Assisted Reproduction · Registries and Reporting
RRM Academy Synopsis
Ovarian hyperstimulation led France's 2021 ART adverse-effect reports
France's 2021 vigilance report finds ovarian hyperstimulation the top adverse effect of assisted reproduction. Centers sent in 450 declarations. Of these, 322 were reports of adverse effects. Ovarian hyperstimulation made up 175 of the 345 coded adverse effects. Another 103 declarations described incidents, most often in laboratory preparation and culture.
Key Findings
- The Agence de la biomédecine received 450 declarations from 83 centers in 2021; 425 fell within vigilance scope: 322 adverse-effect declarations, 100 incident declarations and 3 linked incidents and adverse effects.
- Reproductive organ and breast disorders made up about 55% of coded adverse effects (189/345); ovarian hyperstimulation syndrome accounted for 175 of those 189 (92.6%) and adnexal torsion for 14 (7.4%).
- Vascular disorders made up 29.6% (102 cases) of adverse effects. Hemoperitoneum after ovarian puncture numbered 86 cases, 84% of vascular events and 24.9% of adverse effects.
- Serious adverse effects, graded G3 or higher, numbered 317 (97.5%); 95.4% of adverse effects led to hospitalization, and hospital stays averaged 3.8 days with a median of 3 days.
- Incident declarations (103) arose mainly during preparation and culture (45, 43.7%), collection (28, 27.2%) and clinical use (19, 18.4%). Confirmed loss of gametes, embryos or germinal tissue occurred in 58 incidents.
Interpretation
The report summarizes declarations that local correspondents at each center send to the national agency. The declared events have no comparison group, and the report gives no success rates for the treatments. The agency states that declared adverse effects are not exhaustive, so calculated rates cannot reflect an exact proportion. The agency notes that its earlier declaration-only system showed substantial underreporting. In 2021, 26 clinical-biological centers (about 24.8% of centers) filed no declaration. The report states that lower hyperstimulation counts in 2020 and 2021 than in 2019 may reflect pandemic disruption, prevention measures and less frequent declaration of an expected event.
RRM Context
Restorative reproductive medicine (RRM) treats the cause of infertility. RRM works with the body's own function and starts with evaluation of both partners. The harms listed in this report include ovarian hyperstimulation, bleeding after egg retrieval and handling errors in the laboratory. These arise in procedures that go around the reproductive system, while RRM restores its function.
Abstract
This annual report of the Agence de la biomédecine on the vigilance system for medically assisted procreation (AMP vigilance) presents the vigilance declarations received in 2021 and the actions carried out that year. The Agence received 450 AMP vigilance declarations from 83 AMP centres in 2021, including 103 declarations of incidents. The report states that 345 adverse effects were reported for 322 declarations of adverse effects in 2021. The introduction states that the AMP vigilance system now rests on two components: the declaration of serious and unexpected events by AMP professionals, and the surveillance of certain expected events through an exploration of the système national des données de santé (SNDS).
