Blocking RANKL with denosumab to protect ovarian follicles
Clinical Relevance of Modifying RANKL Signaling During Folliculogenesis
This trial will test whether giving denosumab, a drug that blocks RANKL, can help protect follicle development in women with infertility who are undergoing assisted reproduction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Regionshospitalet Viborg, Skive Academic / other |
| Drugs / interventions | denosumab |
| Locations | 1 site (Skive, Midt Jylland) |
| Trial ID | NCT07546552 on ClinicalTrials.gov |
What this trial studies
Researchers will give participants either denosumab or a placebo (PBS) and monitor ovarian follicle development during treatment. Outcomes will be tracked using hormone measurements, ultrasound assessments of follicle counts, and assisted reproduction cycle results where applicable. The protocol targets mechanisms of RANKL signaling that preclinical work suggests influence early folliculogenesis. The aim is to determine whether RANKL inhibition can reduce the impact of ovarian aging on fertility.
Who should consider this trial
Good fit: Women age 18 or older with a normal AMH who can give informed consent and who have not had autotransplanted ovarian tissue are the intended participants.
Not a fit: Patients who have had autotransplanted ovarian tissue or who have very low ovarian reserve are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could slow ovarian aging and increase egg yield and success rates in assisted reproduction.
How similar studies have performed: Preclinical rodent and human tissue studies have shown effects of RANKL inhibition on gonadal function and denosumab is an approved anti-RANKL drug for osteoporosis, but clinical use to modify folliculogenesis in women is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female in the age of 18 or above, Normal AMH-value, able to give concent Exclusion Criteria: * Patients who have had autotransplanted ovarian tissue
Where this trial is running
Skive, Midt Jylland
- Regionshospitalet, Skive, Midt Jylland 7800 — Skive, Midt Jylland, Denmark (Recruiting)
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.