Improving ovarian function with platelet-rich plasma injections
Randomized Controlled Trial of Ovarian Function Following Intraovarian Injection of Platelet Rich Plasma for Women With Ovarian Aging
NA · Center for Human Reproduction · NCT04278313
This study is testing if injections of platelet-rich plasma can help women with reduced ovarian function, especially those facing early menopause, by promoting the growth of their eggs.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 21 Years to 44 Years |
| Sex | Female |
| Sponsor | Center for Human Reproduction (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04278313 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of intraovarian injections of platelet-rich plasma (PRP) on women with diminished ovarian reserve, particularly those experiencing premature ovarian aging. Participants will be randomly assigned to receive either PRP or platelet-poor plasma (PPP) in a double-blind manner. The study aims to assess whether the growth factors in PRP can enhance ovarian function and promote the growth of antral follicles. A total of 90 women aged 44 and under with specific hormonal profiles and previous low oocyte retrieval will be recruited for this trial.
Who should consider this trial
Good fit: Ideal candidates are women aged 44 and under with fewer than 6 oocytes retrieved in previous ovulation attempts and specific hormonal levels indicating diminished ovarian reserve.
Not a fit: Patients over the age of 45 or those with significant blood disorders or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve ovarian function and fertility outcomes for women with diminished ovarian reserve.
How similar studies have performed: While the use of PRP in reproductive medicine is emerging, this specific approach has not been extensively tested in prior studies, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * fewer than 6 oocytes in response to past ovulation induction * desire to establish a pregnancy using IVF * Age 44 years and under. * FSH \> 12 * AMH \< 1.0 * No Aspirin or Motrin for one week before treatment Exclusion Criteria: * Age \> 45 years * Marked thrombocytopenia * Blood diseases * Hypofibrinogenemia * Hemodynamic instability * Anticoagulant or antiaggregant treatment * Oncological diseases (specially, skeletal system and blood) * Sepsis * Acute and chronic infectious diseases * Autoimmune diseases, for example, lupus erythematosus, etc.
Where this trial is running
New York, New York
- Center for Human Reproduction — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: David H Barad, MD — Center for Human Reproduction
- Study coordinator: David Barad, MD
- Email: dbarad@theCHR.com
- Phone: 2018417587
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diminished Ovarian Reserve, Diminished Ovarian Reserve Due to Advanced Maternal Age, Infertility - Ovarian dysfunuction, Premature Ovarian Aging