Will Autologous Platelet Rich Plasma Able To Restore Ovarian Function? (NCT04381299) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Will Autologous Platelet Rich Plasma Able To Restore Ovarian Function?
United Arab Emirates35 participantsStarted 2021-04-25
Plain-language summary
A-PRP (Autologous Platelet Rich Plasma) is becoming widely used in a variety of medical procedures seeking tissue remodeling and/or healing as an intervention. To date, applications in orthopedics, wound healing, dermatology and plastic surgery have gained general acceptance, primarily as the role of platelets and their activation in tissue repair and recovery has become better understood at a cellular and molecular level. This study will involve adult women with a diagnosis of Premature ovarian insufficiency (POI) willing to perform an IVF/ICSI treatment.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed and dated informed consent
* Women 40 years of age and younger with documented primary ovarian insufficiency (12).
* Normal Karyotype
* BMI \</= 35 kg/m2
* Oligo/amenorrhea for at least 4 months
* FSH \> 25 IU/mL
* AMH \</= 0,1 ng/ml
* No evidence of follicles \> 4mm
* Must have two ovaries of approximately equal volume.
* Willingness to undergo further fertility treatment, including IVF if there is evidence of response
* A transvaginal scan including Doppler for arteria ovarica will be performed previously to the surgical procedure.
Exclusion Criteria:
* Premature ovarian failure due to a genetic origin, such as Turner's Syndrome or chromosomal abnormality.
* Oncological diseases (specially, skeletal system and blood).
* Autoimmune diseases, for example, lupus erythematosus, etc.
* Previous treatments including radiotherapy or chemotherapy.
* Other conditions not suitable for surgical procedures and/or anesthesia.
* Anticoagulant or antiaggregant treatment.
* Acute and chronic infectious diseases.
* Active substance abuse or dependence.
* Major Mental health disorder.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Appearance of new ovarian follicles (number of follicles growing) with evidence of estradiol production.