Impact of first-trimester anomaly scan on health-related quality of life and healthcare costs: a scoping review.

IMPORTANCE: The first-trimester anomaly scan (FTAS) has the potential to detect major congenital anomalies in an early stage of pregnancy. Due to this potential early detection, there is a trend to introduce FTAS in regular care. Data regarding the impact of FTAS on the patient's perspective are limited. OBJECTIVE: To provide an overview of the literature assessing the impact of the FTAS on health-related quality of life (HRQoL) and healthcare costs. EVIDENCE ACQUISITION: Literature search was performed in Embase, PubMed, Medline Ovid, Cochrane Library database, Web-of-Science, and Google Scholar were searched. All studies that reported the performance of a nuchal translucency measurement with a basic fetal assessment HRQoL or healthcare costs of FTAS were included. Studies solely describing screening of chromosomal anomalies were excluded. Three authors independently screened the studies and extracted the data. Results were combined using descriptive analysis. PROSPERO registration number: CRD42016045190. RESULTS: The search yielded 3242 articles and 16 were included. Thirteen articles (7045 pregnancies) examined the relationship between FTAS and HRQoL. Anxiety scores were raised temporarily before FTAS and returned to early pregnancy baseline following the absence of anomalies. Depression scores did not change significantly as a result of FTAS. Three articles studied healthcare costs. These studies, published before 2005, found a combination of FTAS and second-trimester anomaly scan (STAS) resulted in an increased amount of detected anomalies when compared to a STAS-only regimen. However, the combination would also be more costly. CONCLUSIONS: Women experience anxiety in anticipation of the FTAS result and following a reassuring FTAS result, anxiety returns to the baseline level. FTAS seems to be a reassuring experience. The included studies on costs showed the addition of FTAS is likely to increase the number of detected anomalies against an increase in healthcare costs per pregnancy.Review registration: PROSPERO CRD42016045190.

Home-based monitoring of ovulation to time frozen embryo transfers in the Netherlands (Antarctica-2): an open-label, nationwide, randomised, non-inferiority trial.

BACKGROUND: The growing field of assisted reproductive techniques, including frozen-thawed embryo transfer (FET), should lead the way to the best sustainable health care without compromising pregnancy chances. Correct timing of FET is crucial to allow implantation of the thawed embryo. Nowadays, timing based on hospital-controlled monitoring of ovulation in the natural cycle of a woman is the preferred strategy because of the assumption of favourable fertility prospects. However, home-based monitoring is a simple method to prevent patient travel and any associated environmental concerns. We compared ongoing pregnancy rates after home-based monitoring versus hospital-controlled monitoring with ovulation triggering. METHODS: This open-label, multicentre, randomised, non-inferiority trial was undertaken in 23 hospitals and clinics in the Netherlands. Women aged between 18 and 44 years with a regular ovulatory menstrual cycle were randomly assigned in a 1:1 ratio via a web-based randomisation program to home-based monitoring or hospital-controlled monitoring. Those who analysed the data were masked to the groups; those collecting the data were not. All endpoints were analysed by intention to treat and per protocol. Non-inferiority was established when the lower limit of the 90% CI exceeded -4%. This study was registered at the Dutch Trial Register (Trial NL6414). FINDINGS: 1464 women were randomly assigned between April 10, 2018, and April 13, 2022, with 732 allocated to home-based monitoring and 732 to hospital-controlled monitoring. Ongoing pregnancy occurred in 152 (20·8%) of 732 in the home-based monitoring group and in 153 (20·9%) of 732 in the hospital-controlled monitoring group (risk ratio [RR] 0·99 [90% CI 0·81 to 1·22]; risk difference [RD] -0·14 [90% CI -3·63 to 3·36]). The per-protocol analysis confirmed non-inferiority (152 [21·0%] of 725 vs 153 [21·0%] of 727; RR 1·00 (90% CI 0·81 to 1·23); RD -0·08 [90% CI -3·60 to 3·44]). INTERPRETATION: Home-based monitoring of ovulation is non-inferior to hospital-controlled monitoring of ovulation to time FET. FUNDING: The Dutch Organisation for Health Research and Development.

Cost-effectiveness of single versus double embryo transfer in IVF in relation to female age.

OBJECTIVE: To evaluate the cost-effectiveness of single embryo transfer followed by an additional frozen-thawed single embryo transfer, if more embryos are available, as compared to double embryo transfer in relation to female age. STUDY DESIGN: We used a decision tree model to evaluate the costs from a healthcare provider perspective and the pregnancy rates of two embryo transfer policies: one fresh single embryo transfer followed by an additional frozen-thawed single embryo transfer, if more embryos are available (strategy I), and double embryo transfer (strategy II). The analysis was performed on an intention-to-treat basis. Sensitivity analyses were carried out to evaluate the robustness of our model and to identify which model parameters had the strongest impact on the results. RESULTS: SET followed by an additional frozen-thawed single embryo transfer if available was dominant, less costly and more effective, over DET in women under 32 years. In women aged 32 or older DET was more effective than SET followed by an additional frozen-thawed single embryo transfer if available but also more costly. CONCLUSION: SET followed by an additional frozen-thawed single embryo transfer should be the preferred strategy in women under 32 undergoing IVF. The choice for SET followed by an additional frozen-thawed single embryo transfer or DET in women aged 32 or older depends on individual patient preferences and on how much society is willing to pay for an extra child. There is a strong need for a randomized clinical trial comparing the cost and effects of SET followed by an additional frozen-thawed single embryo transfer and DET in the latter category of women.

Cost-effectiveness of assisted conception for male subfertility.

Intrauterine insemination (IUI), with or without ovarian stimulation, IVF and intracytoplasmatic sperm injection (ICSI) are frequently used treatments for couples with male subfertility. No consensus has been reached on specific cut-off values for semen parameters, at which IVF would be advocated over IUI and ICSI over IVF. The aim of this study was to evaluate the cost-effectiveness of interventions for male subfertility according to total motile sperm count (TMSC). A computer-simulated cohort of subfertile women aged 30 years with a partner was analysed with a pre-wash TMSC of 0 to 10 million. Three treatments were evaluated: IUI with and without controlled ovarian stimulation; IVF; and ICSI. Main outcome was expected live birth; secondary outcomes were cost per couple and the incremental cost-effectiveness ratio. The choice of IVF over IUI with ovarian stimulation and ICSI over IVF depends on the willingness to pay for an extra live birth. If only cost per live birth is considered for each treatment, above a pre-wash TMSC of 3 million, IUI is less costly than IVF and, below a pre-wash, TMSC of 3 million ICSI is less costly. Effectiveness needs to be confirmed in a large randomized controlled trial.

Cost-effectiveness of treatment strategies in women with PCOS who do not conceive after six cycles of clomiphene citrate.

This study evaluated the cost-effectiveness of treatments for women with polycystic ovary syndrome (PCOS) who ovulate on clomiphene citrate but do not conceive after six cycles. A decision-analytic framework was developed for six scenarios: (1) three cycles of IVF; (2) continuation of clomiphene citrate for six cycles, followed by three cycles of IVF in case of no birth; (3) six cycles of gonadotrophins and three cycles of IVF; (4) 12 cycles of gonadotrophins and three cycles of IVF; (5) continuation of clomiphene citrate for six cycles, six cycles of gonadotrophins and three cycles of IVF; (6) continuation of clomiphene citrate for six cycles, 12 cycles of gonadotrophins and three cycles of IVF. Two-year cumulative birth rates were 58%, 74%, 89%, 97%, 93% and 98% and costs per couple were € 9518, € 7530, € 9711, € 9764, € 7651 and € 7684 for scenarios 1-6, respectively. Scenario 2 was the lowest cost option. The extra cost for at least one live birth in scenario 5 was € 629 and in scenario 6 € 630. In these subjects, continuation of treatment for six cycles of clomiphene citrate, 6 or 12 cycles of gonadotrophins and IVF is potentially cost-effective. These results should be confirmed in a randomized clinical trial.

Long term outcome in subfertile couples with isolated cervical factor.

OBJECTIVE: A previous randomized clinical trial (RCT) compared immediate treatment with intrauterine insemination (IUI) to expectant management for six months in subfertile couples with an isolated cervical factor. That study showed higher ongoing pregnancy rates in couples receiving intrauterine insemination. The current study compared the long-term effectiveness and costs of this intervention. STUDY DESIGN: We followed all couples (N=99) who were previously included in the RCT for three years after randomization and registered pregnancies and treatments. After the initial trial period, couples in both groups were offered further treatment according to local protocol. The primary outcome was an ongoing pregnancy after three years. RESULTS: After three years, there were 36 ongoing pregnancies in the immediate IUI group (N=51 couples) and 38 ongoing pregnancies in the expectant management group (N=48 couples). The ongoing pregnancy rates were 71% and 79% respectively (RR 0.89 (95% confidence interval (CI) 0.7-1.1)). CONCLUSIONS: In couples with an isolated cervical factor, a treatment strategy including immediate treatment with IUI does not result in higher ongoing pregnancy rates on the long term. Initial expectant management is therefore justified in these couples and identifying a cervical factor by a post-coital test is unnecessary.

High live birth rate in the subsequent IVF cycle after first-cycle poor response among women with mean age 35 and normal FSH.

Poor ovarian response in IVF cycles is associated with diminished ovarian reserve and poor pregnancy outcome. Little is known about pregnancy outcome after a poor response in women with a normal ovarian reserve. This retrospective study studied women undergoing IVF/intracytoplasmic sperm injection between January 2003 to December 2008 in the FertilityPLUS Clinic in Auckland, New Zealand. All women with a poor response in the first cycle were selected. Primary outcome was live birth after the second cycle. Secondary outcomes were poor response in the second cycle and the predictive values of female age and basal FSH at first cycle and IVF outcome at second cycle. Of the 2487 women starting IVF, 142 women (5.7%) with a poor response in the first cycle were selected, of which 66 (46.5%) women had a repeated poor response in the second cycle. There were 31 live births in the second cycle (21.8%). Female age was the only significant predictor for repeated poor response (AUC 0.69, 95% CI 0.61-0.78) and clinical pregnancy (AUC 0.66, 95% CI 0.57-0.75), but the predictive value was low. Therefore poor response in women with a normal ovarian reserve should not be a reason to discontinue further IVF treatment. Poor ovarian response in IVF cycles is associated with diminished ovarian reserve and poor pregnancy outcome. Little is known about pregnancy outcome after a poor response in women with a normal ovarian reserve. In this retrospective study, we studied women undergoing IVF/intracytoplasmic sperm injection (ICSI) between January 2003 to December 2008 in the FertilityPLUS Clinic in Auckland, New Zealand. All women with a poor response in the first cycle were selected. Primary outcome was live birth after the second cycle. Secondary outcomes were poor response in the second cycle and the predictive value of female age and basal FSH at first cycle and IVF outcome at the second cycle. Of the 2487 women starting wit IVF, a total of 142 women (5.7%) with a poor response in the first cycle were selected, of which 66 (46.5%) women had a repeated poor response in the second cycle. There were 31 live births in the second cycle (22%). Female age was the only significant predictor for repeated poor response and clinical pregnancy, but the predictive value was low. Therefore poor response in women with a normal ovarian reserve should not be a reason to discontinue further IVF treatment.

Epidural analgesia versus patient-controlled analgesia for pain relief in uterine artery embolization for uterine fibroids: a decision analysis.

PURPOSE: This study was designed to compare the costs and effects of epidural analgesia (EDA) to those of patient-controlled intravenous analgesia (PCA) for postintervention pain relief in women having uterine artery embolization (UAE) for systematic uterine fibroids. METHODS: Cost-effectiveness analysis (CEA) based on data from the literature by constructing a decision tree to model the clinical pathways for estimating the effects and costs of treatment with EDA and PCA. Literature on EDA for pain-relief after UAE was missing, and therefore, data on EDA for abdominal surgery were used. Outcome measures were compared costs to reduce one point in visual analogue score (VAS) or numeric rating scale (NRS) for pain 6 and 24 h after UAE and risk for complications. RESULTS: Six hours after the intervention, the VAS was 3.56 when using PCA and 2.0 when using EDA. The costs for pain relief in women undergoing UAE with PCA and EDA were 191 and 355, respectively. The costs for EDA to reduce the VAS score 6 h after the intervention with one point compared with PCA were 105 and 179 after 24 h. The risk of having a complication was 2.45 times higher when using EDA. CONCLUSIONS: The results of this indirect comparison of EDA for abdominal surgery with PCA for UAE show that EDA would provide superior analgesia for post UAE pain at 6 and 24 h but with higher costs and an increased risk of complications.

Economic evaluation studies in reproductive medicine: a systematic review of methodologic quality.

OBJECTIVE: To evaluate the methodologic quality of economic analyses published in the field of reproductive medicine. DESIGN: Systematic review. SETTING: Centers for reproductive care. PATIENT(S): Infertility patients. INTERVENTION(S): We performed a Medline search to identify economic evaluation studies in reproductive medicine. We included studies that concerned interventions, evaluated costs and effects, and were published in a journal on reproductive medicine, gynecology, or a major general journal from 1997 through May 2011. MAIN OUTCOME MEASURE(S): Number of quality criteria adhered to. RESULT(S): Our search revealed 5,519 articles, of which 85 met our inclusion criteria. Seventy-seven (91%) of the economic analyses were on treatment, six (7%) on diagnosis, and two (2%) on screening. The mean number of quality criteria adhered to was 20 out of 30 items, and only one article met all 30 criteria. The mean number of criteria adhered to was higher if at least one of the authors was from a methodologic or health economics department (mean 23 [n = 30] versus mean 20 [n = 55]). The most common limitations of published economic evaluation studies were in methodology or presentation of incremental analyses, sensitivity analyses, and discounting. CONCLUSION(S): Economic analyses published in the past 15 years in the field of reproductive medicine seldom adhere to all recommended methodologic standards. A large majority of these publications evaluated treatments rather than diagnostic interventions.

Cost effectiveness of ovarian reserve testing in in vitro fertilization: a Markov decision-analytic model.

OBJECTIVE: To compare the cost effectiveness of ovarian reserve testing in in vitro fertilization (IVF). DESIGN: A Markov decision model based on data from the literature and original patient data. SETTING: Decision analytic framework. PATIENT(S): Computer-simulated cohort of subfertile women aged 20 to 45 years who are eligible for IVF. INTERVENTION(S): [1] No treatment, [2] up to three cycles of IVF limited to women under 41 years and no ovarian reserve testing, [3] up to three cycles of IVF with dose individualization of gonadotropins according to ovarian reserve, and [4] up to three cycles of IVF with ovarian reserve testing and exclusion of expected poor responders after the first cycle, with no treatment scenario as the reference scenario. MAIN OUTCOME MEASURE(S): Cumulative live birth over 1 year, total costs, and incremental cost-effectiveness ratios. RESULT(S): The cumulative live birth was 9.0% in the no treatment scenario, 54.8% for scenario 2, 70.6% for scenario 3 and 51.9% for scenario 4. Absolute costs per woman for these scenarios were €0, €6,917, €6,678, and €5,892 for scenarios 1, 2, 3, and 4, respectively. Incremental cost-effectiveness ratios (ICER) for scenarios 2, 3, and 4 were €15,166, €10,837, and €13,743 per additional live birth. Sensitivity analysis showed the model to be robust over a wide range of values. CONCLUSION(S): Individualization of the follicle-stimulating hormone dose according to ovarian reserve is likely to be cost effective in women who are eligible for IVF, but this effectiveness needs to be confirmed in randomized clinical trials.

Unintended pregnancies after Essure sterilization in the Netherlands.

OBJECTIVE: To analyze the data of cases of unintended pregnancies after Essure sterilization. DESIGN: Retrospective case series analysis. SETTING: National multicenter. PATIENT(S): Ten cases of unintended pregnancies after Essure sterilization in the Netherlands were reported from August 2002 through May 2008. INTERVENTION(S): Data on the hysteroscopic Essure sterilization procedures and postprocedure confirmation tests of the reported cases were reviewed and analyzed by two authors. The causes of the unintended pregnancies were determined in agreement with the physicians who performed the sterilizations. MAIN OUTCOME MEASURE(S): Most pregnancies occurred in patients with only one device placement and bilateral occlusion on hysterosalpingography (HSG). Other cases included misinterpretation of HSG, undetected abnormal device position by ultrasound, one undetected preprocedure pregnancy, and two patient failures to follow up with the physician advice. CONCLUSION(S): The risk of pregnancy after hysteroscopic sterilization may be reduced by strictly following the follow-up protocol, performing a urinary pregnancy test on the day of the procedure, and instructing the patient to return for the follow-up visit. A procedure with only a single device placement in a patient without a history of tubectomy of the heterolateral tube should be considered unsuccessful.