Clinical trial NCT04031456: Autologous PRP Infusion May Restore Ovarian Function and May Promote Folliculogenesis in POI Patients
Official title: Investigating Reactivation of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in POI Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Menopause, Premature
Menopause Related Conditions
Menopausal Syndrome
Premature Ovarian Failure
Ovarian Failure, Premature
Lead sponsor: Genesis Athens Clinic
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
First posted: 2019-07-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 39
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 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.

Eligibility criteria: 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

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 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 (AFC)
timeFrame: Follow-up period of three months entailing monthly evaluation
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Genesis AC
Study officials:
References: