Infertility, Female, Menstrual Cycle Abnormal, Perimenopausal Disorder
Conditions
Brief summary
Autologous PRP intra ovarian infusion may improve ovarian response and women's hormonal profile and may promote folliculogenesis in perimenopausal women.
Detailed description
This triple-blind Randomized Controlled Trial (RCT) aims to investigate the effectiveness of autologous PRP intra ovarian infusion on improving ovarian tissue functionality and hormonal profile of perimenopausal women. 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 improving ovarian tissue functionality in perimenopausal women.
Interventions
BIOLOGICALAutologous Platelet Rich Plasma (PRP) intra ovarian infusion
Autologous PRP intra ovarian infusion
OTHERPlacebo: Autologous Platelet Free Plasma (PFP) intra ovarian infusion
Autologous PFP intra ovarian infusion
Sponsors
Genesis Athens Clinic
National and Kapodistrian University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Women ≥40 years of age, presenting with cycle irregularities while fulfilling at least one of the respective two criteria: more than seven days difference in menstrual cycle duration between two consecutive cycles OR, presence of a menstrual cycle duration over sixty days and progressive elevation of FSH levels. * 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 * Amenorrhea * 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 * Previous POI diagnosis -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 regularity | 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 AMH levels | Follow-up period of three months entailing monthly evaluation | Serum AMH 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. |
| Serum Estradiol levels | Follow-up period of three months entailing monthly evaluation | Serum etsradiol levels evaluated monthly 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. |
| Antral Follicle Count | Follow-up period of three months entailing monthly evaluation | AFC evaluated monthly, on day 2 of the menstrual cycle, for three consecutive months. |
Countries
Greece
Contacts
CONTACTMara Simopoulou, PhD
CONTACTAgni Pantou, MD, PhD Candidate
STUDY_DIRECTORAgni Pantou, MD
Obstetrician Gynecologist
Outcome results
None listed