What side effects are associated with this type of intervention?

Common treatments for menopause, such as Menopausal Hormone Therapy (MHT) which includes estrogen and progestin, can have several side effects. These may include an increased risk of blood clots, stroke, and breast cancer, particularly with long-term use. Transdermal progesterone, which is considered an alternative, is generally well-tolerated but can cause skin irritation at the application site. While Platelet-Rich Plasma (PRP) injections are being studied for various conditions, specific side effects related to its use in menopause are not well-documented in the provided context.

What prior FDA approvals exist?

FDA-approved treatments for menopause primarily include hormone therapies such as 17-beta estradiol and conjugated equine estrogens (CEE), which are used to manage symptoms like hot flashes. Progestins, such as micronized progesterone, are also approved for use in combination with estrogen in women with an intact uterus. These treatments help alleviate menopausal symptoms but are not related to the regenerative properties of platelet-rich plasma (PRP), which is still under investigation for other potential uses.

What other types of research exist?

Promising novel alternatives to Autologous PRP injections for menopause patients include stem cell therapy and low-intensity shock therapy (LIST). Stem cell therapy involves the use of adipose-derived stem cells to promote tissue regeneration, while LIST uses low-intensity shocks to stimulate neovascularization and improve tissue healing. Both therapies are still investigational but show potential for future use.

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Other

A-PRP for Primary Ovarian Insufficiency (PRP4POI Trial)

N/A

Waitlist Available

Led By Norbert Gleicher, MD

Research Sponsored by Center for Human Reproduction

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Summary

This trial involves injecting a patient's own concentrated blood plasma into one ovary to help repair and improve its function. It targets women with Premature Ovarian Insufficiency, a condition causing early loss of ovarian function. The treatment aims to use growth factors from platelets to rejuvenate the ovary. Concentrated blood plasma has been used in various medical fields for its regenerative properties, and recent studies have shown promising results in ovarian rejuvenation and improving ovarian function in women with conditions like Premature Ovarian Insufficiency.

Who is the study for?

This trial is for women under 40 with primary ovarian insufficiency (early menopause) who have no detectable AMH levels, high FSH levels, and are willing to undergo IVF if needed. Participants must not take NSAIDs like Aspirin a week before treatment, have two ovaries of similar size without large follicles, and provide informed consent.

What is being tested?

The study tests the effects of injecting autologous PRP (a substance made from the patient's own blood that may help tissue repair) into one ovary of women with premature menopause to see if it can restore ovarian function.

What are the potential side effects?

While specific side effects of A-PRP injections aren't detailed here, common ones could include pain at the injection site, infection risk, bleeding or bruising. Since it uses the patient's own blood components, risks are generally considered low.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ovarian Follicles

Secondary study objectives

Clinical Pregnancy

Increase in serum AMH

Retrieval of oocytes in an IVF cycle

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: A-PRPExperimental Treatment1 Intervention

The cortex of selected ovary will be injected with autologous platelet rich plasma.

Group II: ControlActive Control1 Intervention

The contralateral ovary will not be injected.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

A-PRP

2018

N/A

~40

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Menopausal hormone therapy (MHT) primarily involves the administration of estrogen, with or without progestin, to alleviate symptoms such as hot flashes, night sweats, and vaginal dryness. Estrogen helps to stabilize the thermoregulatory center in the brain, reducing the frequency and severity of hot flashes. Progestins are added for women with an intact uterus to prevent endometrial hyperplasia, which can be caused by unopposed estrogen. The relevance of these treatments lies in their ability to significantly improve the quality of life for menopausal women by addressing disruptive symptoms. Additionally, Platelet-Rich Plasma (PRP) injections, which promote tissue regeneration and healing through growth factors, are being explored for their potential benefits in treating menopausal symptoms, although more research is needed to establish their efficacy and safety in this context.

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Who is running the clinical trial?

Center for Human ReproductionLead Sponsor

13 Previous Clinical Trials

1,133 Total Patients Enrolled

2 Trials studying Primary Ovarian Insufficiency

215 Patients Enrolled for Primary Ovarian Insufficiency

Norbert Gleicher, MDPrincipal InvestigatorMedical Director

8 Previous Clinical Trials

791 Total Patients Enrolled

3 Trials studying Primary Ovarian Insufficiency

220 Patients Enrolled for Primary Ovarian Insufficiency

Media Library

A-PRP (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03542708 — N/A

Primary Ovarian Insufficiency Research Study Groups: Control, A-PRP

Primary Ovarian Insufficiency Clinical Trial 2023: A-PRP Highlights & Side Effects. Trial Name: NCT03542708 — N/A

A-PRP (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03542708 — N/A

Primary Ovarian Insufficiency Patient Testimony for trial: Trial Name: NCT03542708 — N/A

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