ArticleDrug delivery and translational research2026
Safety evaluation of a novel progesterone vaginal ring (PVR) for luteal phase support: SARA trial.
Article in Drug delivery and translational research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
After manufacturing changes, the safety and tolerability of the progesterone vaginal ring (PVR) was compared to findings from the similarly designed phase 3 trial. This prospective, open-label, single-arm, multi-center U.S. trial was conducted with women with tubal, idiopathic, male factor, ovulatory dysfunction, or endometriosis-linked infertility. Women underwent ovarian stimulation with highly purified human menotropin 225 IU/day in a standardized long agonist protocol. Weekly administration of PVR started the day after oocyte retrieval (OR), followed by ICSI and fresh blastocyst transfer, and continued for up to 10 weeks. The primary endpoint was spontaneous abortion rate, defined as 2 positive β-hCG tests and an empty intrauterine gestational sac or lacking a fetal heartbeat, or the absence of a viable fetus up to 12 weeks after OR. 254 women were treated with PVR at 14 sites July 2018-July 2019 (mean age 30.8 years, BMI 26.5 kg/m
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