Poor EndometriumPRPITMNCT03166345
Use of Platelet Rich Plasma (PRP) for Improving Thin Endometrium
A study testing Treatment of Thin Endometrium in people with Poor Endometrium, run by Ibn Sina Hospital at 2 sites in Egypt.
Trial summary
Platelets rich plasma is simple source of growth factors and cytokines that can regulate endometrial growth for subgroup of thin endometrium women. It is an autologous source of this enhancing factors; therefore, there os no risk of using it within the same participant. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Poor Endometrium
- What is being tested?
- Treatment of Thin Endometrium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Aug 2017to 1 Apr 2018
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women with thin endometrium
Who cannot join
- serum positive hepatitis B and C women
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Gannah IVF unit, Gannah Hospital
Giza, 12345
IbnSina IVF Center, IbnSina Hospital
Sohag, 12345
About this study
Official title: Use of Platelet Rich Plasma (PRP) for Improving Thin Endometrium For IVF Women
Platelets rich plasma is simple source of growth factors and cytokines that can regulate endometrial growth for subgroup of thin endometrium women. It is an autologous source of this enhancing factors; therefore, there os no risk of using it within the same participant.
- Conditions
- Poor Endometrium
- Being tested
- Treatment of Thin Endometrium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of Thin EndometriumOther
This is a trial to improve endometrial thickness by autologous injection of PRP into the Uterine Cavity compared with CSF or no treatment.
| Study group | Role | What they receive |
|---|---|---|
| PRP injection into Uterine Cavity | Experimental | PRP injection into Uterine Cavity For Treatment of Thin Endometrium Receives: Other: Treatment of Thin Endometrium |
| CSF (colony stimulating factor) | Experimental | CSF for Treatment of Thin Endometrium Receives: Other: Treatment of Thin Endometrium |
| No intervention | No intervention | The control arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Diameter of endometrial thickness
How the endometrium would respond after 2 days of PRP
Measured: 2 days
Secondary outcomes (1)
Clinical pregnancy rate
Registered fetal heartbeat 4 weeks or beyond after embryo transfer.
Measured: 4 weeks or beyond after 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 May 2017
- Study start15 Aug 2017
- Primary completion30 Mar 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor EndometriumStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibn Sina Hospital
- Sponsor type
- Other government
- Collaborators
- Ganna Hospital
- Responsible party
- Principal investigator, Muhammad Fawzy, Ibn Sina Hospital
- Investigators
- Ayman S El-Gohary, MD, Principal investigator, Ganna Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166345
- Sponsor's protocol ID
- Ibnsina-Ganna-PRP
- Acronym
- PRPITM
- Status last verified
- Jul 2018
- First submitted
- 18 May 2017
- Last updated
- 12 Jul 2018
- 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 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Platelet Rich Plasma (PRP) for Improving Thin Endometrium For IVF Women
- ClinicalTrials.gov ID
- NCT03166345
- Acronym / sponsor ID
- PRPITM / Ibnsina-Ganna-PRP
- Conditions
- Poor Endometrium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ibn Sina HospitalOther government
- Collaborators
- Ganna Hospital
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 25 May 2017 (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.
Platelets rich plasma is simple source of growth factors and cytokines that can regulate endometrial growth for subgroup of thin endometrium women. It is an autologous source of this enhancing factors; therefore, there os no risk of using it within the same participant.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PRP injection into Uterine Cavity | Experimental | Other: Treatment of Thin EndometriumPRP injection into Uterine Cavity For Treatment of Thin Endometrium |
| CSF (colony stimulating factor) | Experimental | Other: Treatment of Thin EndometriumCSF for Treatment of Thin Endometrium |
| No intervention | No intervention | –The control arm. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women with thin endometrium
Key exclusion criteria (1 listed)
- serum positive hepatitis B and C women
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 |
|---|---|---|
| Treatment of Thin EndometriumThis is a trial to improve endometrial thickness by autologous injection of PRP into the Uterine Cavity compared with CSF or no treatment. | Other | CSF (colony stimulating factor), PRP injection into Uterine Cavity |
Primary outcome
Mean Diameter of endometrial thickness
Time frame: 2 days
How the endometrium would respond after 2 days of PRP
1 secondary outcome
Clinical pregnancy rate
Time frame: 4 weeks or beyond after embryo Transfer
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 12 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Poor Endometrium
Recruiting
Application of Platelet-rich Plasma (PRP) in Reproductive Medicine
Premature Ovarian Insufficiency, Intrauterine Adhesion
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.
Ayman S El-Gohary, MD principal investigator
Ganna Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment of Thin Endometrium in people with Poor Endometrium, run by Ibn Sina Hospital at 2 sites in Egypt.
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: finished, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
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?
Mean Diameter of endometrial thickness (time frame: 2 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 12 Jul 2018.