Autologous PRP Infusion May Restore Ovarian Function and May Promote Folliculogenesis in POI Pati⦠(NCT04031456) | Clinical Trial Compass
RecruitingPhase 2/3
Autologous PRP Infusion May Restore Ovarian Function and May Promote Folliculogenesis in POI Patients
Greece100 participantsStarted 2019-07-30
Plain-language summary
Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve patients' hormonal profile in patients presenting with POI.
Who can participate
Age range25 Years ā 39 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Restoration of menstrual cycle
Timeframe: Three months
2
Serum FSH levels
Timeframe: Follow-up period of three months entailing monthly evaluation