Poor RespondersNCT06663930
New Approach for Ovarian PRP Injection for Poor Responders
An observational study of Poor Responders, run by Bassem Ayman Mahmoud Assaf at 1 site in Egypt.
Trial summary
New Approach For Ovarian PRP Injection for poor responders Read more about this study
- Who is it for?
- Ages 30 to 40 years, women only
- Conditions the study is for
- Poor Responders
- How many people
- 21 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 30 Jun 2025
- Phase
- Observational
- 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 30 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: women attending their attempt of IVF/ICSI at Assaf Fertility center, after poor ovarian response in a previous trial, during the period March 2024 to June 2025
Who may be able to join
- AMH : < 0.5 ng/ml
- FSH: > 10 miu but < 25 miu.
- AFC : < 5 in both ovaries
- Poor ovarian response, in a previous IVF/ICSI trial , resulting in 3 or fewer oocytes.
- Normal uterine cavity , demonstrated by a recent hysteroscopy
Who cannot join
- Primary ovarian insufficiency with FSH > 25 miu.
- Previous ovarian surgery or Chemotherapy.
- On going Anticoagulant use.
- Carcinomas or a history of chronic pelvic pain.
- Present infection.
- Hemoglobin level lower than 11 g/L
- platelet count lower than 150 x 10³/μL.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: New Approach for Ovarian PRP Injection for Poor Responders ; Aiming At the Highest Response Rate
New Approach For Ovarian PRP Injection for poor responders
Read the detailed description
Poor ovarian responders are at high risk of unsuccessful IVF/ICSI trials. In the last few years, many studies showed significant improvement of ovarian reserve parameters after PRP injection. There was no consensus regarding the route of injection, the volume injected, the location of PRP injection inside the ovary, the number of injection and the number of the cycle in which PRP is injected.
- Conditions
- Poor Responders
What is being measured
The primary outcome is the main question the study is designed to answer.
PRP effect on ovary for better fertility outcome
This is a prospective cohort clinical observational study. Aiming at evaluating the clinical effects of injecting PRP(Platelet Rich Plasma) into ovaries, of poor responders, taking all measures which may improve the response rate. That is why we will inject PRP for 2 consecutive cycles, the first cycle via laparoscopy and the next cycle, via ultrasonography.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Mar 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor RespondersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bassem Ayman Mahmoud Assaf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bassem Ayman Mahmoud Assaf, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663930
- Sponsor's protocol ID
- New Approach For Ovarian PRP
- Status last verified
- Oct 2024
- First submitted
- 19 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Approach for Ovarian PRP Injection for Poor Responders ; Aiming At the Highest Response Rate
- ClinicalTrials.gov ID
- NCT06663930
- Acronym / sponsor ID
- New Approach For Ovarian PRP
- Conditions
- Poor Responders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Bassem Ayman Mahmoud AssafUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 29 Oct 2024 (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.
New Approach For Ovarian PRP Injection for poor responders
Detailed description
Poor ovarian responders are at high risk of unsuccessful IVF/ICSI trials. In the last few years, many studies showed significant improvement of ovarian reserve parameters after PRP injection. There was no consensus regarding the route of injection, the volume injected, the location of PRP injection inside the ovary, the number of injection and the number of the cycle in which PRP is injected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- women attending their attempt of IVF/ICSI at Assaf Fertility center, after poor ovarian response in a previous trial, during the period March 2024 to June 2025
Key inclusion criteria (5 listed)
- AMH : < 0.5 ng/ml
- FSH: > 10 miu but < 25 miu.
- AFC : < 5 in both ovaries
- Poor ovarian response, in a previous IVF/ICSI trial , resulting in 3 or fewer oocytes.
- Normal uterine cavity , demonstrated by a recent hysteroscopy
Key exclusion criteria (7 listed)
- Primary ovarian insufficiency with FSH > 25 miu.
- Previous ovarian surgery or Chemotherapy.
- On going Anticoagulant use.
- Carcinomas or a history of chronic pelvic pain.
- Present infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PRP effect on ovary for better fertility outcome
Time frame: one year
This is a prospective cohort clinical observational study. Aiming at evaluating the clinical effects of injecting PRP(Platelet Rich Plasma) into ovaries, of poor responders, taking all measures which may improve the response rate. That is why we will inject PRP for 2 consecutive cycles, the first cycle via laparoscopy and the next cycle, via ultrasonography.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
Related trials for Poor Responders
RecruitingObservational study
Proteomic and Biological Characterisation of Plasma for the Study of Changes Following Ovarian Reactivation Treatment
Poor Ovarian Response, Ovarian Reactivation
Not yet recruitingPhase 2
Immunotherapy With Glatiramer Acetate in PLWHIV in Poor Immunological Responders on Antiretroviral Therapy
HIV - Human Immunodeficiency Virus
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation for Poor Weight-Loss Response to Incretin Receptor Agonists
Obesity & Overweight
Not yet recruitingPhase 1/2
Drospirenone-Primed Ovarian Stimulation Versus GnRH Antagonist Protocol in Poor Ovarian Responders Undergoing Freeze-All IVF/ICSI
Poor Ovarian Reserve, Infertility (IVF Patients)
RecruitingPhase 2/3
Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders
Poor Response to Ovulation Induction, Infertility, Female
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Poor Responders, run by Bassem Ayman Mahmoud Assaf 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 5 inclusion and 7 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 29 Oct 2024. 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?
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?
PRP effect on ovary for better fertility outcome (time frame: one year). 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 29 Oct 2024.