Autologous Platelet Rich Plasma (PRP) Intra Ovarian Infusion in Perimenopausal Women (NCT03951194) | Clinical Trial Compass
UnknownPhase 2/3
Autologous Platelet Rich Plasma (PRP) Intra Ovarian Infusion in Perimenopausal Women
Greece100 participantsStarted 2019-06-13
Plain-language summary
Autologous PRP intra ovarian infusion may improve ovarian response and women's hormonal profile and may promote folliculogenesis in perimenopausal women.
Who can participate
Age range40 Years – 50 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:
* 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
What they're measuring
1
Restoration of menstrual cycle regularity
Timeframe: Three months
2
Serum FSH levels
Timeframe: Follow-up period of three months entailing monthly evaluation