Premature Ovarian FailureNCT04149028
Platelet Rich Plasma Injection Into Ovary of Patients With Premature Ovarian Insufficiency
A study testing PRP injection inside the ovary by laparoscoy. The injection volume is 2 ml in people with Premature Ovarian Failure, run by Tanta University at 1 site in Egypt.
Trial summary
All encountered cases with POI will be assessed and examined then investigated. Eligible cases will be included in the study Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Premature Ovarian Failure
- What is being tested?
- PRP injection inside the ovary by laparoscoy. The injection volume is 2 ml
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2019to 31 Dec 2022
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premature ovarian insufficiency diagnosed by:
- FSH> 40 Amenorrhea Menopuasal symptoms Infertility
Who cannot join
- Refusal to participate Secondary POI due chemotherapy, surgery, or radiotherapy Previous treatment with PRP
Trial locations and contacts
1 site in 1 country.
About this study
All encountered cases with POI will be assessed and examined then investigated. Eligible cases will be included in the study
Read the detailed description
Patients will be subjected to injection of autologous PRP inside the ovary about 0.5-1 mml by laparoscopy
- Conditions
- Premature Ovarian Failure
- Being tested
- PRP injection inside the ovary by laparoscoy. The injection volume is 2 ml
- Keywords
- Premature ovarian insuffiency, Infertility, PRP
- Medical subject headings
- Primary Ovarian Insufficiency, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP injection inside the ovary by laparoscoy. The injection volume is 2 mlProcedure or surgery
intraovarian injection of 2 mml of PRP by laparoscopic guide
| Study group | Role | What they receive |
|---|---|---|
| PRP injection | Experimental | injection of PRP inside ovary by the assistance of laparoscopy Receives: Procedure: PRP injection inside the ovary by laparoscoy. The injection volume is 2 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resumption of ovarian hormonal function
Measurement of Estradiol level on Day 3 of cycle
Measured: 3-6 months
Resumption of ovarian folliclugenesis
Assessment of the presence of oocytes by trans vaginal ultrasound on day 3
Measured: 3-6 months
Secondary outcomes (2)
Resumption of menstruation
Occurrence of Menstruation after secondary amenrorrhea by questionnaire
Measured: 3-6 months
Fertility potential
Potential to get pregnant after ICSI procedure
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start1 Dec 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian FailureStudies of the same condition, open and under way.
- More trials run by Tanta 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All eligible patient will recieve the treatment with PRP
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman S Dawood, MD, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149028
- Sponsor's protocol ID
- POFPRP
- Status last verified
- Feb 2023
- First submitted
- 30 Oct 2019
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: we will decide later
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Rich Plasma Injection Into Ovary of Patients With Premature Ovarian Insufficiency
- ClinicalTrials.gov ID
- NCT04149028
- Acronym / sponsor ID
- POFPRP
- Conditions
- Premature Ovarian Failure
- Keywords
- Premature ovarian insuffiency, Infertility, PRP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 4 Nov 2019 (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.
All encountered cases with POI will be assessed and examined then investigated. Eligible cases will be included in the study
Detailed description
Patients will be subjected to injection of autologous PRP inside the ovary about 0.5-1 mml by laparoscopy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All eligible patient will recieve the treatment with PRP
| Arm | Type | Receives |
|---|---|---|
| PRP injection | Experimental | Procedure: PRP injection inside the ovary by laparoscoy. The injection volume is 2 mlinjection of PRP inside ovary by the assistance of laparoscopy |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Premature ovarian insufficiency diagnosed by:
- FSH> 40 Amenorrhea Menopuasal symptoms Infertility
Key exclusion criteria (1 listed)
- Refusal to participate Secondary POI due chemotherapy, surgery, or radiotherapy Previous treatment with PRP
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 |
|---|---|---|
| PRP injection inside the ovary by laparoscoy. The injection volume is 2 mlintraovarian injection of 2 mml of PRP by laparoscopic guide | Procedure or surgery | PRP injection |
Primary outcome
Resumption of ovarian hormonal function
Time frame: 3-6 months
Measurement of Estradiol level on Day 3 of cycle
Resumption of ovarian folliclugenesis
Time frame: 3-6 months
Assessment of the presence of oocytes by trans vaginal ultrasound on day 3
2 secondary outcomes
Resumption of menstruation
Time frame: 3-6 months
Fertility potential
Time frame: 3-6 months
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 17 Feb 2023.
- Individual participant dataSharing planned: Undecided. we will decide later
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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.
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?
A study testing PRP injection inside the ovary by laparoscoy. The injection volume is 2 ml in people with Premature Ovarian Failure, run by Tanta 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: finished, as of the sponsor's last update on 17 Feb 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.
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?
Resumption of ovarian hormonal function (time frame: 3-6 months). The study lists 2 primary outcomes in all. 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 17 Feb 2023.