InfertilityNCT04354363
PRP in Intracytoplasmic Sperm Injection
A study testing Platelet rich plasma in people with Infertility, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
Infertility is a major problem nowadays Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Platelet rich plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Apr 2020to 1 Mar 2021
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- women with primary infertility
Who cannot join
- women with unexplained infertility
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Algazeerah
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
About this study
Official title: Role of PRP in Intracytoplasmic Sperm Injection in Infertile Women
Infertility is a major problem nowadays
Read the detailed description
ovarian and uterine factor of infertility are very hard to treat
- Conditions
- Infertility
- Being tested
- Platelet 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.
Platelet rich plasmaOther
Giving women PRP before ICSI
| Study group | Role | What they receive |
|---|---|---|
| PRP | Active comparator | women who will receive PRP before ICSI Receives: Other: Platelet rich plasma |
| No PRP | No intervention | women who willnot receive PRP before ICSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of women wo will have chemical pregnancy
how many women will have chemical pregnancy
Measured: within 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start22 Apr 2020 (estimated)
- Primary completion15 Feb 2021 (estimated)
- Study completion1 Mar 2021 (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.
- 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
- Model description
- A randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud Alalfy, PhD, Study chair, Algezeera hospitaland National Research Centre ,Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354363
- Sponsor's protocol ID
- ICSI in poor reserve
- Status last verified
- Apr 2020
- First submitted
- 17 Apr 2020
- Last updated
- 21 Apr 2020
- 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 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of PRP in Intracytoplasmic Sperm Injection in Infertile Women
- ClinicalTrials.gov ID
- NCT04354363
- Acronym / sponsor ID
- ICSI in poor reserve
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Study start
- 22 Apr 2020 (estimated)
- Primary completion
- 15 Feb 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 21 Apr 2020 (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.
Infertility is a major problem nowadays
Detailed description
ovarian and uterine factor of infertility are very hard to treat
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| PRP | Active comparator | Other: Platelet rich plasmawomen who will receive PRP before ICSI |
| No PRP | No intervention | –women who willnot receive PRP before ICSI |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women with primary infertility
Key exclusion criteria (1 listed)
- women with unexplained infertility
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 |
|---|---|---|
| Platelet rich plasmaGiving women PRP before ICSI | Other | PRP |
Primary outcome
The number of women wo will have chemical pregnancy
Time frame: within 3 months
how many women will have chemical pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
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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.
Mahmoud Alalfy, PhD study chair
Algezeera hospitaland National Research Centre ,Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet rich plasma in people with Infertility, run by Aljazeera Hospital 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 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 21 Apr 2020. 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.
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 Mahmoud Alalfy, PhD (01002611058, mahmoudalalfy@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of women wo will have chemical pregnancy (time frame: within 3 months). 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 21 Apr 2020.