Menopause, Premature, Menopause Related Conditions, Menopausal Syndrome, Premature Ovarian Failure, Ovarian Failure, Premature
Conditions
Brief summary
Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve patients' hormonal profile in patients presenting with POI.
Detailed description
This triple-blind Randomized Controlled Trial (RCT) aims to investigate the effectiveness of autologous PRP intra ovarian infusion on reactivating ovarian functionality and on promoting folliculogenesis in regard to patients presenting with POI. PRP is blood plasma prepared from fresh whole blood that has been enriched with platelets. It is collected from peripheral veins and contains several growth factors such as vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), platelet derived growth factor (PDGF), transforming growth factor (TGF) and other cytokines all of which stimulate tissue proliferation and growth. PRP has been employed in several medical conditions in Orthopedics, Dermatology, and Ophthalmology for wound healing. It's efficacy in ovarian rejuvenation and reactivation and endometrial regeneration has not been fully elucidated. This study aims to investigate the effect of autologous PRP intra ovarian infusion on restoring ovarian tissue functionality in POI patients.
Interventions
BIOLOGICALAutologous Platelet Rich Plasma
Autologous PRP intra ovarian infusion
BIOLOGICALPlacebo-Platelet Free Plasma
Autologous PFP intra ovarian infusion
Sponsors
National and Kapodistrian University of Athens
Genesis Athens Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
* Age \< 40 years, presenting with amenorrhea or menstrual cycle irregularities for at least four months, and elevated FSH levels \>25 IU/L recorded on two occasions \>4 weeks apart * Normal Karyotype: 46, XX * Discontinuation of any complementary/adjuvant treatment including hormone replacement, acupuncture, and botanotherapy, for at least three months prior to recruitment. * Willing to comply with study requirements
Exclusion criteria
* Any pathological disorder related to reproductive system anatomy * AMH \> 8 pmol/L * Endometriosis * Adenomyosis * Fibroids and adhesions * Infections in reproductive system * Current or previous diagnosis of cancer in reproductive system * History of familiar cancer in reproductive system * Severe male factor infertility * Prior referral for PGT * Ovarian inaccessibility * Endocrinological disorders (Hypothalamus-Pituitary disorders, thyroid dysfunction, diabetes mellitus, metabolic syndrome) * BMI\>30 kg/m2 or BMI\<18.5 kg/m2 * Systematic autoimmune disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Restoration of menstrual cycle | Three months | Regular menstrual cycle |
| Serum FSH levels | Follow-up period of three months entailing monthly evaluation | Serum FSH levels evaluated monthly for three consecutive months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Estradiol levels | Follow-up period of three months entailing monthly evaluation | Serum estradiol levels evaluated monthly for three consecutive months |
| Serum AMH levels | Follow-up period of three months entailing monthly evaluation | Serum ΑΜΗ levels evaluated monthly for three consecutive months |
| Antral Follicle Count (AFC) | Follow-up period of three months entailing monthly evaluation | AFC evaluated monthly, on day 2 of the menstrual cycle, for three consecutive months |
| Serum Progesteron levels | Follow-up period of three months entailing monthly evaluation | Serum progesterone levels evaluated monthly for three consecutive months |
| Serum LH levels | Follow-up period of three months entailing monthly evaluation | Serum LH levels evaluated monthly for three consecutive months |
Countries
Greece
Contacts
Primary ContactMara Simopoulou, PhD
Backup ContactAgni Pantou, MD, PhD Candidate
Outcome results
None listed