Dataset Information

ICSI Versus Conventional IVF in Women Aged 40 Years or More and Unexplained Infertility: A Retrospective Evaluation of 685 Cycles with Propensity Score Model.

ABSTRACT: This study compared the cumulative live birth rates following Intracytoplasmic sperm injection (ICSI) versus conventional in vitro fertilization (cIVF) in women aged 40 years or more and unexplained infertility. A cohort of 685 women undergoing either autologous conventional IVF or ICSI was retrospectively analyzed. The effects of conventional IVF or ICSI procedure on cumulative pregnancy and live birth rates were evaluated in univariate and in multivariable analysis. In order to reduce potential differences between women undergoing either IVF or ICSI and to obtain unbiased estimation of the treatment effect, propensity score was estimated. ICSI was performed in 307 couples (ICSI group), whereas cIVF was performed in 297 couples (cIVF group), resulting in 45 and 43 live deliveries, respectively. No differences were observed in morphological embryo quality, in the number of cleavage stage embryos, in the number of transferred embryos, and in the number of vitrified embryos. As for the clinical outcome, no differences were observed in pregnancy rate, cumulative pregnancy rate, live birth rate, cumulative live birth rate, and abortion rate. The present results suggest that ICSI is not associated with increased likelihood of a live birth for unexplained, non-male factor infertility, in women aged 40 years or more.

SUBMITTER: Gennarelli G

PROVIDER: S-EPMC6833057 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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ICSI Versus Conventional IVF in Women Aged 40 Years or More and Unexplained Infertility: A Retrospective Evaluation of 685 Cycles with Propensity Score Model.

Gennarelli Gianluca G Carosso Andrea A Canosa Stefano S Filippini Claudia C Cesarano Sara S Scarafia Carlotta C Brunod Nicole N Revelli Alberto A Benedetto Chiara C

Journal of clinical medicine 20191016 10

This study compared the cumulative live birth rates following Intracytoplasmic sperm injection (ICSI) versus conventional in vitro fertilization (cIVF) in women aged 40 years or more and unexplained infertility. A cohort of 685 women undergoing either autologous conventional IVF or ICSI was retrospectively analyzed. The effects of conventional IVF or ICSI procedure on cumulative pregnancy and live birth rates were evaluated in univariate and in multivariable analysis. In order to reduce potentia ...[more]

PMID: 31623077

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Project description:INTRODUCTION:Intracytoplasmic sperm injection (ICSI), originally introduced as add-on to in vitro fertilisation (IVF) for couples with severe male infertility, is in current clinical practice also used in couples with mild male or even unexplained infertility. However, ICSI has involved unresolved concerns regarding the selection and damage to gametes and the health conditions of the offspring, and it is also labour intensive and therefore more expensive than conventional IVF. High-quality well-powered randomised clinical trials (RCTs) comparing ICSI and IVF are lacking. METHODS AND ANALYSIS:We propose a multicentre, open-label RCT in 10 reproductive medical centres across China. We will study couples with non-severe male infertility (defined as a semen concentrate 5-15×106/mL or sperm with a progressive motility 10%-32%) scheduled for their first or second ICSI or IVF cycle, as low fertility rate after fertilisation are more frequent in this population, which could lead to controversy about ICSI or conventional IVF for fertilisation. On the day of oocyte retrieval, eligible participants are after informed consent be randomised to undergo either ICSI or conventional IVF in a 1:1 treatment ratio. Other standard assisted reproductive treatments are similar and parallel between two groups. Our primary outcome is ongoing pregnancy leading to live birth after the first cycle with embryo transfer. To demonstrate or refute a difference of 7% between ICSI and conventional IVF, we need to include 2346 women (1173 in each intervention arm). In addition, we will follow-up neonatal outcomes after delivery to identify the influence of ICSI on offspring. ETHICS AND DISSEMINATION:Ethical approval was obtained from Peking University Third Hospital medical science research ethics committee. The findings will be disseminated to the public through conference presentations and peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov registry (NCT03298633).

Project description:Study questions:Does ICSI result in a higher live birth rate as compared with conventional IVF in couples with non-male factor infertility? What is known already:ICSI is primarily indicated for severe male factor infertility. While the use of ICSI for couples with non-male factor infertility has been increasing worldwide, this is not supported by data from randomised controlled trials. Evidence from non-randomised studies suggest no benefit from ICSI compared with conventional IVF in non-male factor infertility, if not a harm. Study design size duration:This randomised, open-label, multi-centre trial aims to compare the effectiveness of one ICSI cycle and one conventional IVF cycle in infertile couples with non-male factor infertility. A total of 1064 couples will be randomly allocated to an ICSI group and a conventional IVF group. The estimated duration of the study is 30 months. Participants/materials setting methods:Eligible couples are those whose husbands' total sperm count and motility are normal, have undergone ?2 previous IVF/ICSI attempts, use antagonist protocol for ovarian stimulation, agree to have ?2 embryos transferred and are not participating in another IVF study at the same time. Women undergoing IVM cycles, using frozen semen or having a poor fertilisation (?25%) in previous cycle will not be eligible. Couples will be randomised to undergo ICSI or conventional IVF (1:1) with ongoing pregnancy resulting in live birth after the first embryo transfer of the started treatment cycle as the primary endpoint. All analyses will be conducted on an intention-to-treat basis. Effect sizes will be summarised as relative risk (RR), with precision evaluated by 95% CIs. STUDY FUNDING/COMPETING INTERESTS:All authors declare having no conflict of interests with regards to this trial. This work was supported by a grant from MSD [MISP #57508]. Trial registration number:NCT03428919. Trial registration date:8 February 2018. DATE OF FIRST PATIENT’S ENROLMENT:16 March 2018.

Project description:BackgroundUnexplained infertility accounts for 25% of infertility causes in the UK. Active intervention methods, such as intrauterine insemination (IUI) or in vitro fertilisation (IVF), are often sought. Despite the National Institute for Health and Care Excellence (NICE) recommending IVF for unexplained infertility, this recommendation has generated an ongoing debate, with few fertility clinics discontinuing the use of IUI as the first-line management of choice. In contrast to NICE, recent guidance released from the European Society for Human Reproduction and Embryology (ESHRE) in August 2023 supports the use of IUI as first-line. High-quality evidence behind such interventions is lacking, with current literature providing conflicting results.AimsThis review aims to provide a literature overview exploring whether IUI or IVF should be used as first-line treatment for couples with unexplained infertility, in the context of current guidelines.MethodsThe primary outcome used to assess efficacy of both treatment methods is live birth (LB) rates. Secondary outcomes used are clinical pregnancy (CP) and ongoing pregnancy (OP) rates. A comprehensive literature search of 4 databases: Ovid MEDLINE, EMBASE, Maternity & Infant Care and the Cochrane Library were searched in January 2022. Upon removal of duplications, abstract screening, and full-text screening, a total of 34 papers were selected.Discussion/conclusionThis review highlights a large discrepancy in the literature when examining pregnancy outcomes of IUI and IVF treatments. Evidence shows IUI increases LB and CP rates 3-fold compared to expectant management. Literature comparing IUI to IVF is less certain. The review finds the literature implies IVF should be used for first-line management but the paucity of high-quality randomised controlled trials (RCTs), coupled with heterogeneity of the identified studies and a lack of research amongst women > 40 years warrants the need for further large RCTs. The decision to offer IUI with ovarian stimulation (IUI-OS) or IVF should be based upon patient prognostic factors. We suggest that IUI-OS could be offered as first-line treatment for unexplained infertility for women < 38 years, with good prognosis, and IVF could be offered first to those > 38 years. Patients should be appropriately counselled to enable informed decision making.

Project description:Study questionDoes the duration of embryo exposure to hyaluronic acid (HA) enriched medium improve the rate of live birth events (LBEs)?Summary answerThe use of embryo transfer (ET) medium rich in HA improves LBE (a singleton or twin live birth) regardless of the duration of exposure evaluated in this study, but does not alter gestation or birthweight (BW).What is known alreadyHA-enriched medium is routinely used for ET in ART to facilitate implantation, despite inconclusive evidence on safety and efficacy.Study design size durationA cohort study was performed evaluating clinical treatment outcomes before and after HA-enriched ET medium was introduced into routine clinical practice. In total, 3391 fresh ET procedures were performed using low HA and HA-rich medium in women undergoing publicly funded IVF/ICSI treatment cycles between May 2011 and April 2015 were included in this cohort study.Participants/materials setting methodsA total of 1018 ET performed using low HA medium were compared with 1198, and 1175 ET following exposure to HA-rich medium for 2-4 h (long HA exposure) or for 10-30 min (short HA exposure), respectively. A multiple logistic regression analysis was used to compare clinical outcomes including BW, gestational age and sex ratios between groups, whilst adjusting for patient age, previous attempt, incubator type and the number of embryos transferred.Main results and the role of chanceThe use of HA-rich medium for ET was positively and significantly associated with improved clinical pregnancy rate and LBE, for both exposure durations: long HA (odds ratio (OR) = 1.21, 95% CI: 0.99-1.48), short HA (OR = 1.32, 95% CI: 1.02-1.72) and pooled OR = 1.26, 95% CI: 1.03-1.54, relative to the use of low HA medium. A comparative analysis of the risks of early pregnancy loss following long HA exposure (OR = 0.76, 95% CI: 0.54-1.06), short HA exposure (OR = 0.84, 95% CI: 0.54-1.30) and late miscarriage (OR = 0.88, 95% CI: 0.51-1.53) (OR = 1.41, 95% CI 0.72-2.77), were lower and not statistically significant. Similarly, ordinary regression analysis of the differences in BW at both HA exposures; pooled OR = -0.9 (-117.1 to 115.3), and adjusted BW between both HA cohorts; pooled OR = -13.8 (-106.1 to 78.6) did not show any differences. However, a difference in gestational age (pooled OR -0.3 (-3.4 to 2.9)) and sex ratio (pooled OR 1.43 (0.95-2.15)) were observed but these were not statistically significant relative to low HA medium.Limitations reasons for cautionThe strength of a randomized treatment allocation was not available in this evaluation study, therefore effects of unmeasured or unknown confounding variables cannot be ruled out.Wider implications of the findingsThe result of this large cohort study strengthens the case for using HA-rich medium routinely at transfer, while adding the important clinical information that duration of exposure may not be critical. The composition and effects of commercial IVF culture media on success rate and safety remains a major controversy despite increasing calls for transparency and evidence-based practice in ART. Nonetheless, the lack of differences in BW and gestational age observed in this study were reassuring. However, an appraisal of clinical outcomes and appropriate research investigations are required for the continuous evaluation of efficacy and safety of HA.Study funding/competing interestsT.A. is funded by a Clinical Doctoral Research Fellowship (CDRF) grant (reference: ICA-CDRF-2015-01-068) from the National Institute for Health Research (NIHR). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health. The authors declare no conflict of interest.

Dataset Information

ICSI Versus Conventional IVF in Women Aged 40 Years or More and Unexplained Infertility: A Retrospective Evaluation of 685 Cycles with Propensity Score Model.

Publications

ICSI Versus Conventional IVF in Women Aged 40 Years or More and Unexplained Infertility: A Retrospective Evaluation of 685 Cycles with Propensity Score Model.

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