Clinical outcomes of uninterrupted embryo culture with or without time-lapse-based embryo selection versus interrupted standard culture (SelecTIMO): a three-armed, multicentre, double-blind, randomised controlled trial.

BACKGROUND: Time-lapse monitoring is increasingly used in fertility laboratories to culture and select embryos for transfer. This method is offered to couples with the promise of improving pregnancy chances, even though there is currently insufficient evidence for superior clinical results. We aimed to evaluate whether a potential improvement by time-lapse monitoring is caused by the time-lapse-based embryo selection method itself or the uninterrupted culture environment that is part of the system. METHODS: In this three-armed, multicentre, double-blind, randomised controlled trial, couples undergoing in-vitro fertilisation or intracytoplasmic sperm injection were recruited from 15 fertility clinics in the Netherlands and randomly assigned using a web-based, computerised randomisation service to one of three groups. Couples and physicians were masked to treatment group, but embryologists and laboratory technicians could not be. The time-lapse early embryo viability assessment (EEVA; TLE) group received embryo selection based on the EEVA time-lapse selection method and uninterrupted culture. The time-lapse routine (TLR) group received routine embryo selection and uninterrupted culture. The control group received routine embryo selection and interrupted culture. The co-primary endpoints were the cumulative ongoing pregnancy rate within 12 months in all women and the ongoing pregnancy rate after fresh single embryo transfer in a good prognosis population. Analysis was by intention to treat. This trial is registered on the ICTRP Search Portal, NTR5423, and is closed to new participants. FINDINGS: 1731 couples were randomly assigned between June 15, 2017, and March 31, 2020 (577 to the TLE group, 579 to the TLR group, and 575 to the control group). The 12-month cumulative ongoing pregnancy rate did not differ significantly between the three groups: 50·8% (293 of 577) in the TLE group, 50·9% (295 of 579) in the TLR group, and 49·4% (284 of 575) in the control group (p=0·85). The ongoing pregnancy rates after fresh single embryo transfer in a good prognosis population were 38·2% (125 of 327) in the TLE group, 36·8% (119 of 323) in the TLR group, and 37·8% (123 of 325) in the control group (p=0·90). Ten serious adverse events were reported (five TLE, four TLR, and one in the control group), which were not related to study procedures. INTERPRETATION: Neither time-lapse-based embryo selection using the EEVA test nor uninterrupted culture conditions in a time-lapse incubator improved clinical outcomes compared with routine methods. Widespread application of time-lapse monitoring for fertility treatments with the promise of improved results should be questioned. FUNDING: Health Care Efficiency Research programme from Netherlands Organisation for Health Research and Development and Merck.

[Pelvic inflammatory disease and an abscessed endometriosis cyst: a diagnostic problem and a therapeutic dilemma]. / 'Pelvic inflammatory disease' en een geabcedeerde endometriosecyste: een diagnostisch probleem en een therapeutisch dilemma.

A 52-year-old woman with known endometriosis was treated with a levonorgestrel-containing IUD for irregular vaginal blood loss. Two weeks later she was admitted with signs ofpelvic inflammatory disease (PID) and was treated with antibiotics. As no clinical improvement ensued, laparoscopy was performed which demonstrated an infected endometriosis cyst in her right ovary. Ovariectomy was performed. In a 29-year-old woman with a symptomatic endometriosis cyst in the right ovary, PID was also suspected. After an initially good response to antibiotic therapy her condition deteriorated. Laparotomy revealed an infected endometriosis cyst. It was drained with subsequent cystectomy. A third, 43-year-old, woman with known endometriosis was admitted with signs of PID. Although she had a good clinical response to antibiotic therapy, her C-reactive protein (CRP) level remained elevated. Diagnostic laparoscopy demonstrated a large abscess in the right ovary. Ovariectomy was performed. Histology showed signs of an infected endometriosis cyst. All these women presented with PID and, in addition, a cystic adnexal mass on ultrasonography. The incidence oftubo-ovarian and ovarian abscesses is higher in the presence of an endometriosis cyst. Irrespective of the presence of an endometriosis cyst, antibiotics should be the first line of treatment. Reduction in the size of the abscess is not a useful parameter for monitoring conservative treatment when an infected endometriosis cyst is present. If it is decided to perform surgery on the infected endometriosis cyst, drainage of the abscess is usually not sufficient: excision of the endometriosis cyst is the only adequate therapy.