RecruitingPhase 2Phase 3NCT04031456

Autologous PRP Infusion May Restore Ovarian Function and May Promote Folliculogenesis in POI Patients

Investigating Reactivation of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in POI Patients

Sponsor

Genesis Athens Clinic

Enrollment

100 participants

Start Date

Jul 30, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve patients' hormonal profile in patients presenting with POI.

Eligibility

Sex: FEMALEMin Age: 25 YearsMax Age: 39 Years

Inclusion Criteria4

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 Criteria14

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