| 1. |
- Ahlström, Aisling, 1976, et al.
(författare)
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A double-blind randomized controlled trial investigating a time-lapse algorithm for selecting Day 5 blastocysts for transfer
- 2022
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Ingår i: Human Reproduction. - : Oxford University Press (OUP). - 0268-1161 .- 1460-2350. ; 37:4, s. 708-717
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Tidskriftsartikel (refereegranskat)abstract
- STUDY QUESTION Can use of a commercially available time-lapse algorithm for Day 5 blastocyst selection improve pregnancy rates compared with morphology alone? SUMMARY ANSWER The use of a time-lapse selection model to choose blastocysts for fresh single embryo transfer on Day 5 did not improve ongoing pregnancy rate compared to morphology alone. WHAT IS KNOWN ALREADY Evidence from time-lapse monitoring suggests correlations between timing of key developmental events and embryo viability. No good quality evidence exists to support improved pregnancy rates following time-lapse selection. STUDY DESIGN, SIZE, DURATION A prospective multicenter randomized controlled trial including 776 randomized patients was performed between 2018 and 2021. Patients with at least two good quality blastocysts on Day 5 were allocated by a computer randomization program in a proportion of 1:1 into either the control group, whereby single blastocysts were selected for transfer by morphology alone, or the intervention group whereby final selection was decided by a commercially available time-lapse model. The embryologists at the time of blastocyst morphological scoring were blinded to which study group the patients would be randomized, and the physician and patients were blind to which group they were allocated until after the primary outcome was known. The primary outcome was number of ongoing pregnancies in the two groups. PARTICIPANTS/MATERIALS, SETTING, METHODS From 10 Nordic IVF clinics, 776 patients with a minimum of two good quality blastocysts on Day 5 (D5) were randomized into one of the two study groups. A commercial time-lapse model decided the final selection of blastocysts for 387 patients in the intervention (time-lapse) group, and blastocysts with the highest morphological score were transferred for 389 patients in the control group. Only single embryo transfers in fresh cycles were performed. MAIN RESULTS AND THE ROLE OF CHANCE In the full analysis set, the ongoing pregnancy rate for the time-lapse group was 47.4% (175/369) and 48.1% (181/376) in the control group. No statistically significant difference was found between the two groups: mean difference -0.7% (95% CI -8.2, 6.7, P = 0.90). Pregnancy rate (60.2% versus 59.0%, mean difference 1.1%, 95% CI -6.2, 8.4, P = 0.81) and early pregnancy loss (21.2% versus 18.5%, mean difference 2.7%, 95% CI -5.2, 10.6, P = 0.55) were the same for the time-lapse and the control group. Subgroup analyses showed that patient and treatment characteristics did not significantly affect the commercial time-lapse model D5 performance. In the time-lapse group, the choice of best blastocyst changed on 42% of occasions (154/369, 95% CI 36.9, 47.2) after the algorithm was applied, and this rate was similar for most treatment clinics. LIMITATIONS, REASONS FOR CAUTION During 2020, the patient recruitment rate slowed down at participating clinics owing to coronavirus disease-19 restrictions, so the target sample size was not achieved as planned and it was decided to stop the trial prematurely. The study only investigated embryo selection at the blastocyst stage on D5 in fresh IVF transfer cycles. In addition, only blastocysts of good morphological quality were considered for transfer, limiting the number of embryos for selection in both groups: also, it could be argued that this manual preselection of blastocysts limits the theoretical selection power of time-lapse, as well as restricting the results mainly to a good prognosis patient group. Most patients were aimed for blastocyst stage transfer when a minimum of five zygotes were available for extended culture. Finally, the primary clinical outcome evaluated was pregnancy to only 6-8 weeks. WIDER IMPLICATIONS OF THE FINDINGS The study suggests that time-lapse selection with a commercially available time-lapse model does not increase chance of ongoing pregnancy after single blastocyst transfer on Day 5 compared to morphology alone. STUDY FUNDING/COMPETING INTEREST(S) The study was financed by a grant from the Swedish state under the ALF-agreement between the Swedish government and the county councils (ALFGBG-723141). Vitrolife supported the study with embryo culture dishes and culture media. During the study period, T.H. changed his employment from Livio AB to Vitrolife AB. All other authors have no conflicts of interests to disclose. DATE OF FIRST PATIENT'S ENROLMENT 11 June 2018.
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| 2. |
- Armstrong, P. M., et al.
(författare)
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Prevalence of Vitamin D Insufficiency and Its Determinants among Women Undergoing In Vitro Fertilization Treatment for Infertility in Sweden
- 2023
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Ingår i: Nutrients. - 2072-6643. ; 15:12
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Tidskriftsartikel (refereegranskat)abstract
- There is a lack of research on women with infertility in the northern latitudes, where vitamin D insufficiency is high. Therefore, this study aimed to assess the prevalence and determinants of vitamin D insufficiency (serum 25(OH)D concentration < 50 nmol/L) among women undergoing in vitro fertilization (IVF) treatment. Thus, 265 women scheduled for IVF/intracytoplasmic sperm injection (ICSI) between September 2020 and August 2021 at Sahlgrenska University Hospital in Gothenburg, Sweden, were included. Data on serum 25(OH)D concentration, vitamin D intake, and sun exposure were collected via questionnaires and blood samples. Approximately 27% of the women had 25(OH)D insufficiency, which was associated with longer infertility duration. The likelihood of insufficiency was higher among women from non-Nordic European countries (OR 2.92, 95% CI 1.03-8.26, adjusted p = 0.043), the Middle East (OR 9.90, 95% CI 3.32-29.41, adjusted p < 0.001), and Asia (OR 5.49, 95% CI 1.30-23.25, adjusted p = 0.020) than among women from Nordic countries. Women who did not use vitamin D supplements were more likely to have insufficiency compared with supplement users (OR 3.32, 95% CI 1.55-7.10, adjusted p = 0.002), and those who avoided sun exposure had higher odds of insufficiency compared to those who stayed "in the sun all the time" (OR 3.24, 95% CI 1.22-8.62, adjusted p = 0.018). Women with infertility in northern latitudes and those from non-Nordic countries who avoid sun exposure and do not take vitamin supplements have a higher prevalence of 25(OH)D insufficiency and longer infertility duration.
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| 3. |
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| 4. |
- Einarsson, Snorri, 1973, et al.
(författare)
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No effect of weight intervention on perinatal outcomes in obese women scheduled for in vitro fertilization treatment
- 2019
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Ingår i: Acta Obstetricia et Gynecologica Scandinavica. - : Wiley. - 0001-6349 .- 1600-0412. ; 98:6, s. 708-714
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Tidskriftsartikel (refereegranskat)abstract
- Introduction Large observational studies have shown that obstetric and perinatal outcomes are negatively affected in obese women. In contrast, a recent Dutch randomized trial of infertile women and lifestyle weight intervention found no difference between the weight intervention group and the control group in obstetric or neonatal outcomes. We have recently published a large Nordic randomized trial where obese women scheduled for in vitro fertilization (IVF) treatment went through an intensive weight intervention treatment before IVF. No significant effect on live birth rate was found, despite large weight loss in the intervention group. The present study was conducted primarily to find out the effect of weight intervention in obese women scheduled for IVF on mean birthweight and mean deviation from expected birthweight, and secondarily the effect on other perinatal and maternal outcomes. Material and methods A secondary analysis of a prospective, randomized controlled trial performed between 2010 and 2016 in the Nordic countries was performed. In all, 317 women were randomized either to weight reduction and IVF treatment (n = 160) or IVF only (n = 157) and the primary end‐point was live birth. From this study, all births were analyzed for perinatal and maternal outcomes. Nine infertility clinics participated, including women < 38 years of age planning for IVF, and having a body mass index ≥ 30 and < 35 kg/m2. Data concerning perinatal and maternal outcomes were gathered from maternal health‐care and delivery records for mother and child. All analyses were performed on singletons only. Results There were 87 live births, 45 singletons in the intervention group and 41 singletons and one twin birth in the control group. The maternal characteristics for the women having a live birth were comparable in the two groups. The primary outcomes, mean birthweight, in the weight intervention and IVF group and the IVF only group were; 3486 g (standard deviation [SD] 523) vs 3584 g (SD 509) (P = 0.46), mean difference −98.6 g (95% confidence interval [CI] −320.3 to 123.2); deviation from expected birthweight 0.25% (SD 10.4) vs 0.87% (SD 12.9), mean difference 1.1% (95% CI −6.1 to 3.9). The estimates of the secondary perinatal and maternal outcomes in the 2 groups were: preterm birth < 37 weeks 2 (4.4%) vs 1 (2.4%) (odds ratio [OR] 1.95; 95% CI 0.17‐22.36), small‐for‐gestational‐age 0 (0%) vs 1 (2.4%), mean gestational age (days) 278 vs 280 (P = 0.95), preeclampsia 5 (11.1%) vs 4 (9.8%) (OR 1.19; 95% CI 0.30‐4.76), cesarean section 13 (28.9%) vs 10 (24.4%) (OR 1.14; 95% CI 0.45‐2.94). Conclusions The outcomes in both groups were generally good. There are no indications that weight intervention in this setting, in infertile women with obesity WHO class 1 undergoing IVF, has a negative impact on mean birthweight and deviation from expected birthweight. However, the data are not sufficiently robust to draw firm conclusions concerning other outcomes.
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| 5. |
- Einarsson, Snorri, 1973, et al.
(författare)
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Weight reduction intervention for obese infertile women prior to IVF: a randomized controlled trial.
- 2017
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Ingår i: Human reproduction (Oxford, England). - : Oxford University Press (OUP). - 0268-1161 .- 1460-2350. ; 32:8, s. 1621-1630
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Tidskriftsartikel (refereegranskat)abstract
- Does an intensive weight reduction programme prior to IVF increase live birth rates for infertile obese women?An intensive weight reduction programme resulted in a large weight loss but did not substantially affect live birth rates in obese women scheduled for IVF.Among obese women, fertility and obstetric outcomes are influenced negatively with increased risk of miscarriage and a higher risk of maternal and neonatal complications. A recent large randomized controlled trial found no effect of lifestyle intervention on live birth in infertile obese women.A prospective, multicentre, randomized controlled trial was performed between 2010 and 2016 in the Nordic countries. In total, 962 women were assessed for eligibility and 317 women were randomized. Computerized randomization with concealed allocation was performed in the proportions 1:1 to one of two groups: weight reduction intervention followed by IVF-treatment or IVF-treatment only. One cycle per patient was included.Nine infertility clinics in Sweden, Denmark and Iceland participated. Women under 38 years of age planning IVF, and having a BMI ≥30 and <35 kg/m2 were randomized to two groups: an intervention group (160 patients) with weight reduction before IVF, starting with 12 weeks of a low calorie liquid formula diet (LCD) of 880 kcal/day and thereafter weight stabilization for 2-5 weeks, or a control group (157 patients) with IVF only.In the full analysis set (FAS), the live birth rate was 29.6% (45/152) in the weight reduction and IVF group and 27.5% (42/153) in the IVF only group. The difference was not statistically significant (difference 2.2%, 95% CI: 12.9 to -8.6, P = 0.77). The mean weight change was -9.44 (6.57) kg in the weight reduction and IVF group as compared to +1.19 (1.95) kg in the IVF only group, being highly significant (P < 0.0001). Significantly more live births were achieved through spontaneous pregnancies in the weight reduction and IVF group, 10.5% (16) as compared to the IVF only group 2.6% (4) (P = 0.009). Miscarriage rates and gonadotropin dose used for IVF stimulation did not differ between groups. Two subgroup analyses were performed. The first compared women with PCOS in the two randomized groups, and the second compared women in the weight reduction group reaching BMI ≤ 25 kg/m2 or reaching a weight loss of at least five BMI units to the IVF only group. No statistical differences in live birth rates between the groups in either subgroup analysis were found.The study was not powered to detect a small increase in live births due to weight reduction and was not blinded for the patients or physician. Further, the intervention group had a longer time to achieve a spontaneous pregnancy, but were therefore slightly older than the control group at IVF. The study only included women with a BMI lower than 35 kg/m2.The study suggests that weight loss for obese women (BMI: 30-34.9 kg/m2) may not rectify the outcome in IVF cycles, although a significant higher number of spontaneous conceptions occurred in the weight loss group. Also, the study suggests that intensive weight reduction with LCD treatment does not negatively affects the results.The study was funded by Sahlgrenska University Hospital (ALFGBG-70 940), Merck AB, Solna, Sweden (an affiliate of Merck KGaA, Darmstadt, Germany), Impolin AB, Hjalmar Svensson Foundation and Jane and Dan Olsson Foundation. Dr Thurin-Kjellberg reports grants from Merck, non-financial support from Impolin AB, during the conduct of the study, and personal fees from Merck outside the submitted work. Dr Friberg reports personal fees from Ferring, Merck, MSD, Finox and personal fees from Studentlitteratur, outside the submitted work. Dr Englund reports personal fees from Ferring, and non-financial support from Merck, outside the submitted work. Dr Bergh reports and has been reimbursed for: writing a newsletter twice a year (Ferring), lectures (Ferring, MSD, Merck), and Nordic working group meetings (Finox). Dr Karlström reports lectures (Ferring, Finox, Merck, MSD) and Nordic working group meetings (Ferring). Ms Kluge, Dr Einarsson, Dr Pinborg, Dr Klajnbard, Dr Stenlöf, Dr Larsson, Dr Loft and Dr Wistrand have nothing to disclose.ClinicalTrials.gov number, NCT01566929.23-03-2012.05-10-2010.
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| 6. |
- Evans-Hoeker, E, et al.
(författare)
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Dietary and/or physical activity interventions in women with overweight or obesity prior to fertility treatment: protocol for a systematic review and individual participant data meta-analysis
- 2022
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Ingår i: BMJ open. - : BMJ. - 2044-6055. ; 12:11
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Tidskriftsartikel (refereegranskat)abstract
- Dietary and/or physical activity interventions are often recommended for women with overweight or obesity as the first step prior to fertility treatment. However, randomised controlled trials (RCTs) so far have shown inconsistent results. Therefore, we propose this individual participant data meta-analysis (IPDMA) to evaluate the effectiveness and safety of dietary and/or physical activity interventions in women with infertility and overweight or obesity on reproductive, maternal and perinatal outcomes and to explore if there are subgroup(s) of women who benefit from each specific intervention or their combination (treatment-covariate interactions).We will include RCTs with dietary and/or physical activity interventions as core interventions prior to fertility treatment in women with infertility and overweight or obesity. The primary outcome will be live birth. We will search MEDLINE, Embase, Cochrane Central Register of Controlled Trials and trial registries to identify eligible studies. We will approach authors of eligible trials to contribute individual participant data (IPD). We will perform risk of bias assessments according to the Risk of Bias 2 tool and a random-effects IPDMA. We will then explore treatment-covariate interactions for important participant-level characteristics.Formal ethical approval for the project (Venus-IPD) was exempted by the medical ethics committee of the University Medical Center Groningen (METc code: 2021/563, date: 17 November 2021). Data transfer agreement will be obtained from each participating institute/hospital. Outcomes will be disseminated internationally through the collaborative group, conference presentations and peer-reviewed publication.CRD42021266201.
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| 7. |
- Ginström Ernstad, Erica, et al.
(författare)
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Preimplantation genetic testing and child health: a national register-based study
- 2023
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Ingår i: Human Reproduction. - : Oxford University Press (OUP). - 0268-1161 .- 1460-2350. ; 38:4, s. 739-750
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Tidskriftsartikel (refereegranskat)abstract
- STUDY QUESTION Is preimplantation genetic testing (PGT) associated with adverse perinatal outcome and early childhood health? SUMMARY ANSWER Children born after PGT had comparable perinatal outcomes to children born after IVF/ICSI and comparable findings regarding early childhood health. WHAT IS KNOWN ALREADY PGT is offered to couples affected by monogenic disorders (PGT-M) or inherited chromosomal aberrations (PGT-SR), limiting the risk of transferring the disorder to the offspring. PGT, an invasive technique, requires genetic analysis of one or up to ten cells from the embryo and is combined with IVF or ICSI. Several studies, most of them small, have shown comparable results after PGT and IVF/ICSI concerning perinatal outcome. Only a few studies with limited samples have been published on PGT and childhood health. STUDY DESIGN, SIZE, DURATION We performed a register-based study including all singletons born after PGT (n = 390) in Sweden during 1 January 1996-30 September 2019. Singletons born after PGT were compared with all singletons born after IVF/ICSI (n = 61 060) born during the same period of time and with a matched sample of singletons (n = 42 034) born after spontaneous conception selected from the Medical Birth Register. Perinatal outcomes, early childhood health, and maternal outcomes were compared between pregnancies after PGT and IVF/ICSI as well as between pregnancies after PGT and spontaneous conception. Primary outcomes were preterm birth (PTB) and low birthweight (LBW) whereas childhood morbidity was the secondary outcome. PARTICIPANTS/MATERIALS, SETTING, METHODS Data on women who went through PGT and gave birth were obtained from the local databases at the two PGT centres in Sweden, whereas data on IVF treatment for the IVF/ICSI group were obtained from the national IVF registers. These data were then cross-linked to national health registers; the Medical Birth Register, the Patient Register, and the Cause of Death Register. Logistic multivariable regression analysis and Cox proportional hazards models were performed with adjustment for relevant confounders. MAIN RESULTS AND THE ROLE OF CHANCE The mean follow-up time was 4.6 years for children born after PGT and 5.1 years for children born after spontaneous conception, whereas the mean follow-up time was 9.0 years for children born after IVF/ICSI. For perinatal outcomes, PTB occurred in 7.7% of children after PGT and in 7.3% of children after IVF/ICSI, whereas the rates were 4.9% and 5.2% for LBW (adjusted odds ratio (AOR) 1.22, 95% CI 0.82-1.81 and AOR 1.17, 95% CI 0.71-1.91, respectively). No differences were observed for birth defects. In comparison to spontaneous conception, children born after PGT had a higher risk for PTB (AOR 1.73, 95% CI 1.17-2.58). Regarding early childhood health, the absolute risk of asthma was 38/390 (9.7%) in children born after PGT and 6980/61 060 (11.4%) in children born after in IVF/ICSI, whereas the corresponding numbers were 34/390 (8.7%) and 7505/61 060 (12.3%) for allergic disorders. Following Cox proportional hazards models, no significant differences were found for these outcomes. Sepsis, hypothyroidism, attention deficit hyperactivity disorder, autism spectrum disorders, mental retardation, cerebral palsy, and epilepsy were diagnosed in a maximum of three PGT children. No PGT children died during the follow-up period. Regarding maternal outcomes, the rates of placenta praevia and caesarean delivery were significantly higher after PGT in comparison to spontaneous conception (AOR 6. 46, 95% CI 3.38-12.37 and AOR 1.52, 95% CI 1.20-1.92, respectively), whereas no differences were seen comparing pregnancies after PGT and IVF/ICSI. LIMITATIONS, REASONS FOR CAUTION The rather small sample size of children born after PGT made it impossible to adjust for all relevant confounders including fertilization method and culture duration. Moreover, the follow-up time was short for most of the children especially in the PGT group, probably lowering the absolute number of diagnoses in early childhood. WIDER IMPLICATIONS OF THE FINDINGS The results are reassuring and indicate that the embryo biopsy itself has no adverse effect on the perinatal, early childhood, or maternal outcomes. Although the results are comparable to IVF/ICSI also regarding early childhood outcome, they should be taken with caution due to the low number of children with diagnoses and short follow-up time. Long-term follow-up studies on children born after PGT are scarce and should be conducted considering the invasiveness of the technique. STUDY FUNDING/COMPETING INTEREST(S) The study was financed by grants from the Swedish state under the agreement between the Swedish government and the county councils, the ALF-agreement (LUA/ALF 70940), the Board of National Specialised Medical Care at Sahlgrenska University Hospital and Hjalmar Svensson Research Foundation. There are no conflicts of interest to declare.
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| 8. |
- Isaksson, Stina, et al.
(författare)
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Two decades after legislation on identifiable donors in Sweden: are recipient couples ready to be open about using gamete donation?
- 2011
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Ingår i: Human reproduction (Oxford, England). - : Oxford University Press (OUP). - 1460-2350 .- 0268-1161. ; 26:4, s. 853-60
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND Two decades after the introduction of Swedish legislation that allows children born as a result of gamete donation access to identifying information about the donor, a nationwide multicentre study on the psychosocial consequences of this legislation for recipients and donors of gametes was initiated in 2005. The aim of the present study was to investigate recipient couples' attitudes and behaviour regarding disclosure to offspring and others, attitudes towards genetic parenthood and perceptions of information regarding parenthood after donation. METHODS The present study is part of the prospective longitudinal 'Swedish study on gamete donation', including all fertility clinics performing donation treatment in Sweden. A consecutive cohort of 152 heterosexual recipient couples of donated oocytes (72% response) and 127 heterosexual recipient couples of donated sperm (81% response) accepted participation in the study. In connection with the donation treatment, male and female participants individually completed two questionnaires with study-specific instruments concerning disclosure, genetic parenthood and informational aspects. RESULTS About 90% of participants (in couples receiving anonymous donated gametes) supported disclosure and openness to the offspring concerning his/her genetic origin. Only 6% of all participants had not told other people about their donation treatment. Between 26 and 40% of participants wanted additional information/support about parenthood following donation treatment. CONCLUSIONS Two decades after the Swedish legislation of identifiable gamete donors, recipient couples of anonymously donated sperm and oocytes are relatively open about their treatment and support disclosure to offspring. Recipient couples may benefit from more information and support regarding parenthood after gamete donation. Further studies are required to follow-up on the future parents' actual disclosure behaviour directed to offspring.
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| 9. |
- Järvholm, Stina, et al.
(författare)
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Experiences of Pre-Implantation Genetic Diagnosis (PGD) in Sweden: a Three-Year Follow-Up of Men and Women.
- 2017
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Ingår i: Journal of genetic counseling. - : Wiley. - 1573-3599 .- 1059-7700. ; 26:5, s. 1008-1016
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Tidskriftsartikel (refereegranskat)abstract
- Men and women with a hereditary genetic disease are faced with different options when they wish to become parents. One is pre-implantation genetic diagnosis (PGD) which is a combination of in vitro fertilization (IVF) and genetic analysis of the embryo before implantation. The present study focused on men and women's psychological experiences of PGD three years after applying for PGD. Nineteen women and seventeen men (i.e. seventeen couples and two women) participated. The interviews were analysed by thematic method. It is better to have tried was identified as a master theme, under which came three underlying sub-themes, which had the following headings: Practical experience of PGD, Psychological experience of PGD and Goals of PGD. The results show that men and women three years after PGD are still psychologically affected by their experience. The men and women raised concerns that their relationship had been affected, both positively and negatively, and feelings of anxiety and depression still remained. Healthcare services should recognize the heterogeneous nature of the group being studied and therefore the need for counselling can arise at different times and in relation to different areas, regardless of the outcome of the PGD.
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| 10. |
- Järvholm, Stina, et al.
(författare)
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INFLUENCE OF FERTILITY ON FAMILY PLANNING DECISIONS AMONG MIDDLEAGED SURVIVORS OF CHILDHOOD CANCER: A QUALITATIVE STUDY
- 2020
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Ingår i: Journal of Cancer Rehabilitation (EDISCIENCES). - 2704-6494. ; 3, s. 5-13
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Tidskriftsartikel (refereegranskat)abstract
- Background As the number of childhood cancer survivors increases, there is a need to affront associated issues in adulthood such as anxiety, depression, and infertility. The aim of this qualitative study was to examine how childhood cancer survivors at the end of their fertile period were informed about fertility earlier in life and to investigate how this information influenced family planning decisions during adulthood. Methods The study included childhood cancer survivors in western Sweden ages 37–45 years identified from the Childhood Cancer Registry. Ten women and eight men ultimately participated in the study. Participants had been treated for cancer at a median age of 14 years (range, 2.5–17.5 years) and the median time since diagnosis was 26.0 years (range, 21.0–44.5 years). The study design consisted of a semi-structured interview and thematic analysis. Results A master theme that emerged from interviews was A long and uncertain road, which was divided into three underlying subthemes: Pictures of fertility e.g., from healthcare providers or parents; Experience of fertility e.g., searching as an adult, feeling like everyone else, not for me; and Emotions and fertility e.g., better not to think about it, cancer will affect my child. Women scored consistently lower than men on questionnaires regarding quality of life. Conclusion Most participants felt that they received insufficient information about fertility after cancer. The present study also highlighted a lack of support for cancer survivors into adulthood, which affected their psychological well-being and their inclination to become parents themselves.
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