Clinical trial NCT03951194: Autologous Platelet Rich Plasma (PRP) Intra Ovarian Infusion in Perimenopausal Women
Official title: Investigating Improvement of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Perimenopausal Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Infertility, Female
Perimenopausal Disorder
Menstrual Cycle Abnormal
Lead sponsor: Genesis Athens Clinic
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
First posted: 2019-05-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Restoration of menstrual cycle regularity
timeFrame: Three months
measure: Serum FSH levels
timeFrame: Follow-up period of three months entailing monthly evaluation
Secondary outcomes:
measure: Serum AMH levels
timeFrame: Follow-up period of three months entailing monthly evaluation
measure: Serum LH levels
timeFrame: Follow-up period of three months entailing monthly evaluation
measure: Serum Estradiol levels
timeFrame: Follow-up period of three months entailing monthly evaluation
measure: Serum Progesteron levels
timeFrame: Follow-up period of three months entailing monthly evaluation
measure: Antral Follicle Count
timeFrame: Follow-up period of three months entailing monthly evaluation
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Genesis AC
Study officials:
affiliation: Obstetrician Gynecologist
name: Agni Pantou, MD
role: STUDY_DIRECTOR
References: