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Title: | In-vitro maturation of oocytes versus conventional IVF in women with infertility and a high antral follicle count: A randomized non-inferiority controlled trial. | Authors: | Norman R.J.;Pham T.D.;Wang R.;Smitz J.;Gilchrist R.B.;Mol B.W. ;Vuong L.N.;Ho V.N.A.;Ho T.M.;Dang V.Q.;Phung T.H.;Giang N.H.;Le A.H. | Institution: | (Vuong) Department of Obstetrics and Gynaecology, University of Medicine and Pharmacy, Ho Chi Minh City, Vietnam (Vuong, Ho, Ho, Dang, Phung, Giang, Le, Pham) My Duc Hospital and Hope Research Center, Ivfmd, Ho Chi Minh City, Vietnam (Wang, Mol) Department of Obstetrics and Gynaecology, School of Clinical Sciences at Monash Health, Monash University, Melbourne, VIC, Australia (Smitz) Follicle Biology Laboratory, Belgium 5School of Women's and Children's Health, Free University of Brussels (VUB), NSW, Australia (Gilchrist) Robinson Research Institute and Adelaide Medical School, University of Adelaide, Adelaide, SA, Australia (Norman) Fertility Sa, Adelaide, SA, Australia (Norman) Department of Obstetrics and Gynaecology, University of Medicine and Pharmacy at Ho Chi Minh City, 217 Hong Bang Street, District 5, Ho Chi Minh City, Vietnam | Issue Date: | 26-Feb-2021 | Copyright year: | 2020 | Publisher: | Oxford University Press | Place of publication: | United Kingdom | Publication information: | Human Reproduction. 35 (11) (pp 2537-2547), 2020. Date of Publication: 01 Nov 2020. | Journal: | Human Reproduction | Abstract: | STUDY QUESTION: Is one cycle of IVM non-inferior to one cycle of conventional in IVF with respect to live birth rates in women with high antral follicle counts (AFCs)? SUMMARY ANSWER: We could not demonstrate non-inferiority of IVM compared with IVF. WHAT IS KNOWN ALREADY: IVF with ovarian hyperstimulation has limitations in some subgroups of women at high risk of ovarian stimulation, such as those with polycystic ovary syndrome. IVM is an alternative ART for these women. IVM may be a feasible alternative to IVF in women with a high AFC, but there is a lack of data from randomized clinical trials comparing IVM with IVF in women at high risk of ovarian hyperstimulation syndrome. STUDY DESIGN, SIZE, DURATION: This single-center, randomized, controlled non-inferiority trial was conducted at an academic infertility center in Vietnam from January 2018 to April 2019. PARTICIPANTS/MATERIALS, SETTING, METHODS: In total, 546 women with an indication for ART and a high AFC (>=24 follicles in both ovaries) were randomized to the IVM (n = 273) group or the IVF (n = 273) group; each underwent one cycle of IVM with a prematuration step versus one cycle of IVF using a standard gonadotropin-releasing hormone antagonist protocol with gonadotropin-releasing hormone agonist triggering. The primary endpoint was live birth rate after the first embryo transfer. The non-inferiority margin for IVM versus IVF was-10%. MAIN RESULTS AND THE ROLE OF CHANCE: Live birth after the first embryo transfer occurred in 96 women (35.2%) in the IVM group and 118 women (43.2%) in the IVF group (absolute risk difference-8.1%; 95% confidence interval (CI)-16.6%, 0.5%). Cumulative ongoing pregnancy rates at 12 months after randomization were 44.0% in the IVM group and 62.6% in the IVF group (absolute risk difference-18.7%; 95% CI-27.3%,-10.1%). Ovarian hyperstimulation syndrome did not occur in the IVM group, versus two cases in the IVF group. There were no statistically significant differences between the IVM and IVF groups with respect to the occurrence of pregnancy complications, obstetric and perinatal complications, preterm delivery, birth weight and neonatal complications. LIMITATIONS, REASONS FOR CAUTION: The main limitation of the study was its open-label design. In addition, the findings are only applicable to IVM conducted using the prematuration step protocol used in this study. Finally, the single ethnicity population limits the external generalizability of the findings. WIDER IMPLICATIONS OF THE FINDINGS: Our randomized clinical trial compares live birth rates after IVM and IVF. Although IVM is a viable and safe alternative to IVF that may be suitable for some women seeking a mild ART approach, the current study findings approach inferiority for IVM compared with IVF when cumulative outcomes are considered. Future research should incorporate multiple cycles of IVM in the study design to estimate cumulative fertility outcomes and better inform clinical decision-making. STUDY FUNDING/COMPETING INTEREST(S): This work was partly supported by Ferring grant number 000323 and funded by the Vietnam National Foundation for Science and Technology Development (NAFOSTED) and by the Fund for Research Flanders (FWO). LNV has received speaker and conference fees from Merck, grant, speaker and conference fees from Merck Sharpe and Dohme, and speaker, conference and scientific board fees from Ferring; TMH has received speaker fees from Merck, Merck Sharp and Dohme, and Ferring; RJN has received conference and scientific board fees from Ferring, is a minor shareholder in an IVF company, and receives grant funding from the National Health and Medical Research Council (NHMRC) of Australia; BWM has acted as a paid consultant to Merck, ObsEva and Guerbet, and is the recipient of grant money from an NHMRC Investigator Grant; RBG reports grants and fellowships from the NHMRC of Australia; JS reports lecture fees from Ferring Pharmaceuticals, Biomerieux, Besins Female Healthcare and Merck, grants from Fund for Research Flanders (FWO), and is co-inventor on granted patents on CAPA-IVM methodology in the US (US10392601B2) and Europe (EP3234112B1); TDP, VQD, VNAH, NHG, AHL, THP and RW have no financial relationships with any organizations that might have an interest in the submitted work in the previous three years, and no other relationships or activities that could appear to have influenced the submitted work. TRIAL REGISTRATION NUMBER: NCT03405701 (www.clinicaltrials.gov). TRIAL REGISTRATION DATE: 16 January 2018. DATE OF FIRST PATENT'S ENROLMENT: 25 January 2018.Copyright © 2020 The Author(s) 2020. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology. All rights reserved. | DOI: | http://monash.idm.oclc.org/login?url= http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1093/humrep/deaa240 |
PubMed URL: | 32974672 [http://www.ncbi.nlm.nih.gov/pubmed/?term=32974672] | ISSN: | 0268-1161 | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/27173 | Type: | Article | Subjects: | female *female infertility/dt [Drug Therapy] human *in vitro fertilization *in vitro oocyte maturation *intermethod comparison live birth major clinical study medical research newborn disease ovary hyperstimulation ovary polycystic disease ovulation induction pregnancy complication pregnancy rate premature labor prematurity clinical outcome embryo embryo transfer ethnicity valiera adult *antral follicle count article attributable risk birth rate birth weight clinical decision making controlled study randomized controlled trial transvaginal echography Viet Nam estradiol valerate/dt [Drug Therapy] estradiol valerate/po [Oral Drug Administration] gonadorelin antagonist/dt [Drug Therapy] human menopausal gonadotropin/dt [Drug Therapy] progesterone/dt [Drug Therapy] progesterone/va [Intravaginal Drug Administration] triptorelin/dt [Drug Therapy] computer obstetric ultrasound transducer telephone embryo transfer adult *antral follicle count Article attributable risk birth rate birth weight clinical decision making clinical outcome controlled study embryo ethnicity female *female infertility / *drug therapy human *in vitro fertilization *in vitro oocyte maturation *intermethod comparison live birth major clinical study medical research newborn disease ovary hyperstimulation ovary polycystic disease ovulation induction pregnancy complication pregnancy rate premature labor prematurity randomized controlled trial transvaginal echography Viet Nam |
Type of Clinical Study or Trial: | Randomised controlled trial |
Appears in Collections: | Articles |
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