Infertility, FemaleNCT03946813
The Efficacy of Platelets Rich Plasma for Ovarian Rejuvenation
A study testing Autologous PRP preparation in people with Infertility, Female, run by Al-Kindy College of Medicine at 1 site in Iraq.
Trial summary
In recent years, an increased approach has appeared in the use of autologous blood products to assist tissue and organ healing. Application of platelet rich plasma (PRP) has emerged as a potential solution for infertile women with poor ovarian reserve in reproductive specialty. Read more about this study
- Who is it for?
- Ages 20 to 49 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Autologous PRP preparation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIraq
- Study dates
- 20 Aug 2018to 31 May 2019
- 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 20 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Menopause or peri-menopause under the age of 50.
- Premature ovarian insufficiency which is ovarian failure before the age of 40.
- Woman with primary ovarian failure of any cause.
Who cannot join
- A previous injection with any medication, plasma, or PRP
- Invisible or difficult access ovaries.
- Medical disease or unfit for anesthesia patient.
Trial locations and contacts
1 site in 1 country.
Iraq1 site
High Institute for Infertility Diagnosis and Assisted Reproductive Technologies
Baghdad
About this study
Official title: The Efficacy of Platelets Rich Plasma (PRP) for Ovarian Rejuvenation
In recent years, an increased approach has appeared in the use of autologous blood products to assist tissue and organ healing. Application of platelet rich plasma (PRP) has emerged as a potential solution for infertile women with poor ovarian reserve in reproductive specialty.
Read the detailed description
Quantitative and qualitative functional improvement of ovarian function has been reported in several studies after using autologous PRP in a reproductive field. Ovarian rejuvenation, stimulating the ovaries to produce new eggs after injecting PRP, can offer hope for renewed fertility to women with poor reserve volume, advanced maternal age, or either naturally occurring or premature menopause. But, these encouraging results should be supported by several new studies.
This study aimed to estimate the efficacy of trans-vaginal ovarian injection with PRP in rejuvenates ovaries in woman with poor ovarian reserve, and to assess any association of some women variables (age, menstrual status, parity, BMI) as predicting factors in success of ovarian injection with PRP.
- Conditions
- Infertility, Female
- Being tested
- Autologous PRP preparation
- Keywords
- Ovarian Rejuvenation , Infertility
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous PRP preparationOther
Also called Plasma Rich Platelets
For each patient, autologous PRP preparation havs to be injected to both ovaries and ultrasound (US) guide
| Study group | Role | What they receive |
|---|---|---|
| Poor ovarian reserve | Experimental | Infertile women with poor ovarian reserve Receives: Other: Autologous PRP preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follicle-stimulating hormone (FSH) concentration
Before after intervention measurement
Measured: 4 weeks
Anti-Müllerian hormone (AMH) concentration
Before after intervention measurement
Measured: 4 weeks
Antral follicles numbers
Before after intervention measurement
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start20 Aug 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Kindy College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- High Institute for Infertility Diagnosis and Assisted Reproductive Technologies
- Responsible party
- Principal investigator, Yousif Abdulraheem, Al-Kindy College of Medicine
- Investigators
- Thuraya H Abdulla, Professor, Study director, Arab Board for Medical Specializations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946813
- Sponsor's protocol ID
- 12 Al-KindyCM
- Status last verified
- Oct 2019
- First submitted
- 6 May 2019
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be managed confidentially
Publications
A
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Platelets Rich Plasma (PRP) for Ovarian Rejuvenation
- ClinicalTrials.gov ID
- NCT03946813
- Acronym / sponsor ID
- 12 Al-KindyCM
- Conditions
- Infertility, Female
- Keywords
- Ovarian Rejuvenation , Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Al-Kindy College of MedicineUniversity, hospital or other
- Collaborators
- High Institute for Infertility Diagnosis and Assisted Reproductive Technologies
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 13 May 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.
In recent years, an increased approach has appeared in the use of autologous blood products to assist tissue and organ healing. Application of platelet rich plasma (PRP) has emerged as a potential solution for infertile women with poor ovarian reserve in reproductive specialty.
Detailed description
Quantitative and qualitative functional improvement of ovarian function has been reported in several studies after using autologous PRP in a reproductive field. Ovarian rejuvenation, stimulating the ovaries to produce new eggs after injecting PRP, can offer hope for renewed fertility to women with poor reserve volume, advanced maternal age, or either naturally occurring or premature menopause. But, these encouraging results should be supported by several new studies.
This study aimed to estimate the efficacy of trans-vaginal ovarian injection with PRP in rejuvenates ovaries in woman with poor ovarian reserve, and to assess any association of some women variables (age, menstrual status, parity, BMI) as predicting factors in success of ovarian injection with PRP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Poor ovarian reserve | Experimental | Other: Autologous PRP preparationInfertile women with poor ovarian reserve |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Menopause or peri-menopause under the age of 50.
- Premature ovarian insufficiency which is ovarian failure before the age of 40.
- Woman with primary ovarian failure of any cause.
Key exclusion criteria (3 listed)
- A previous injection with any medication, plasma, or PRP
- Invisible or difficult access ovaries.
- Medical disease or unfit for anesthesia patient.
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 |
|---|---|---|
| Autologous PRP preparationAlso: Plasma Rich PlateletsFor each patient, autologous PRP preparation havs to be injected to both ovaries and ultrasound (US) guide | Other | Poor ovarian reserve |
Primary outcome
Follicle-stimulating hormone (FSH) concentration
Time frame: 4 weeks
Before after intervention measurement
Anti-Müllerian hormone (AMH) concentration
Time frame: 4 weeks
Before after intervention measurement
Antral follicles numbers
Time frame: 4 weeks
Before after intervention measurement
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 6 May 2023.
- Results publicationA
- Individual participant dataSharing planned: No. All data will be managed confidentially
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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.
Thuraya H Abdulla, Professor study director
Arab Board for Medical Specializations
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous PRP preparation in people with Infertility, Female, run by Al-Kindy College of Medicine at 1 site in Iraq.
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 3 inclusion and 3 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 6 May 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 Iraq. 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?
Follicle-stimulating hormone (FSH) concentration (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03946813, which also lists 1 linked publication.
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 6 May 2023.