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9 Primary Ovarian Insufficiency Trials
Power is an online platform that helps thousands of Primary Ovarian Insufficiency patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Ovarian Tissue Transplantation for Premature Ovarian Failure
Cleveland, OhioPremature ovarian failure, also known as primary ovarian insufficiency (POI), or premature menopause, affects 1-2% of women under 40. The diagnosis is typically made based on high levels of follicle stimulating hormone (FSH) and absent or irregular menstrual periods. It leads to infertility and menopause-like effects (hot flashes and thin bones) due to low estrogen levels. POI can result from various factors such as genetic conditions, autoimmune diseases, or previous medical treatments like chemotherapy.
Treatment of POI usually involves hormone replacement therapy and, if pregnancy is desired, assisted reproductive technologies such as in vitro fertilization (IVF) using an egg donor. However, IVF may not be an option for everyone due to personal, religious, ethical or financial reasons. Recent advances in medicine have identified ovarian tissue transplantation (OTT) as a potential solution. OTT involves transplanting either fresh or frozen ovarian tissue into the pelvic area, where it can begin functioning again. Studies in animals and humans have shown success in restoring hormonal function and even achieving pregnancies in some cases. Initial human trials of ovarian tissue transplants from another individual began with identical twins and have since expanded to include non-identical siblings with compatible tissue matches using immunosuppression. Success rates of OTT have been promising, with multiple live births reported between identical twins. Long-term studies indicate that transplanted tissue can remain functional for up to eight years. Ovarian tissue transplantation offers a promising avenue for women with POI to help restore fertility and hormonal function. Continued research and refinement of tissue techniques are essential to improve outcomes and expand access to this innovative treatment option.
This study will enroll 10 participants who will undergo ovarian tissue transplantation donated by a non-identical sister using an immunosuppression protocol at University Hospitals.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:21 - 40
Sex:Female
10 Participants Needed
Veliparib + Chemotherapy for Advanced Cancer
Cleveland, OhioThis phase I trial studies the side effects and the best dose of veliparib when given together with paclitaxel and carboplatin in treating patients with solid tumors that are metastatic or cannot be removed by surgery and liver or kidney dysfunction. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving veliparib together with paclitaxel and carboplatin may kill more tumor cells.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:18+
Sex:All
94 Participants Needed
Autologous Ovarian Tissue Transplant for Infertility
Pittsburgh, PennsylvaniaChemotherapy and radiation for cancer and other conditions can cause infertility. Several centers around the world are cryopreserving ovarian tissue from these patients though an experimental protocol, including the Fertility Preservation Program in Pittsburgh (protocol PRO08050491). The objective of this study is to study the efficacy and safety of autologous tissue transplantation in patients diagnosed with primary ovarian insufficiency after chemotherapy and/or radiation treatments.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:High Surgical Risk, BRCA Mutations, Leukemia, Ovarian Cancer, Others
5 Participants Needed
Hormone Replacement Therapy for Premature Ovarian Failure
Bethesda, MarylandBackground:
Premature ovarian insufficiency (POI) is a condition in which women under the age of 40 years have absent or irregular menstrual cycles. POI can cause infertility, signs of menopause, osteoporosis, and other symptoms. Hormone replacement therapy (HRT) is a treatment that gives women extra hormones, such as estrogen and progesterone. HRT works well in adult women. Researchers want to find the most effective doses and regimens for adolescents.
Objective:
To monitor the effects of HRT on adolescents with POI.
Eligibility:
Female adolescents aged 11 to 19 years diagnosed with POI. Healthy volunteers are also needed.
Design:
All participants will have clinic visits every 6 months for 2 years. Each visit may last 2 days. Each visit may include:
Blood and urine tests.
A test of their heart function.
A test to measure the stiffness of their blood vessels. Participants will lie flat with a blood pressure cuff on a leg and a meter on the neck while the cuff inflates.
A test of their grip strength. Participants will squeeze a handheld device as hard as they can.
Two scans to measure bone density. For one, participants will lie on a table while a scanner passes along their body. For the other, participants will sit in a chair and insert their forearm, then their lower leg, into a scanner.
A test to measure skin pigmentation. Participants skin will be touched lightly with a device.
An optional visual exam of the vagina. Some vaginal fluid may also be collected with a cotton swab/cytobrush.
Participants with POI will receive HRT. They will be given estrogen patches and progesterone pills.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Early Phase 1
Age:11 - 19
Sex:Female
185 Participants Needed
Ovarian Tissue Cryopreservation for Premature Ovarian Failure
New York, New YorkThe study hopes to contribute to the development of technologies of ovarian tissue freezing-thawing and in vitro maturation of immature eggs such that a person at risk for premature ovarian failure might be able to conceive a genetically related child.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:< 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Menopause, No Surgery Clearance, Others
300 Participants Needed
PET Scans for Heart Disease Risk Assessment in Women
Ottawa, OntarioThe full HER CROWN will be a prospective cohort study to propose a novel, women-specific cardiovascular risk score/ algorithm in the prediction of hard cardiovascular outcomes (myocardial infarction, unstable angina, coronary revascularization, stroke, total and cardiovascular mortality). This future study will be the first longitudinal cohort study, to our knowledge, that is focused entirely on researching the pathophysiology and natural history of cardiovascular disease in women with known female-specific risk factors. Further, the investigators are aiming to recruit a sample that is representative of the ethnic distribution in Canada. The proposed pilot study is a feasibility study as an essential preparatory step for HER CROWN.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:25 - 55
Sex:Female
Key Eligibility Criteria
Disqualifiers:Male, Pregnant, CVD, Neurodegenerative, Others
210 Participants Needed
Micronized Progesterone for Turner Syndrome
Kansas City, MissouriThis is a single-site open label non-randomized study comparing effects of sequential versus continuous use of progesterone supplementation amongst Turner Syndrome (TS) patients with primary ovarian insufficiency (POI) prescribed hormone replacement therapy (HRT).
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 4
Age:12 - 20
Sex:Female
40 Participants Needed
Mind-Body Intervention for Sexual Dysfunction in Breast Cancer Survivors
Little Rock, ArkansasThe goal of this clinical trial is to test the efficacy of a nurse-led psychoeducational sexual health intervention for young women breast cancer survivors. The main questions it aims to answer are:
1. What is the feasibility of this intervention in an online, private setting?
2. What is the effect of this intervention on reducing menopausal symptoms, improving sexual functioning, and enhancing body image?
Participants will participate in a nurse-led psychoeducational intervention for 8 sessions lasting approximately an hour each over the course of 16 weeks. Each participant will complete survey items at the beginning, end, and six-weeks after the last session. Participants will be compensated up to $150 in gift cards as a thank-you for their time.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 50
Sex:Female
43 Participants Needed
Strength Training for Osteoporosis
Calgary, AlbertaThe goal of this clinical pilot trial is to learn about the feasibility of a high-intensity resistance training intervention in peri- and early menopausal females. The main question it aims to answer are:
-Is a 9-month resistance training intervention feasible (e.g., recruitment rates, protocol adherence, attrition)
Secondary aims include examining changes in bone health, muscle strength, and menopausal symptoms.
Participants will participate in a 9-month progressive, supervised, resistance training intervention. Researchers will compare secondary outcomes between the exercise group and a wait-list control group.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:45 - 60
Sex:Female
40 Participants Needed
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Frequently Asked Questions
How much do Primary Ovarian Insufficiency clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Primary Ovarian Insufficiency clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Primary Ovarian Insufficiency trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Primary Ovarian Insufficiency is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Primary Ovarian Insufficiency medical study ?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Primary Ovarian Insufficiency clinical trials ?
Most recently, we added Ovarian Tissue Transplantation for Premature Ovarian Failure, Micronized Progesterone for Turner Syndrome and Hormone Replacement Therapy for Premature Ovarian Failure to the Power online platform.