Non-inferiority of cleavage-stage versus blastocyst-stage embryo transfer in poor prognosis IVF patients (PRECiSE trial): study protocol for a randomized controlled trial

Neuhausser, Werner M.; Vaughan, Denis A.; Sakkas, Denny; Hacker, Michele R.; Toth, Tom; Penzias, Alan S.

doi:10.1186/s12978-020-0870-y

Cited by 20 publications

(8 citation statements)

References 21 publications

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“…As culture conditions improved to support development to the blastocyst stage, many clinics shifted to extended culture to the blastocyst stage, which requires an additional 2–3 days ( Glujovsky et al, 2016 ). Two advantages of extended culture are that it enables selection of the most developmentally advanced embryos, matching the embryonic stage to when embryos normally arrive in the uterus in spontaneous pregnancies, and genetic testing on biopsied trophectoderm cells rather than earlier stage blastomeres that may affect development of the embryo proper ( Neuhausser et al, 2020 ). Some evidence suggests that blastocyst transfer improves implantation, pregnancy and live birth rates, and reduces the risk for small for gestational age compared to cleavage transfer ( Frattarelli et al, 2003 ; Papanikolaou et al, 2005 , 2006 ; Elgindy et al, 2011 ; Fernández-Shaw et al, 2015 ; De Vos et al, 2016 ; Wang et al, 2017 ).…”

Section: Introductionmentioning

confidence: 99%

Placental Abnormalities are Associated With Specific Windows of Embryo Culture in a Mouse Model

Vrooman

Rhon‐Calderón

Suri

et al. 2022

Front. Cell Dev. Biol.

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Assisted Reproductive Technologies (ART) employ gamete/embryo handling and culture in vitro to produce offspring. ART pregnancies have an increased risk of low birth weight, abnormal placentation, pregnancy complications, and imprinting disorders. Embryo culture induces low birth weight, abnormal placental morphology, and lower levels of DNA methylation in placentas in a mouse model of ART. Whether preimplantation embryos at specific stages of development are more susceptible to these perturbations remains unresolved. Accordingly, we performed embryo culture for several discrete periods of preimplantation development and following embryo transfer, assessed fetal and placental outcomes at term. We observed a reduction in fetal:placental ratio associated with two distinct windows of preimplantation embryo development, one prior to the morula stage and the other from the morula to blastocyst stage, whereas placental morphological abnormalities and reduced imprinting control region methylation were only associated with culture prior to the morula stage. Extended culture to the blastocyst stage also induces additional placental DNA methylation changes compared to embryos transferred at the morula stage, and female concepti exhibited a higher loss of DNA methylation than males. By identifying specific developmental windows of susceptibility, this study provides a framework to optimize further culture conditions to minimize risks associated with ART pregnancies.

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Section: Introductionmentioning

confidence: 99%

Placental Abnormalities are Associated With Specific Windows of Embryo Culture in a Mouse Model

Vrooman

Rhon‐Calderón

Suri

et al. 2022

Front. Cell Dev. Biol.

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“…However, since we matched on female age, number of oocytes retrieved and number of zygotes on Day 1, subpopulations of women with low ovarian reserve and/or low fertilization rate were not analyzed. These discrepancies are to be elucidated in the ongoing multicenter, non-inferiority, randomized controlled PRECISE trial (ClinicalTrials.gov Identifier: NCT03764865) aimed at comparing blastocyst to cleavage-stage embryo transfer in poor-prognosis patients (defined as having ≤5 zygotes on Day 1 after fertilization), whose protocol has recently been published ( Neuhausser et al , 2020 ). The primary outcome is LBR per retrieval (time frame: 9 months).…”

Section: Discussionmentioning

confidence: 99%

No difference in cumulative live birth rates between cleavage versus blastocyst transfer in patients with four or fewer zygotes: results from a retrospective study

Croo

Colman

Sutter

et al. 2022

Human Reproduction Open

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STUDY QUESTION Is the cumulative live birth rate (CLBR) per oocyte collection cycle (OCC) comparable after cleavage-stage or blastocyst-stage transfer in combination with supernumerary blastocyst vitrification on day 5 (D5) in patients with four or fewer zygotes on day 1? SUMMARY ANSWER The CLBR in a fresh blastocyst-transfer or cleavage-stage transfer policy followed by vitrification on D5 is comparable in patients with four or fewer zygotes. WHAT IS KNOWN ALREADY Blastocyst transfer enhances self-selection of the embryo and shortens time to pregnancy in patients with normal or high ovarian response. Whether these advantages are also present in patients with a low ovarian response and/or a limited number of available zygotes is a continuous debate. STUDY DESIGN, SIZE, DURATION This was a retrospective, observational cohort study of 2,359 consecutive OCCs between January 2014 and December 2018. According to a shift in transfer policy in our center, 571 OCCs had been scheduled for a fresh transfer on day 3 (D3) and 1,788 on D5. The D5 group was matched to the D3 group by propensity score (PS) matching according to multiple maternal baseline covariates. After PS matching, there were 571 OCCs in each group. PARTICIPANTS/MATERIALS, SETTING, METHODS OCC scheduled for a D3 transfer (n = 571) or for a D5 transfer (n = 1788) were matched by PS matching in a 1:1 ratio accounting for potential confounding factors associated with CLBR. The model included patient characteristics, such as maternal age and cycle rank, as well as treatment characteristics such as GnRH analogue regimen and ovarian response. Embryological variables included the number of zygotes and number of 6-7 and 8-cell embryos on D3. The delivery outcomes of the fresh treatment cycle and the consecutive vitrified-warmed embryo transfers were analysed up to the first live birth. The primary endpoint of this study was CLBR per OCC. Secondary outcomes were live birth rate per fresh transfer and embryo implantation rate per transferred embryo. MAIN RESULTS AND THE ROLE OF CHANCE The CLBR per OCC was comparable between the D5 and D3 groups (16.8% versus 17.7%, respectively, p = 0.600). Live birth rates per OCC did not differ between a cleavage-stage transfer and blastocyst-stage transfer policy (15.2% versus 12.4%, respectively, p = 0.160). In the D5 group, 201 cycles did not result in a blastocyst to perform an embryo transfer or cryopreservation; in the D3 group only 59 cycles did not have an embryo transfer because of poor embryo quality (35.2% versus 10.3%, respectively; p < 0.001). A significantly higher number of fresh double embryo transfers were performed in the D3 group compared to D5 (23.8% versus 7.0%, respectively, p < 0.001). LIMITATIONS, REASONS FOR CAUTION Although adjusted for important confounders in the PS matching, BMI and embryo quality of the transferred embryo(s) were not taken into account. This study is limited by its retrospective design and is a single centre study, which may limit the generalizability of our findings. WIDER IMPLICATIONS OF THE FINDINGS The CLBR in a fresh blastocyst-transfer or cleavage-stage transfer policy followed by vitrification on D5 is comparable. A fresh embryo transfer on D3 can still be considered in patients with a poor ovarian response and/or limited number of zygotes when combined with blastocyst vitrification without impacting the overall CLBR of the cycle. STUDY FUNDING/COMPETING INTEREST(S) No external funding was obtained for this study. The are no conflicts of interest to declare. TRIAL REGISTRATION NUMBER This retrospective study was approved by the local ethical committee at Ghent University Hospital (B 670201731234).

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“…In our unit, we still use the policy of embryo transfer on day 2 or 3 because the evidence of an increasing of clinical or live pregnancy rate following fresh blastocyst transfer in comparison with a fresh cleavage stage transfer are low [ 68 , 69 ]. Despite a recent study [ 70 ] suggesting better cumulative live birth change using blastocyst stage transfer strategy, there is to date no consensus about the first line transfer-policy due to conflicting results.…”

Section: Discussionmentioning

confidence: 99%

Impact of endometriosis on oocyte morphology in IVF-ICSI: retrospective study of a cohort of more than 6000 mature oocytes

Robin

Decanter

et al. 2021

Reprod Biol Endocrinol

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Background Infertility associated with endometriosis can be explained by several non-exclusive mechanisms. The oocyte plays a crucial role in determining embryonic competence and this is particularly relevant for in vitro fertilization (IVF) outcomes. According to some authors, the morphology of oocytes could also be a non-invasive marker of oocyte quality. The aim of this study was to evaluate the relationship between endometriosis and oocyte morphology after controlled ovarian stimulation for intracytoplasmic sperm injection (ICSI) on a large oocyte cohort. Methods Single-center comparative retrospective study in the academic In Vitro Fertilization (IVF) unit of the Lille University Hospital. A total of 596 women treated for IVF-ICSI with ejaculated spermatozoa for sperm alterations were included. They were classified as endometriosis (n = 175) or control groups (n = 401). The morphological evaluation of 2,016 mature oocytes from 348 cycles of patients with endometriosis was compared with that of 4,073 mature oocytes from 576 control cycles. The main outcome measures were Average Oocyte Quality Index (AOQI) and metaphase II oocyte morphological scoring system (MOMS). Comparison of groups was carried out by a mixed linear model and by a generalized estimation equation model with a "patient" random effect to consider that a patient might have several attempts. Results No difference in AOQI and MOMS scores was found between endometriosis and control women (adjusted p = 0.084 and 0.053, respectively). In case of endometriosis, there were significantly fewer metaphase II oocytes retrieved, embryos obtained, grade 1 embryos and number of cumulative clinical pregnancies compared to controls. In the endometriosis group, endometriosis surgery was associated with a reduced number of mature oocytes retrieved, and the presence of endometrioma(s) was associated with some abnormal oocyte shapes. Nevertheless, no difference concerning the AOQI and MOMS scores was found in these subgroups. Conclusion Endometriosis does not have a negative impact on oocytes’ morphology in IVF-ICSI. Trial registration On December 16, 2019, the Institutional Review Board of the Lille University Hospital gave unrestricted approval for the anonymous use of all patients’ clinical, hormonal and ultrasound records (reference DEC20150715-0002).

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Non-inferiority of cleavage-stage versus blastocyst-stage embryo transfer in poor prognosis IVF patients (PRECiSE trial): study protocol for a randomized controlled trial

Cited by 20 publications

References 21 publications

Placental Abnormalities are Associated With Specific Windows of Embryo Culture in a Mouse Model

Placental Abnormalities are Associated With Specific Windows of Embryo Culture in a Mouse Model

No difference in cumulative live birth rates between cleavage versus blastocyst transfer in patients with four or fewer zygotes: results from a retrospective study

Impact of endometriosis on oocyte morphology in IVF-ICSI: retrospective study of a cohort of more than 6000 mature oocytes

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