Exploring Gut Microbiome Differences in Female Cancer Patients With Varied Ovarian Function and Fertility Outcomes Following Immune Checkpoint Inhibitor Therapy

The goal of this observational study is to evaluate the impact of Immune Checkpoint Inhibitor (ICI) treatment on ovarian function and fertility, and to explore the role of gut microbiota in female cancer patients of reproductive age (18-38 years) receiving ICI therapy. The main questions it aims to answer are: Does ICI treatment alter serum hormone levels (FSH, LH, E2, P, AMH) associated with ovarian function and fertility? Are there differences in gut microbiota composition and metabolites between patients with different ovarian function and fertility outcomes after ICI treatment? What are the potential mechanisms by which gut microbiota influences ovarian function and fertility in patients receiving ICIs? Researchers will compare patients with preserved ovarian function versus those with impaired ovarian function after ICI treatment to identify differences in gut microbiota and metabolic profiles. Participants will: Provide blood samples (10 ml per collection) at enrollment and after each of the 6 treatment cycles for hormone level testing and potential future analyses. Provide stool samples at the same time points for gut microbiota metagenomic sequencing and metabolite analysis. Undergo regular clinical assessments and follow-ups as part of their standard ICI treatment.

NCT Number	NCT07201259
Lead Sponsor	West China Second University Hospital
Conditions	Malignant Tumors
Enrollment	40 participants
Start Date	2025-10-10
Primary Completion	2026-07-10 (estimated)
Study Completion	2026-10-10 (estimated)
Updated on ClinicalTrials.gov	2025-10-01