Embryotoxicity testing of IVF disposables: how do manufacturers test?

STUDY QUESTION: How do manufacturers perform embryotoxicity testing in their quality control programs when validating IVF consumables? SUMMARY ANSWER: The Mouse Embryo Assay (MEA) and Human Sperm Survival Assay (HSSA) used for IVF disposables differed from one manufacturer to another. WHAT IS KNOWN ALREADY: Many components used in IVF laboratories, such as culture media and disposable consumables, may negatively impact human embryonic development. STUDY DESIGN, SIZE, DURATION: Through a questionnaire-based survey, the main manufacturers of IVF disposable devices were contacted during the period November to December 2018 to compare the methodology of the MEA and HSSA. We focused on catheters for embryo transfer, catheters for insemination, straws, serological pipettes, culture dishes and puncture needles used in the ART procedures. PARTICIPANTS/MATERIALS, SETTING, METHODS: We approached the manufacturers of IVF disposables and asked for details about methodology of the MEA and HSSA performed for toxicity testing of their IVF disposable devices. All specific parameters like mouse strains, number of embryos used, culture conditions (media, temperature, atmosphere), extraction protocol, subcontracting, and thresholds were registered and compared between companies. MAIN RESULTS AND THE ROLE OF CHANCE: Twenty-one companies were approached, of which only 11 answered the questionnaire. Significant differences existed in the methodologies and thresholds of the MEA and HSSA used for toxicity testing of IVF disposables. Importantly, some of these parameters could influence the sensitivity of the tests. LIMITATIONS, REASONS FOR CAUTION: Although we approached the main IVF manufacturers, the response rate was relatively low. WIDER IMPLICATIONS OF THE FINDINGS: Our study confirms the high degree of heterogeneity of the embryotoxicity tests performed by manufacturers when validating their IVF disposable devices. Currently, no regulations exist on this issue. Professionals should call for and request standardization and a future higher degree of transparency as regards embryotoxicity testing from supplying companies; moreover, companies should be urged to provide the users clear and precise information about the results of their tests and how testing was performed. Future recommendations are urgently awaited to improve the sensitivity and reproducibility of embryotoxicity assays over time. STUDY FUNDING/COMPETING INTEREST(S): This study did not receive any funding. L.D. declares a competing interest with Patrick Choay SAS. TRIAL REGISTRATION NUMBER: N/A.

[Isolated splenic metastasis of ovarian endometrioid carcinoma. A clinical case]. / Metastasi splenica isolata di un carcinoma endometrioide dell'ovaio. Caso clinico.

The authors describe a case of solitary spleen metastasis of an endometrioid ovarian cancer exceptionally reported in the literature. The follow-up of the patient is 12 months without recurrence.

[Recurrent acute hepatic steatosis in pregnancy]. / Stéatose aiguë hépatique gravidique récidivante.

Acute fatty infiltration of the liver in pregnancy (AFILP) is a rare disorder with a severe prognosis, improved by diagnosis of the minimally symptomatic form. AFILP is classically considered to be non-recurrent. We nevertheless report the fourth case of the recurrent form.

[Transvaginal colposuspension. A series of 49 cases]. / Colposuspension transvaginale. A propos d'une série de 49 cas.

UNLABELLED: Retrospective study from january 1991 to May 1993 of 49 patients undergoing transvaginal colposuspension (TVC) for urinary stress incontinence (USI). SURGICAL TECHNIQUE: 14 TVC performed using Raz's technique, including 11 with non absorbable suture material. 35 TVC were performed by longitudinal incision, including 26 with non-absorbable suture material. RESULTS: Peroperative complications: 3 accidental bladder lesions (6.1%), 2 hemorrhages during detachment of Retzius (4%). Postoperative complications: temperature over 38 degrees in 10 cases (17%), 3 urinary tract infections (5.1%), 1 phlebitis (post sacro-spino-fixation). Functional results: 3 early failures at 2 months (93.9% good results). TVC is a simple technique for dealing with USI but longer follow-up is necessary for its invalidation.

[Disseminated peritoneal leiomyomatosis. Apropos of a case]. / La léiomyomatose péritonéale disséminée. A propos d'un cas.

The authors report a case of disseminated peritoneal leiomyomatosis (DPL) occurring in a post-menopausal woman not using hormone replacement therapy. Her past history included a subtotal hysterectomy, with preservation of the adnexae, for metromenorrhagia due to a leiomyomatous uterus. This case confirms data in the literature concerning presentation, symptomatology, macroscopic appearance and histology. No electron microscopy study was undertaken, nor were hormonal receptors evaluated. The originality of this case lies in the onset of DPL in a post-menopausal (with laboratory confirmation) woman with very slow progression over several decades confirming the hormone-dependent nature and the good prognosis of this rare condition.

[Uterine rupture due to unrecognized uterine scarring]. / Rupture utérine sur utérus cicatriciel méconnu.

Uterine rupture affecting the pregnant uterus has become rare. It occurs essentially in the presence of scarring. The cases reported here described rupture following evacuation curettage which had caused an unrecognized uterine perforation. While such perforations often have no serious consequences, this explaining the usual abstention from treatment, it is nevertheless important that acute complications (intestinal or vascular trauma) or long term (uterine rupture of pregnant uterus) should not pass unrecognized.