NCT07546552 Clinical Relevance of Modifying RANKL Signaling During Folliculogenesis
| NCT ID | NCT07546552 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peter Humaidan |
| Condition | Female Infertility |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2028-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-08-01 with a primary completion date of 2028-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Female infertility presents a significant societal challenge that will be aggravated in the future due to delayed parenthood. Our translational research suggests that receptor activator of NF-κB ligand (RANKL) is a novel treatment target, during assisted reproductive techniques and that inhibition of this pathway may reduce the impact of aging on the ovary. RANKL is a regulator of bone health, and an antibody (denosumab) blocking RANKL activity is used clinically to treat osteoporosis. Previously, we have shown that inhibition of RANKL increases sperm production in rodents, in human tissue models, and in a subpopulation of infertile men. Now, we show that all factors of the RANKL signalling system are expressed in human and mouse ovaries. Granulosa cell-specific Rankl knockdown lowers the number of primordial follicles, which suggests that RANKL has an important role during early stages of folliculogenesis. Additionally, our data from women undergoing in vitro fertilisation show that follicular fluid concentrations of RANKL and OPG are associated with age and the number of matured follicles, and RANKL inhibition promoted maturation of human oocytes in vitro, which suggests an effect also late in folliculogenesis. Thus, the proposed project aims to: 1) Clarify the role of RANKL in ovaries of mice and humans 2) Determine the reproductive effect of modulating RANKL activity systemically or locally in mice and monkeys 3) Investigate whether manipulation of RANKL can optimise in vitro maturation and rescue of immature human oocytes and 4) Determine whether follicular fluid concentrations of soluble RANKL and OPG may serve as markers of ovarian pathophysiology. The overall aim of this project is to uncover how RANKL regulates follicle reserve and oocyte maturation during the final stages of follicle development. Thereby, determining whether this pathway may be a target for optimisation of IVF treatment and a future treatment option for female infertility.
Eligibility 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
Frequently Asked Questions
Who can join the NCT07546552 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Female Infertility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07546552 currently recruiting?
Yes, NCT07546552 is actively recruiting participants. Visit ClinicalTrials.gov or contact Peter Humaidan to inquire about joining.
Where is the NCT07546552 trial being conducted?
This trial is being conducted at Skive, Denmark.
Who is sponsoring the NCT07546552 clinical trial?
NCT07546552 is sponsored by Peter Humaidan. The trial plans to enroll 100 participants.