Trial reportPloS one2012
Low-dose oral sirolimus and the risk of menstrual-cycle disturbances and ovarian cysts: analysis of the randomized controlled SUISSE ADPKD trial.
Trial report in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00346918 (Sirolimus), which is not on this map. Cited by 17 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Sirolimus (Rapamune®) for Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD): a Randomized Controlled Study.
Who cites it
17 citing papers in PubMed, 3 syntheses or guidelines pooled it, 40 citations in OpenAlex.
- Interventions for preventing the progression of autosomal dominant polycystic kidney disease.The Cochrane database of systematic reviews · 2024Pooled it
- Pooled it
- Interventions for preventing the progression of autosomal dominant polycystic kidney disease.The Cochrane database of systematic reviews · 2015Pooled it
- Reproductive considerations in patients undergoing treatment for complex lymphatic anomalies.Journal of vascular anomalies · 2026Article
- Sirolimus treatment for intractable lymphatic anomalies: an open-label, single-arm, multicenter, prospective trial.Frontiers in medicine · 2024Article
- Cancer Treatment-Related Ovarian Dysfunction in Women of Childbearing Potential: Management and Fertility Preservation Options.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Review
- Potential ovarian toxicity and infertility risk following targeted anti-cancer therapies.Reproduction & fertility · 2022Review
- Expanding Our Knowledge of Menstrual Irregularities Reported by Females With Tuberous Sclerosis Complex.Frontiers in reproductive health · 2022Article
- Efficacy and safety of low-dose everolimus treatment for renal angiomyolipoma associated with tuberous sclerosis complex.International journal of clinical oncology · 2021Article
- Metabolic Reprogramming and Reconstruction: Integration of Experimental and Computational Studies to Set the Path Forward in ADPKD.Frontiers in medicine · 2021Review
- Role of mTOR Signaling in Female Reproduction.Frontiers in endocrinology · 2019Review
- Immunosuppression in pregnant women with renal disease: review of the latest evidence in the biologics era.Journal of nephrology · 2018Review
- Treatment of renal angiomyolipoma in tuberous sclerosis complex (TSC) patients.Pediatric nephrology (Berlin, Germany) · 2017Review
- The Role and Application of Sirtuins and mTOR Signaling in the Control of Ovarian Functions.Cells · 2016Review
- Review
- Immunosuppressive drugs and fertility.Orphanet journal of rare diseases · 2015Review
- Lymphangioleiomyomatosis: differential diagnosis and optimal management.Therapeutics and clinical risk management · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
unlabelledSirolimus has been approved for clinical use in non proliferative and proliferative disorders. It inhibits the mammalian target of rapamycin (mTOR) signaling pathway which is also known to regulate ovarian morphology and function. Preliminary observational data suggest the potential for ovarian toxicity but this issue has not been studied in randomized controlled trials. We reviewed the self-reported occurrence of menstrual cycle disturbances and the appearance of ovarian cysts post hoc in an open label randomized controlled phase II trial conducted at the University Hospital Zürich between March 2006 and March 2010. Adult females with autosomal dominant polycystic kidney disease, an inherited kidney disease not known to affect ovarian morphology and function, were treated with 1.3 to 1.5 mg sirolimus per day for a median of 19 months (N = 21) or standard care (N = 18). Sirolimus increased the risk of both oligoamenorrhea (hazard ratio [HR] 4.3, 95% confidence interval [CI] 1.1 to 29) and ovarian cysts (HR 4.4, CI 1.1 to 26); one patient was cystectomized five months after starting treatment with sirolimus. We also studied mechanisms of sirolimus-associated ovarian toxicity in rats. Sirolimus amplified signaling in rat ovarian follicles through the pro-proliferative phosphatidylinositol 3-kinase pathway. Low dose oral sirolimus increases the risk of menstrual cycle disturbances and ovarian cysts and monitoring of sirolimus-associated ovarian toxicity is warranted and might guide clinical practice with mammalian target of rapamycin inhibitors.
trial registrationClinicalTrials.gov NCT00346918.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.