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.
Informed consent must be obtained and documented at the research center prior to initiating any trial procedures.
Female patients aged 18-38 years.
Patients with histologically confirmed solid tumors or soft tissue sarcomas diagnosed via open surgery, laparoscopic surgery, or core needle biopsy.
Patients scheduled to receive ICIs therapy or combination therapy including ICIs;
Individuals involved in the planning or implementation of the study;
Concurrent use of other tumor treatment modalities during the study, including but not limited to: chemotherapy, radiotherapy, immunotherapy, microbial therapy, traditional Chinese medicine, and other investigational therapies;
History of bilateral ovarian-related surgery;
Patients with prior radiotherapy or chemotherapy causing irreversible damage to ovarian function;
Female patients with malignant tumors scheduled to receive ICI or combination therapy including ICI at the Department of Biological Therapy, West China Hospital, Sichuan University between September 2025 and May 2026
Cohort
Prospective
No Intervention: Observational Cohort
Other interventionNo Intervention: Observational Cohort
Follicle-stimulating hormone
Serum levels of Follicle-stimulating hormone
Luteinizing hormone
Serum levels of Luteinizing hormone
Estradiol
Serum levels of Estradiol
Progesterone
Serum levels of Progesterone
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This trial is not recruiting at the moment. You can still explore other options:
