Clinical trial NCT03916978: Autologous PRP Intra Ovarian Infusion to Restore Ovarian Function in Menopausal Women
Official title: Investigating Reactivation of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Menopausal Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Infertility, Female
Anovulatory Infertility
Menopause
Amenorrhea
Keywords: Ovarian rejuvenation
Ovarian reactivation; ovulation
Lead sponsor: Genesis Athens Clinic
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
First posted: 2019-04-16
Enrollment: 100
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Restoration of menstrual cycle
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 estradiol 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 progesterone 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: Centre of Human Reproduction, Genesis Athens Clinic
name: Agni Pantou, MD
role: PRINCIPAL_INVESTIGATOR
References: