The strength of evidence supporting luteal phase progestogen after assisted reproduction: A systematic review with reference to trial registration and pre-specified endpoints
| Autor: | Sutham Suthaporn, Jim G Thornton, Kate F. Walker, Kanna Jayaprakasan, Walid E. Maalouf |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Non-Randomized Controlled Trials as Topic Pregnancy Rate Reproductive Techniques Assisted medicine.medical_treatment Fertilization in Vitro Luteal Phase Luteal phase Placebo Miscarriage 03 medical and health sciences 0302 clinical medicine Pregnancy medicine Humans 030212 general & internal medicine reproductive and urinary physiology Randomized Controlled Trials as Topic 030219 obstetrics & reproductive medicine In vitro fertilisation Assisted reproductive technology Progestogen Obstetrics business.industry Obstetrics and Gynecology medicine.disease Clinical trial Treatment Outcome Reproductive Medicine Female Progestins business hormones hormone substitutes and hormone antagonists |
| Zdroj: | European Journal of Obstetrics & Gynecology and Reproductive Biology. 245:149-161 |
| ISSN: | 0301-2115 |
| Popis: | Objective To measure the potential for outcome switching and selective reporting, in trials of luteal phase progestogen in assisted reproduction. Study Design Trials identified through Medline and Embase in August 2017 using the MeSH term “assisted reproductive technology, luteal phase support” and associated text words. Randomised controlled trials (RCTs) comparing progestogen of any type, dose, and route of administration, with placebo or no treatment as luteal phase support in subfertile women undergoing in vitro fertilization (IVF) or intrauterine insemination (IUI). Eight trials after IVF and eleven after IUI, involving 1040 and 2764 participants respectively, were included. Results None of the eight trials of progestogen therapy after IVF had been registered. Only 5/11 trials of progestogen after IUI had been registered, and only two of these prospectively. One of these had a registered primary outcome of “pregnancy sac plus heartbeat”, but reported “pregnancy sac alone”; we judged this as an altered primary outcome. Three other trial had a registered primary outcome of “clinical pregnancy undefined” and reported “intra or extra-uterine pregnancy with a heartbeat”; we judged this alteration as minimal. That trial was negative. Overall, 26 different outcomes had been reported by the various trials. The three outcomes reported most often were pregnancy undefined (9/19), miscarriage (11/19) and clinical pregnancy (9/19). This suggests considerable potential for selective outcome reporting or outcome switching. Conclusion Apart from one negative trial, none of the evidence on luteal phase progestogen after assisted reproduction comes from prospectively registered trials: a slender reed indeed. |
| Databáze: | OpenAIRE |
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