Kisspeptin-10 in polycystic ovary syndrome — evidence extract
The Institute's graded assessment of Kisspeptin-10 for polycystic ovary syndrome, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Polycystic ovary syndrome
§1.1Question and anchor outcome
- Population
- A reproductive-endocrine disorder defined by combinations of ovulatory dysfunction, clinical or biochemical hyperandrogenism, and polycystic ovarian morphology.
- Intervention
- Kisspeptin-10, intravenous infusion and subcutaneous in clinical research
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- Change in body weight
Additional outcomes the Institute extracts for this indication: Menstrual cyclicity; Change in free androgen index; Change in HOMA-IR; Ovulation and live-birth rate.
§1.2Contributing trials
Table 1. Trials contributing to the assessment of Kisspeptin-10 in polycystic ovary syndrome.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| KISS-IVF-TRIGGER | 2 | Single-arm open-label | 60 | Single cycle | 2014 |
| KISS-DIAGNOSTIC | 1 | Diagnostic accuracy | — | Single test | 2011 |
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | No concern | No serious concern identified in this domain. |
| Inconsistency | No concern | No serious concern identified in this domain. |
| Indirectness | Serious | The outcome is a surrogate whose relationship to the clinical outcome is unvalidated for this indication. |
| Imprecision | No concern | No serious concern identified in this domain. |
| Publication bias | Serious | Registered trials without posted results were identified for this question. |
| Overall rating: Low certainty. Confidence in the effect estimate is limited. The true effect may be substantially different from the estimate. | ||
§1.4What this extract does not establish
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
- Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. Stability of protein pharmaceuticals: an update. Pharmaceutical Research 2010;27(4):544–575. doi:10.1007/s11095-009-0045-6 · PMID 20143256
- Clayton AH, Althof SE, Kingsberg S, DeRogatis LR, Kroll R, Goldstein I, Kaminetsky J, Spana C, Lucas J, Jordan R, Portman DJ. Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial. Women’s Health 2016;12(3):325–337. doi:10.2217/whe-2016-0018 · PMID 27638896
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.