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

NCT07201259 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-10-01

No results posted yet for this study

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.

Conditions

  • Malignant Tumors

Interventions

OTHER

No Intervention: Observational Cohort

No Intervention: Observational Cohort

Sponsors & Collaborators

  • West China Second University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-10
Primary Completion
2026-07-10
Completion
2026-10-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07201259 on ClinicalTrials.gov