This randomized, controlled trial verifies whether patients with recurrent failed implantation benefit from preimplantation genetic diagnosis for aneuploidy, as compared with conventional assisted reproduction treatment procedures. Two hundred patients with recurrent failed implantation were randomized into two groups. A total of 139 patients underwent ovarian stimulation, and preimplantation genetic screening was performed in 72 patients. Analysis of chromosomes X, Y, 13, 16, 18, 21 and 22 was carried out using fluorescence in-situ hybridization in blastomeres of day-3 cleavage-stage embryos in the study group. The primary endpoint was implantation rate. Secondary endpoints were embryonic morphology and chromosomal status, number of transferred embryos and clinical pregnancy rate. With regard to the implantation rate, there was no significant difference between the study group (21.4%) and the control group (25.3%). The number of embryos transferred was significantly lower in the study group, namely 1.4 (SD 1.0) versus 2.1 (SD 1.0) in the control group (P < 0.05). The clinical pregnancy rate was not significantly different between the groups (25.0% in the study group versus 40.3% in the control group). It can be concluded that preimplantation genetic screening does not increase the implantation rates after IVF-intracytoplasmic sperm injection in women with repeated implantation failure.
The evaluation of endometrial thickness (EMT) is still part of standard cycle monitoring during IVF, despite the lack of robust evidence of any value of this measurement to predict little revalidation in contemporary medical practice; other tools, however, such as endocrine profile monitoring, have become increasingly popular. The aim of this study was to reassess whether EMT affects the outcome of a fresh embryo transfer in modern-day medicine, using a retrospective, single-centre cohort of 3350 IVF cycles (2827 women) carried out between 2010 and 2014. In the multivariate regression analysis, EMT was non-linearly associated with live birth, with live birth rates being the lowest with an EMT less than 7.0 mm (21.6%; P < 0.001) and then between 7.0 mm and 9.0 mm (30.2%; P = 0.008). An EMT less than 7.0 mm was also associated with a decrease in neonatal birthweight z-scores (-0.40; 95% CI -0.69 to -0.12). In conclusion, these results reaffirm the use of EMT as a potential prognostic tool for live birth rates and neonatal birthweight in contemporary IVF, namely when considered together with other ovarian stimulation monitoring methods, such as the late-follicular endocrine profile.
STUDY QUESTIONS Does the application of anti-adhesion gel, compared to no gel, following operative hysteroscopy to treat intrauterine pathology in women wishing to conceive increase the chance of conception leading to live birth? WHAT IS KNOWN ALREADY Intrauterine adhesions (IUAs) following operative hysteroscopy may impair reproductive success in women of reproductive age. Anti-adhesion barrier gels may decrease the occurrence of IUAs, but the evidence on their effectiveness to improve reproductive outcomes is sparse and of low quality. STUDY DESIGN, SIZE, DURATION This multicentre, parallel group, superiority, blinded and pragmatic randomised controlled trial is being carried out in seven participating centres in Belgium. Recruitment started in April 2019. Women will be randomly allocated to treatment with anti-adhesion gel (intervention group) or no gel (control group). Sterile ultrasound gel will be applied into the vagina as a mock-procedure in both treatment arms. The patient, fertility physician and gynaecologist performing the second-look hysteroscopy are unaware of the allocated treatment. Power analysis, based on a target improvement of 15% in conception leading to live birth using anti-adhesion gel, a power of 85%, a significance level of 5%, and a drop-out rate of 10%, yielded a number of 444 patients to be randomised. The baseline rate of conception leading to live birth in the control group is expected to be 45%. PARTICIPANTS/MATERIALS, SETTING, METHODS Women of reproductive age (18–47 years), wishing to conceive (spontaneously or by fertility treatment) and scheduled for operative hysteroscopy to treat intrauterine pathology (endometrial polyps, myomas with uterine cavity deformation, uterine septa, IUAs or retained products of conception) are eligible for recruitment. Women may try to conceive from 3 to 6 weeks after receiving allocated treatment with follow-up ending at 30 weeks after treatment. If the woman fails to conceive within this timeframe, a second-look hysteroscopy will be scheduled within 2–6 weeks to check for IUAs. The primary endpoint is conception leading to live birth, measured at 30 weeks after randomisation. The secondary endpoints are time to conception, clinical pregnancy, miscarriage and ectopic pregnancy rates, measured at 30 weeks after receiving allocated treatment. The long-term follow-up starts when the patient is pregnant and she will be contacted every trimester. STUDY FUNDING/COMPETING INTEREST(S) This work is funded by the Belgian Healthcare Knowledge Centre (KCE). The anti-adhesion gel is supplied at no cost by Nordic Pharma and without conditions. Dr. Tomassetti reports grants and non-financial support from Merck SA, non-financial support from Ferring SA, personal fees and non-financial support from Gedeon-Richter, outside the submitted work. None of the other authors have a conflict of interest.
A 40-year-old nulliparous woman with no medical history attended our fertility center with the desire to become pregnant with sperm donation. Her ovarian reserve was moderately low (Anti-Müllerian hormone, 0.9 ng/mL; antral follicle count, 7) and she was advised to start in-vitro fertilization/intracytoplasmic sperm injection (ICSI) treatment. Two cleavage-stage embryos were transferred 3 days following oocyte retrieval. Twelve days later, serum beta-human chorionic gonadotropin (β-hCG) was positive.The first transvaginal ultrasound (TVS) scan at 7 weeks revealed an ectopic twin pregnancy, with one embryo in each cornu, both with cardiac activity. The gestational sacs (GS) were 11.6 mm and 18.5 mm in diameter ( Figure 1). Following a second TVS examination, the patient was administered a first intramuscular injection of 75 mg methotrexate (MTX) at 8 weeks, however, a second dose was indicated, as there was no decrease in β-hCG after 7 days. One week later, TVS showed evolution and viability of the right pregnancy, so it was decided to perform a TVS-guided reduction of the pregnancy. The left cornual pregnancy without viability was injected with 100 mg/mL MTX, whereas the right cornual pregnancy received an intracardiac injection of 3 mEq potassium chloride (KCl) and 150 mg/1.5 mL of MTX intragestationally, using a Towako needle set (Cook Medical, Bloomington, IN, USA). TVS performed 1 week later showed an empty and collapsed sac in the right cornu ( Figure 2). After 3 weeks, serum β-hCG was negative. A new treatment cycle with ICSI was started, which resulted in a biochemical pregnancy. In the next cycle, a thawed embryo was transferred and the patient had an ongoing eutopic pregnancy when she was last examined at 7 weeks' gestation.Cornual pregnancy occurs in 2-4% of all ectopic pregnancies, with a mortality rate of 2-3% 1 . Some studies report higher ectopic pregnancy rates after assisted reproductive technology (ART) cycles 2 , whereas others report similar ectopic implantation rates between spontaneous and assisted conception 3 . One factor contributing to ectopic pregnancy following ART cycles related to embryo implantation potential 3 . Another Figure 1 Three-dimensional ultrasound imaging of uterine fundus with gestational sacs in both cornua in transverse (a) and coronal (b) views, showing distention of the cornua and thin residual myometrium (a) and different implantation sites in each cornu (b).
Study question Does the use of virtual reality (VR) headsets in diagnostic office hysteroscopy (HSC) with endometrial biopsy (EB) reduce anxiety and pain scores in the patient? Summary answer Virtual reality during office HSC do not seem to improve relaxation, anxiety, or pain scores. Physicians have a good perception of patients’ pain. What is known already Women undergoing outpatient HSC experience high levels of preoperative anxiety, which increase pain and discomfort during the procedure. The experience of pain is a complex phenomenon, which simultaneously occurs on cognitive, emotional, and behavioural levels, and is influenced by many factors. A Cochrane review failed to show a significant difference between different types of pain relief (analgesics, local anaesthetic and verbal support techniques …). VR is a multisensory immersion providing an interactive high level distraction, occupying a large portion of humans’ finite attentional resources (vision and audio), and leaving less cognitive capacity available to process pain. Study design, size, duration The sample size for this prospective randomized controlled trial was calculated at 196 patients (98 per group), considering a power of at least 80% to detect superiority of adding a VR headset versus standard care, standard deviation (SD = 2.0), using a two-sided, t-test, at significance level alpha of 0.05. The preliminary results after 1 month include a sample of 48 patients: 25 in the VR group and 23 controls. Participants/materials, setting, methods All 48 patients suffer subfertility and underwent HSC with EB at our tertiary-care fertility center. We used Oncomfort®, a commercially available VR autohypnosis relaxation program designed for perioperative settings. The headmounted smartphone display with headphones provides image sound distraction with suggestive hypnosis techniques incorporated. Before and immediately after the exam, both patients and surgeons fill out a questionnaire using the 10.0cm visual analog scale (VAS). Main results and the role of chance The mean duration of HSC was 3min43sec in the VR group, (range 2–6min), compared to 4min50 in the control group (range 1–12minutes), which was not significantly different (p = 0.09). Subjective variables of stress, anxiety and pain were evaluated at four different time points, i.e. before, during, immediately after HSC and one week later. According to VAS, stress levels did not differ significantly (p > 0.05) between the VR group and the control group, or within time: 5.08 to 5.36 to 3.08 vs 4.48 to 4.83 to 2.48 before, during and after HSC respectively. Fear levels prior to HSC at 4.28 for VR patients and 3.52 for controls did not increase significantly during HSC in both groups: 4.44 vs 4.17. During HSC, pain levels increased from 1.40 to 4.720 in the VR group vs 0.65 to 4.109 (NS) in the controls, to decrease again afterwards to 2.60 vs 2.17 (NS) respectively. Physicians rated the average pain levels of VR patients as 3.32 compared to 3.0 for controls, which was significantly correlated to patients’ perception (p < 0,005). Patients gave a positive rating to the VR experience (satisfaction score 7.17). Limitations, reasons for caution These are preliminary results, evaluating only a fourth of the required sample. A population selection bias could exist, as recruited patients were willing to accept VR. The very short induction period of 2 minutes could influence the effect of (immersiveness into) VR. Wider implications of the findings: Pain management in ambulatory procedures should be multimodal and should include both pharmacological and non-pharmacological interventions. Introducing VR might increase patient tolerance for longer or more painful procedures. Offering a range of options will increase the spectrum of successful procedures in the outpatient setting and improve patient experience. Trial registration number B.U.N. 1432020000050
Study question Does the use of virtual reality (VR) headsets in diagnostic office hysteroscopy (HSC) with endometrial biopsy (EB) reduce anxiety and pain scores in the patient? Summary answer Virtual reality during office HSC do not seem to improve relaxation, anxiety, or pain scores. Physicians have a good perception of patients’ pain. What is known already Women undergoing outpatient HSC experience high levels of preoperative anxiety, which increase pain and discomfort during the procedure. The experience of pain is a complex phenomenon, which simultaneously occurs on cognitive, emotional, and behavioural levels, and is influenced by many factors. A Cochrane review failed to show a significant difference between different types of pain relief (analgesics, local anaesthetic and verbal support techniques …). VR is a multisensory immersion providing an interactive high level distraction, occupying a large portion of humans’ finite attentional resources (vision and audio), and leaving less cognitive capacity available to process pain. Study design, size, duration The sample size for this prospective randomized controlled trial was calculated at 196 patients (98 per group), considering a power of at least 80% to detect superiority of adding a VR headset versus standard care, standard deviation (SD = 2.0), using a two-sided, t-test, at significance level alpha of 0.05. The preliminary results after 1 month include a sample of 48 patients 25 in the VR group and 23 controls. Participants/materials, setting, methods All 48 patients suffer subfertility and underwent HSC with EB at our tertiary-care fertility center. We used Oncomfort®, a commercially available VR autohypnosis relaxation program designed for perioperative settings. The headmounted smartphone display with headphones provides image sound distraction with suggestive hypnosis techniques incorporated. Before and immediately after the exam, both patients and surgeons fill out a questionnaire using the 10.0cm visual analog scale (VAS). Main results and the role of chance The mean duration of HSC was 3min43sec in the VR group, (range 2-6min), compared to 4min50 in the control group (range 1-12minutes), which was not significantly different (p = 0.09). Subjective variables of stress, anxiety and pain were evaluated at four different time points, i.e. before, during, immediately after HSC and one week later. According to VAS, stress levels did not differ significantly (p > 0.05) between the VR group and the control group, or within time 5.08 to 5.36 to 3.08 vs 4.48 to 4.83 to 2.48 before, during and after HSC respectively. Fear levels prior to HSC at 4.28 for VR patients and 3.52 for controls did not increase significantly during HSC in both groups: 4.44 vs 4.17. During HSC, pain levels increased from 1.40 to 4.720 in the VR group vs 0.65 to 4.109 (NS) in the controls, to decrease again afterwards to 2.60 vs 2.17 (NS) respectively. Physicians rated the average pain levels of VR patients as 3.32 compared to 3.0 for controls, which was significantly correlated to patients’ perception (p < 0,005). Patients gave a positive rating to the VR experience (satisfaction score 7.17). Limitations, reasons for caution These are preliminary results, evaluating only a fourth of the required sample. A population selection bias could exist, as recruited patients were willing to accept VR. The very short induction period of 2 minutes could influence the effect of (immersiveness into) VR. Wider implications of the findings Pain management in ambulatory procedures should be multimodal and should include both pharmacological and non-pharmacological interventions. Introducing VR might increase patient tolerance for longer or more painful procedures. Offering a range of options will increase the spectrum of successful procedures in the outpatient setting and improve patient experience. Trial registration number B.U.N. 1432020000050
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