Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT07201259
Brief Summary:
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.
Study:
NCT07201259
Study Brief:
Protocol Section:
NCT07201259