Trial · NCT07904208
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of treatment-emergent adverse events (TEAEs), including hyperglycemia, stomatitis/mucositis, and diarrhea | 3 months | Proportion of participants experiencing any TEAE, serious adverse event (SAE), and AEs of special interest (fasting glucose elevation, oral stomatitis/mucositis, diarrhea), graded by CTCAE v5.0. Fasting glucose will be monitored weekly during the first month after treatment initiation; other AEs will be captured throughout the 3-month follow-up. |
| Primary | Change in total antral follicle count (AFC) from baseline to 3 months after treatment initiation | Baseline and 3 months | Total AFC (both ovaries) assessed by transvaginal ultrasound. Baseline AFC will be recorded during screening (D-28 to D-1). |
| Secondary | Proportion of participants with ≥1 antral follicle | Baseline and 3 months | Measured by ultrasound |
| Secondary | Proportion of participants with ≥1 dominant follicle | Baseline and 3 months | Measured by ultrasound |
| Secondary | Change in ovarian volume | Baseline and 3 months | Measured by ultrasound |
| Secondary | Change in serum FSH, LH levels (IU/L) | Baseline and 3 months | Change in serum FSH, LH levels (IU/L) |
| Secondary | Proportion of participants achieving FSH <25 IU/L | 3 months | Proportion of participants achieving FSH \<25 IU/L |
| Secondary | Proportion of participants with ≥1 spontaneous menses (non-HRT-induced) | 3 months | Proportion of participants with ≥1 spontaneous menses (non-HRT-induced) |
| Secondary | IVF outcomes, if applicable: oocytes retrieved, transferable embryos, good-quality embryos, pregnancy outcomes | through study completion, an average of 1 year | IVF outcomes, if applicable: oocytes retrieved, transferable embryos, good-quality embryos, pregnancy outcomes |
| Secondary | Change in serum E2 levels (pmol/L) | Baseline and 3 months | Change in serum E2 levels (pmol/L) |
| Secondary | Change in serum AMH levels (ng/ml) | Baseline and 3 months | Change in serum AMH levels (ng/ml) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT07904208/registered