Dataset Information

ALADDIN study: does assisted hatching of vitrified/warmed blastocysts improve live birth rate? Protocol for a multicentric randomised controlled trial.

ABSTRACT: INTRODUCTION:Recent data suggest a higher clinical pregnancy rate performing assisted hatching (AH) on previously cryopreserved embryos but fail to demonstrate significant effects on live birth rate. However, current evidence is based on studies with a small sample size and may hide a type II error. Moreover, poor attention has been given to the specific effect of AH on frozen/thawed blastocysts. To shed light on this topic, we developed the present protocol for a randomised trial to investigate the benefits of the laser-mediated partial removal of the zona pellucida in vitrified/warmed blastocysts. METHODS AND ANALYSIS:The pArtiaL zonA pelluciDa removal by assisteD hatchINg of blastocysts (ALADDIN) study is a multicentric prospective comparative study with a parallel randomised controlled design aiming to investigate whether AH performed on warmed blastocysts before embryo transfer can improve live birth rate. Women allocated to the control group will undergo embryo transfer of blastocysts not previously subjected to AH. Two infertility units will be involved in the study. Enrolment of patients will last 18 months with quarterly monitoring and the entire study is foreseen to be closed in 36 months. Secondary outcomes include: proportion of transferred blastocysts/thawed blastocyst, morphological features of blastocysts before embryo transfer, implantation, biochemical pregnancy, clinical pregnancy (ultrasound visible gestational sac), miscarriage, multiple pregnancy, preterm birth (<37 weeks of gestation), obstetrical and neonatal complications and congenital anomaly rates. ETHICS AND DISSEMINATION:This protocol received a favourable ethical opinion from the Ethical Committee of IRCCS San Raffaele Scientific Institute and the Ethical Committee Area 2 Milan. Each participant will provide written consent to participate and remain encoded during the study. The trial results will be published in peer-reviewed journals and presented at conferences. TRIAL REGISTRATION NUMBER:NCT03623659; Pre-results.

SUBMITTER: Alteri A

PROVIDER: S-EPMC7371140 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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ALADDIN study: does assisted hatching of vitrified/warmed blastocysts improve live birth rate? Protocol for a multicentric randomised controlled trial.

Alteri Alessandra A Guarneri Cristina C Corti Laura L Restelli Liliana L Reschini Marco M Giardina Paolo P Papaleo Enrico E Somigliana Edgardo E Viganò Paola P Paffoni Alessio A

BMJ open 20200719 7

<h4>Introduction</h4>Recent data suggest a higher clinical pregnancy rate performing assisted hatching (AH) on previously cryopreserved embryos but fail to demonstrate significant effects on live birth rate. However, current evidence is based on studies with a small sample size and may hide a type II error. Moreover, poor attention has been given to the specific effect of AH on frozen/thawed blastocysts. To shed light on this topic, we developed the present protocol for a randomised trial to inv ...[more]

PMID: 32690492

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Project description:Backgrounds: Growth hormone (GH) was used for many years to increase ovarian response in poor ovarian responders (PORs). Although meta-analysis suggested that GH therapy improve early clinical outcomes, the benefit of GH usage on chance of live birth was still widely debated. This study was to determine whether or not GH supplementation influences the live birth rate (LBR). Methods: A total of 3,080 expected PORs receiving and not receiving (control) GH adjuvant therapy at Peking University Third Hospital from January 2017 to March 2018 were retrospectively analyzed. The basal characteristics of patients were compared using analysis of variance (continuous variables) and categorical variables were evaluated with a chi-square test. Logistic regression analyses were used to evaluate potential associations of LBR with GH treatment while adjusting other confounding factors. Results: No statistically significant differences existed in miscarriage rate (5.3 vs. 12.5%; p = 0.076) and LBR (37.7 vs. 34.5%; p = 0.426) in young expected PORs (< 35 years of age). Moreover, no significant differences existed in the miscarriage rate (25.6 vs. 23.3%; p = 0.681), and LBR (17.8 vs. 17.9%; p = 0.977) in the old expected PORs (≥35 years of age). Logistic regression suggested that GH adjuvant therapy did not improve the LBR in young (OR, 1.27; 95% CI, 0.88-1.85; p = 0.203) and elderly expected PORs (OR, 1.20; 95% CI, 0.82-1.76; p = 0.342), while GH was not associated with risk of miscarriage in young (OR, 0.37; 95% CI, 0.11-1.24; p = 0.108) and elderly expected PORs (OR, 0.91; 95% CI, 0.43-1.93; p = 0.813). In subgroup analysis, GH treatment significantly increased the day 3 embryos available rate in the subgroup of young PORs with the long down-regulation (63.11 vs. 49.35%; p = 0.004), while significantly reduced the risk of miscarriage in the subgroup of young PORs with GnRH antagonist protocol (0.00 vs. 12. %; p = 0.023). There was no significant difference for LBR in PORs with GnRH antagonist (<35 years [35.19 vs. 28.45%; p = 0.183]; ≥35 years [12.96 vs. 14.03%; p = 0.707]), GnRH-a long (<35 years [33.33 vs. 36.99%; p = 0.597]; ≥35 years [17.44 vs. 20.28%; p = 0.574]) and long down-regulation (<35 years [58.82 vs. 41.90%; p = 0.193]; ≥35 years [43.33 vs. 25.30%; p = 0.065]). Conclusions: Growth hormone treatment may not improve live birth rate in expected poor responders.

Project description:BackgroundThe KIDScore™ Day 5 (KS-D5) model, version 3, is a general morphokinetic prediction model (Vitrolife, Sweden) for fetal heartbeat prediction after embryo transfer that was developed based on a large data set that included implantation results from a range of clinics with different patient populations, culture conditions and clinical practices. However, there was no study to comparing their pregnancy and live birth prediction ability among different maternal age. The aim of this study is to analyze the performance of KS-D5 in predicting pregnancy and live birth in various maternal age groups after single vitrified-warmed blastocyst transfer (SVBT).MethodsA total of 2486 single vitrified-warmed blastocyst transfer (SVBT) cycles were analyzed retrospectively. Confirmed fetal heartbeat positive (FHB+) and live birth (LB+) rates were stratified by Society for Assisted Reproductive Technology (SART) maternal age criteria (< 35, 35-37, 38-40, 41-42 and ≥ 43 years of age). Within each age group, the performance of the prediction model was calculated using the AUC, and the results were compared across the age groups.ResultsIn all age groups, the FHB+ rates decreased as the KIDScore decreased (P < 0.05). Conversely, the AUCs increased as the maternal age increased. The AUC of the < 35 age group (0.589) was significantly lower than the AUCs of the 41-42 age group (0.673) and the ≥43 age group (0.737), respectively (P < 0.05). In all age groups, the LB+ rates decreased as the KIDScore decreased (P < 0.05). Conversely, the AUCs increased as the maternal age increased. The AUC of the ≥43 age group (0.768) was significantly higher than the AUCs of other age groups (P < 0.05; < 35 age group = 0.596, 35-37 age group = 0.640, 38-40 age group = 0.646, 41-42 age group = 0.679).ConclusionsIn the present study, we determined that the KIDScore model worked well for prediction of pregnancy and live birth outcomes in advanced age patients.

Dataset Information

ALADDIN study: does assisted hatching of vitrified/warmed blastocysts improve live birth rate? Protocol for a multicentric randomised controlled trial.

Publications

ALADDIN study: does assisted hatching of vitrified/warmed blastocysts improve live birth rate? Protocol for a multicentric randomised controlled trial.

Similar Datasets

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