Amenorrhea, Anovulatory Infertility, Infertility, Female, Menopause
Conditions
Keywords
Ovarian rejuvenation, Ovarian reactivation; ovulation
Brief summary
Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve hormonal profile of women in menopause.
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 menopausal 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 restoring ovarian tissue functionality in menopausal women.
Interventions
BIOLOGICALAutologous PRP intra ovarian infusion
Autologous PRP intra ovarian infusion
BIOLOGICALAutologous 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
45 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 45-55 years old * Amenorrhea for at least 12 months * 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 * Previous POI diagnosis * Abnormal karyotype * Endometriosis * Adenomyosis * Fibroids and adhesions * Infections in reproductive system * Current or previous diagnosis of reproductive system cancer * 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 | Menstrual cycle restoration |
| 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 estradiol levels | Follow-up period of three months entailing monthly evaluation | Serum estradiol 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 progesterone 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
PRINCIPAL_INVESTIGATORAgni Pantou, MD
Centre of Human Reproduction, Genesis Athens Clinic
Outcome results
None listed