization (IVF) treatment programs, particularly those resistant to standard therapies, present a significant clinical challenge. The aim of this trial is to assess if intrauterine administration of platelet rich plasma (PRP) improves endometrial lining thickness in patients with thin lining or Asherman's Syndrome.
Detailed description
BACKGROUND:
There is a need for new and more effective therapies for patients with intrauterine adhesions (Asherman's Syndrome) and persistent thin endometrial lining in in vitro fertilization (IVF) treatment programs, particularly for patients resistant to standard therapies
HYPOTHESIS:
Platelet rich plasma stimulates cellular processes involved in endometrial regeneration relevant to management of a thin lining or intrauterine scarring.
PRIMARY AIMS:
- To measure the change in endometrial lining thickness
SECONDARY AIMS:
- To determine if fertility is improved in patients receiving platelet rich plasma (PRP):
- In patients with thin lining undergoing frozen embryo transfer (FET), to determine:
- clinical pregnancy rate
- In patients with Asherman's Syndrome, to determine:
- the chance of spontaneous pregnancy
Any adverse effects of study arm will be monitored and reported as appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- During Study Period #1: Subjects were randomized to receive either PRP or standard care. A total of 13 subjects were randomized. The study design was then altered to remove randomization (10/4/2018). All patients in Study Period #2 received PRP. An additional 14 subjects were enrolled in Study Period #2.
| Arm | Type | Receives |
|---|---|---|
| PRP intrauterine infusion | Experimental | Biological: Intrauterine infusion of platelet rich plasmaIntrauterine infusion of platelet rich plasma in combination with standard treatment, in patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles |
| Control group with standard treatment only | No intervention | –Patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles undergoing standard treatment protocols |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Persistent thin lining < 6mm on >1 cycle in previous IVF or FET cycle OR moderate-to-severe Asherman's syndrome
Key exclusion criteria (8 listed)
- Age <18 years old or >43 years old,
- Pregnancy,
- Diagnosis of cancer,
- Hb <11 g/dL, platelets <150,000/mm3,
- Anticoagulation,
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 |
|---|---|---|
| Intrauterine infusion of platelet rich plasmaAlso: PRPPatients randomized to study group will have 30cc of blood drawn with isolation of platelet rich plasma (PRP) per standard manufacturer's protocol, with subsequent intrauterine infusion of this autologous PRP. | Biological | PRP intrauterine infusion |
Primary outcome
Endometrial Thickness
Time frame: 3-30 days after treatment
Endometrial thickness will be measured using transvaginal ultrasound per standard protocol
1 secondary outcome
Number of Participants With Ultrasound Confirmed Clinical Pregnancies
Time frame: at least 7 weeks after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Heather G. Huddleston, MD principal investigator
University of California, San Francisco
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 Intrauterine infusion of platelet rich plasma in people with Infertility and Asherman's Syndrome, run by University of California, San Francisco at 1 site in United States.
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 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: stopped early, as of the sponsor's last update on 9 Feb 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 9 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Endometrial Thickness (time frame: 3-30 days after treatment). 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 9 Feb 2021.