IVFPhase 3NCT06048666
Platelet Rich Plasma on Ovarian Reserve Parameters and Intra Cytoplasmic Sperm Injection Outcomes in Patients With Diminished Ovarian Reserve
A Phase 3 study testing Intra ovarian by platelet rich plasma in people with IVF, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the efficacy of intra ovarian injection of autologous platelet rich plasma on ovarian reserve parameters and ICSI outcomes in poor ovarian reserve. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- IVF
- What is being tested?
- Intra ovarian by platelet rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2023to 30 Sep 2024
- Phase
- Phase 3
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women under the age of 40.
- have been infertile for more than a year
- have had at least one previous unsuccessful (or cancelled) IVF cycle.
- having one of the criteria of poor ovarian response including anti mullerian hormone (AMH) level <1.1 ng /ml ,the antral follicle count of two ovaries in vaginal ultrasound <7 .
Who cannot join
- pregnancy(ruled out and documented before PRP injection) . Hydrosalpinex,uterine malformations and abnormal uterine cavity.
- Partner with severe male factor
- Ongoing malignancy.
- Chronic pelvic pain
- A history of major lower abdomen surgeries that resulted in pelvic adhesions.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Beni-suef university Hospital
Banī Suwayf, Beni Suweif Governorate, 62521
About this study
Official title: Effect of Intra-ovarian Injection of Autologous Platelet Rich Plasma on Ovarian Reserve Parameters and Intra Cytoplasmic Sperm Injection Outcomes in Patients With Diminished Ovarian Reserve
The aim of this study is to evaluate the efficacy of intra ovarian injection of autologous platelet rich plasma on ovarian reserve parameters and ICSI outcomes in poor ovarian reserve.
Read the detailed description
fifty_six infertile women suffering from poor ovarian reserve \&following up at IVF Unit of Beni_suef University hospital. , and they fulfilled inclusion and exclusion criteria. they will be classlfied into two groups: Group A (study group) (involve 28 patient ):will be injected intra ovarian by platelet rich plasma Group B (control group) (involve 28 patient): will not be injected intra ovarian by platelet rich Plasma
The researcher will introduce himself to all participants included in this study and requested that they participate after explaining the purpose of the study. All participants will be given detailed information about the study's goal and predicted advantages. All participants will give their informed verbal agreement, and the data will be kept confidential. All patients will be subjected to:
Complete history was taken with special emphasis on:
Personal ,past,family\&surgical history. Menstrual historyObstetric history
Clinical examination:
Physical examination included General examination: Weight, Height, BMI, Abdominal examination , Local (Pelvic) examination
Ultrasound examination:
The women will be in lithotomy position with an empty bladder. On day 2 of the menstrual cycle or withdrawal bleed, a sterile vaginal speculum has been introduced, and a TV ultrasonography probe (7.0-MH endo-vaginal probe) has been placed in the vagina roughly 1 cm away from the cervix to evaluate the volume of the ovary and antral follicle counts (AFC).
Investigations:
General (CBC, urinalysis, Random blood sugar) when needed. Specific: Hormonal profile in all patients of the study, the following were obtained prior to the procedure: Anti-Mullerian hormone (AMH). FSH, Estradiol.
- PRP preparation and time of injection On the day of PRP infusion (within 10 days after completion of menstrual bleeding) we will take 20 cc of venous blood from each participant of group A to prepare PRP. The blood will be transferred to a tube containing sodium citrate and centrifuged at 800 RPM for 15 min and 2000 RPM for 5 min in two stages, respectively. Then, by discarding part of the plasma, PRP will be prepared with a final concentration of one million platelets per microliter. The PRP will be injected into the ovary under spinal anesthesia and a transvaginal ultrasound guide.
- Patien assessment and Follow up. patients injected with PRP will be managed expectantly for 6 weeks to allow spontaneous pregnancy, at the beginning of second menstrual cycle AMH, FSH, AFC will be reassessed.
- 3months after the PRP injection, all women considered poor responders (2groups)will undergo assisted reproductive therapy with antagonist protocol followed by a dose of 450 units of FSH (Gonal F, CinnaGen, Iran). Six days after gonadotropin therapy, vaginal ultrasound will be performed to measure follicle diameter. Once the follicular size is 12 mm, the GnRH antagonist (Cetrorelix, Merck-Serono, Germany) will begin, and gonadotropin continued. When at least two dominant follicles reach the diameter of 18 mm on ultrasound, ovulation will be stimulated using 10,000 units of HCG, and oocyte retrieval will be performed under general anesthesia 34 to 36 h after the HCG injection and the two groups will be compared in terms of the outcomes such as duration of stimulation dosage of gonadotrophine serum of estradiol level on the triggering day ,number and quality of oocytes and embryons and clinical pregnancy
- Conditions
- IVF
- Being tested
- Intra ovarian by platelet rich plasma
- Keywords
- platelet rich plasma , poor ovarian reserve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra ovarian by platelet rich plasmaBiological
On the day of PRP infusion (within 10 days after completion of menstrual bleeding) we will take 20 cc of venous blood from each participant of group A to prepare PRP. The blood will be transferred to a tube containing sodium citrate and centrifuged at 800 RPM for 15 min and 2000 RPM for 5 min in two stages, respectively. Then, by discarding part of the plasma, PRP will be prepared with a final concentration of one million platelets per microliter. The PRP will be injected into the ovary under spinal anesthesia and a transvaginal ultrasound guide.
| Study group | Role | What they receive |
|---|---|---|
| Intra ovarian by platelet rich plasma | Experimental | intra-ovarian injection of autologous platelet rich plasma 3 months after the PRP injection,they will undergo assisted reproductive therapy with antagonist protocol followed by a dose of 450 units of FSH (Gonal F) Receives: Biological: Intra ovarian by platelet rich plasma |
| control | No intervention | they will undergo ICSI trial with antagonist protocol followed by a dose of 450 units of FSH (Gonal F) |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of retrieved oocytes
number of oocytes obtained in ovum pick up
Measured: 1 month of induction for ICSI trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start30 Oct 2023 (estimated)
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Abdallah Mohamed Salem, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048666
- Sponsor's protocol ID
- PRP in poor ovarian reserve
- Status last verified
- Sep 2023
- First submitted
- 16 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intra-ovarian Injection of Autologous Platelet Rich Plasma on Ovarian Reserve Parameters and Intra Cytoplasmic Sperm Injection Outcomes in Patients With Diminished Ovarian Reserve
- ClinicalTrials.gov ID
- NCT06048666
- Acronym / sponsor ID
- PRP in poor ovarian reserve
- Conditions
- IVF
- Keywords
- platelet rich plasma , poor ovarian reserve
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 30 Oct 2023 (estimated)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 21 Sep 2023 (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.
The aim of this study is to evaluate the efficacy of intra ovarian injection of autologous platelet rich plasma on ovarian reserve parameters and ICSI outcomes in poor ovarian reserve.
Detailed description
fifty_six infertile women suffering from poor ovarian reserve \&following up at IVF Unit of Beni_suef University hospital. , and they fulfilled inclusion and exclusion criteria. they will be classlfied into two groups: Group A (study group) (involve 28 patient ):will be injected intra ovarian by platelet rich plasma Group B (control group) (involve 28 patient): will not be injected intra ovarian by platelet rich Plasma
The researcher will introduce himself to all participants included in this study and requested that they participate after explaining the purpose of the study. All participants will be given detailed information about the study's goal and predicted advantages. All participants will give their informed verbal agreement, and the data will be kept confidential. All patients will be subjected to:
Complete history was taken with special emphasis on:
Personal ,past,family\&surgical history. Menstrual historyObstetric history
Clinical examination:
Physical examination included General examination: Weight, Height, BMI, Abdominal examination , Local (Pelvic) examination
Ultrasound examination:
The women will be in lithotomy position with an empty bladder. On day 2 of the menstrual cycle or withdrawal bleed, a sterile vaginal speculum has been introduced, and a TV ultrasonography probe (7.0-MH endo-vaginal probe) has been placed in the vagina roughly 1 cm away from the cervix to evaluate the volume of the ovary and antral follicle counts (AFC).
Investigations:
General (CBC, urinalysis, Random blood sugar) when needed. Specific: Hormonal profile in all patients of the study, the following were obtained prior to the procedure: Anti-Mullerian hormone (AMH). FSH, Estradiol.
- PRP preparation and time of injection On the day of PRP infusion (within 10 days after completion of menstrual bleeding) we will take 20 cc of venous blood from each participant of group A to prepare PRP. The blood will be transferred to a tube containing sodium citrate and centrifuged at 800 RPM for 15 min and 2000 RPM for 5 min in two stages, respectively. Then, by discarding part of the plasma, PRP will be prepared with a final concentration of one million platelets per microliter. The PRP will be injected into the ovary under spinal anesthesia and a transvaginal ultrasound guide.
- Patien assessment and Follow up. patients injected with PRP will be managed expectantly for 6 weeks to allow spontaneous pregnancy, at the beginning of second menstrual cycle AMH, FSH, AFC will be reassessed.
- 3months after the PRP injection, all women considered poor responders (2groups)will undergo assisted reproductive therapy with antagonist protocol followed by a dose of 450 units of FSH (Gonal F, CinnaGen, Iran). Six days after gonadotropin therapy, vaginal ultrasound will be performed to measure follicle diameter. Once the follicular size is 12 mm, the GnRH antagonist (Cetrorelix, Merck-Serono, Germany) will begin, and gonadotropin continued. When at least two dominant follicles reach the diameter of 18 mm on ultrasound, ovulation will be stimulated using 10,000 units of HCG, and oocyte retrieval will be performed under general anesthesia 34 to 36 h after the HCG injection and the two groups will be compared in terms of the outcomes such as duration of stimulation dosage of gonadotrophine serum of estradiol level on the triggering day ,number and quality of oocytes and embryons and clinical pregnancy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra ovarian by platelet rich plasma | Experimental | Biological: Intra ovarian by platelet rich plasmaintra-ovarian injection of autologous platelet rich plasma 3 months after the PRP injection,they will undergo assisted reproductive therapy with antagonist protocol followed by a dose of 450 units of FSH (Gonal F) |
| control | No intervention | –they will undergo ICSI trial with antagonist protocol followed by a dose of 450 units of FSH (Gonal F) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women under the age of 40.
- have been infertile for more than a year
- have had at least one previous unsuccessful (or cancelled) IVF cycle.
- having one of the criteria of poor ovarian response including anti mullerian hormone (AMH) level <1.1 ng /ml ,the antral follicle count of two ovaries in vaginal ultrasound <7 .
Key exclusion criteria (5 listed)
- pregnancy(ruled out and documented before PRP injection) . Hydrosalpinex,uterine malformations and abnormal uterine cavity.
- Partner with severe male factor
- Ongoing malignancy.
- Chronic pelvic pain
- A history of major lower abdomen surgeries that resulted in pelvic adhesions.
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 |
|---|---|---|
| Intra ovarian by platelet rich plasmaOn the day of PRP infusion (within 10 days after completion of menstrual bleeding) we will take 20 cc of venous blood from each participant of group A to prepare PRP. The blood will be transferred to a tube containing sodium citrate and centrifuged at 800 RPM for 15 min and 2000 RPM for 5 min in two stages, respectively. Then, by discarding part of the plasma, PRP will be prepared with a final concentration of one million platelets per microliter. The PRP will be injected into the ovary under spinal anesthesia and a transvaginal ultrasound guide. | Biological | Intra ovarian by platelet rich plasma |
Primary outcome
number of retrieved oocytes
Time frame: 1 month of induction for ICSI trial
number of oocytes obtained in ovum pick up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intra ovarian by platelet rich plasma in people with IVF, run by Beni-Suef 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 4 inclusion and 5 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 Sep 2023. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Beni-suef University (082 2318605 ext. 02, fom@med.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of retrieved oocytes (time frame: 1 month of induction for ICSI trial). 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 Sep 2023.