InfertilityPhase 1/2NCT02660294
Intrauterine Autologous PRP Infusion Compared to HRT for Enhancing Endometrial Thickness in Patients Undergoing ICSI
A Phase 1/2 study testing platlet rich plasma in people with Infertility, run by Ain Shams University at 1 site in Egypt.
Trial summary
Successful embryo implantation needs an optimum embryonic development with a receptive endometrium. Endometrial thickness is an independant factor for endometrial receiptivity. The aim of that trial is to assess the benefecial effect of platelt rich plasma in copmarison with standard hormonal therapy. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- platlet rich plasma
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2016to Apr 2017
- Phase
- Phase 1/2
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients undergoing ICSI
- endometrial thickness less than 7 mm on early follicular phase
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Rasha
Cairo, Cairo Governorate
Rasha M Abdul-hady, MD, 1224448449 ext. 0020, rashamedhat30@gmail.com
ahmed M kotb, MD, 1004711414 ext. 0020, ahmedmkotp@hotmail.com
About this study
Official title: Intrauterine Autologous Platelet -Enriched Plasma Infusion Compared to Hormonal Replacement Therapy for Enhancing Endometrial Thickness in Patients Undergoing ICSI
Successful embryo implantation needs an optimum embryonic development with a receptive endometrium. Endometrial thickness is an independant factor for endometrial receiptivity. The aim of that trial is to assess the benefecial effect of platelt rich plasma in copmarison with standard hormonal therapy.
Read the detailed description
This is a single blinded randomized trial comparing the effect of of platlet rich plasma versus hormonal therapy on endometrial thickness and consequently endometrial receptivity. The primary endpoint of this trial is clinical pregnancy rate.
- Conditions
- Infertility
- Being tested
- platlet rich plasma
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platlet rich plasmaBiological
Platelet-rich plasma (PRP) is prepared from fresh whole blood which is collected from a peripheral vein, stored in acid citrate dextrose solution A (ACD-A) anticoagulant and processed to increase platelets by separating various components of blood
| Study group | Role | What they receive |
|---|---|---|
| Platlet rich plasma | Experimental | For those with endometrial thickness less than 7 mm intrauterine injection of platlet rich plasma (PRP) for enhancing endometrial thickness and receptivity Receives: Biological: platlet rich plasma |
| Hormone replacement therapy | No intervention | Oral intake of estradiol valerate for those with endometrial thickness less than 7 mm will improve endometrial receptivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
endometrial thickness in mm
using transvaginal ultrasound to measure endometrial thickness in mm
Measured: 72 hours
Secondary outcomes (1)
clinical pregnancy rate
using transvaginal ultrasound to detect fetal cardiac activity
Measured: 4 weeks 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 posted21 Jan 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017 (estimated)
- Study completionApr 2017 (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 Ain Shams UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rasha medhat abdul-hady, Ain Shams University
- Investigators
- RASHA DR MEDHAT, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660294
- Sponsor's protocol ID
- PRP-IVF
- Status last verified
- Mar 2016
- First submitted
- 16 Jan 2016
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrauterine Autologous Platelet -Enriched Plasma Infusion Compared to Hormonal Replacement Therapy for Enhancing Endometrial Thickness in Patients Undergoing ICSI
- ClinicalTrials.gov ID
- NCT02660294
- Acronym / sponsor ID
- PRP-IVF
- Conditions
- Infertility
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 21 Jan 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.
Successful embryo implantation needs an optimum embryonic development with a receptive endometrium. Endometrial thickness is an independant factor for endometrial receiptivity. The aim of that trial is to assess the benefecial effect of platelt rich plasma in copmarison with standard hormonal therapy.
Detailed description
This is a single blinded randomized trial comparing the effect of of platlet rich plasma versus hormonal therapy on endometrial thickness and consequently endometrial receptivity. The primary endpoint of this trial is clinical pregnancy rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platlet rich plasma | Experimental | Biological: platlet rich plasmaFor those with endometrial thickness less than 7 mm intrauterine injection of platlet rich plasma (PRP) for enhancing endometrial thickness and receptivity |
| Hormone replacement therapy | No intervention | –Oral intake of estradiol valerate for those with endometrial thickness less than 7 mm will improve endometrial receptivity |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients undergoing ICSI
- endometrial thickness less than 7 mm on early follicular phase
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| platlet rich plasmaPlatelet-rich plasma (PRP) is prepared from fresh whole blood which is collected from a peripheral vein, stored in acid citrate dextrose solution A (ACD-A) anticoagulant and processed to increase platelets by separating various components of blood | Biological | Platlet rich plasma |
Primary outcome
endometrial thickness in mm
Time frame: 72 hours
using transvaginal ultrasound to measure endometrial thickness in mm
1 secondary outcome
clinical pregnancy rate
Time frame: 4 weeks after embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
RASHA DR MEDHAT, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing platlet rich plasma in people with Infertility, run by Ain Shams University at 1 site 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 2 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 22 Mar 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 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact rasha Dr medhat, MD (1224448449 ext. 0020, RASHAMEDHAT30@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endometrial thickness in mm (time frame: 72 hours). 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 22 Mar 2016.