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New treatment option for Menopause, Premature
Official title Autologous PRP Infusion May Restore Ovarian Function and May Promote Folliculogenesis in POI Patients
ClinicalTrials.gov ID: NCT04031456
What this study is testing
What is Autologous Platelet Rich Plasma?
Autologous Platelet Rich Plasma is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for menopause, premature.
Also referred to as PRP, Platelet Rich Plasma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve patients' hormonal profile in patients presenting with POI.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 39, women only. Healthy volunteers may be eligible.
You may be able to join if
- Age \ 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...
- Willing to comply with study requirements
You likely can't join if
- Any pathological disorder related to reproductive system anatomy
- AMH \> 8 pmol/L
- Endometriosis
- Adenomyosis
- Fibroids and adhesions
- Infections in reproductive system
See the full eligibility criteria
- Age \ 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Athens, Greece
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 25 years to 39 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Athens, Greece. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.