Blocking RANKL with denosumab to protect ovarian follicles
Official title: Clinical Relevance of Modifying RANKL Signaling During Folliculogenesis
Run by Regionshospitalet Viborg, Skive · NCT07546552 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | Regionshospitalet Viborg, Skive Academic / other |
| Drugs / interventions | denosumab |
| Locations | 1 site (Skive, Midt Jylland) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | March 15, 2028 |
| Study ends | March 15, 2028 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT07546552 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients who have had autotransplanted ovarian tissue or who have very low ovarian reserve are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Regionshospitalet, Skive, Midt Jylland 7800
Skive, Midt Jylland, Denmark Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.