Active — Not RecruitingEarly Phase 1

The Influence of Gut Microbiota on Ovarian Function: A Single-center, Randomized,Double Blind, Parallel-controlled, Exploratory Clinical Trial

China60 participantsStarted 2025-03-01

Plain-language summary

In order to study the community profile of the intestinal microbiome in women with ovarian dysfunction, as well as the relationship between the changes in the intestinal microbiota and sex hormones, this study recruited 30 women with ovarian dysfunction and 30 healthy women. Sequencing was performed on the V3-V4 region of the 16S rDNA gene in fecal samples, and blood serum of the patients was collected for the study of changes in the systemic metabolome to reveal the significant differences in the intestinal microbiota between the subjects with ovarian dysfunction and the control group, as well as the related metabolic pathways.

Who can participate

Age range18 Years – 39 Years

SexFEMALE

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Inclusion criteria

✓. Women have normal ovarian function;
✓. No history of menstrual irregularity and infertility;
✓. Regular menstruation;
✓. Normal FSH levels (\< 10 IU/L);
✓. Age (\< 40 years old) and body mass index (within the normal range 18.5 kg/m² ≤ BMI \< 24 kg/m²) are matched with the case group; (The matching settings for the case group and the control group have been completed);

What they're measuring

gonadal hormone concentrations

Timeframe: After taking the medicine for three months

Number of antral follicles

Timeframe: After taking the medicine for three months

Trial details

NCT IDNCT07308327

SponsorSongling Zhang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Premature Ovarian Failure (POF) trials