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Fresh embryo transfer versus freeze-only after in vitro maturation with a pre-maturation step in women with high antral follicle count: a randomized controlled pilot study

  • Assisted Reproduction Technologies
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Abstract

Purpose

In vitro maturation (IVM) is an alternative to in vitro fertilization (IVF) for women at high risk of developing ovarian hyperstimulation syndrome (OHSS). This study determined the effectiveness and safety of a freeze-only strategy versus fresh embryo transfer (ET) after IVM with a pre-maturation step (CAPA-IVM) in women with a high antral follicle count (AFC).

Methods

This randomized, controlled pilot study (NCT04297553) was conducted between March and November 2020. Forty women aged 18–37 years with a high AFC (≥24 follicles in both ovaries) undergoing one cycle of CAPA-IVM were randomized to a freeze-only strategy with subsequent frozen ET (n = 20) or to fresh ET (n = 20). The primary endpoint was ongoing pregnancy resulting in live birth after the first ET of the started treatment cycle.

Results

The ongoing pregnancy rate in the freeze-only group (65%) was significantly higher than that in the fresh ET group (25%; p = 0.03), as was the live birth rate (60% versus 20%; p = 0.02). Clinical pregnancy rate was numerically, but not significantly, higher after frozen versus fresh ET (70% versus 35%; p = 0.06), while the number of day 3 or good quality embryos, endometrial thickness on the day of oocyte pick-up, implantation rate, and positive pregnancy test rate did not differ significantly between groups. No cases of OHSS were observed, and miscarriage and multiple pregnancy rates were similar in the two groups.

Conclusions

These findings suggest that the effectiveness of CAPA-IVM could be improved considerably by using a freeze-only strategy followed by frozen ET in subsequent cycles.

Trial registration number:

NCT04297553 (www.clinicaltrials.gov)

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Data availability

The datasets generated and/or analyzed during the current study are not publicly available due to patient privacy but are available from the corresponding author on reasonable request.

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Funding

This work was funded by the Vietnam National Foundation for Science and Technology Development (NAFOSTED; grant number FWO.106-YS.2017.02) and by the Fund for Research Flanders (FWO) under grant number G.OD97.18N. The study sponsors were not involved in the study design, the collection, analysis, and interpretation of data, the writing of the report, or the decision to submit the paper for publication. The corresponding author had full access to all the data in the study and had final responsibility to submit for publication.

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Authors and Affiliations

Authors

Contributions

LNV, LKN, AHL, HHP. VNAH, HLL, TDP, VQD, THP, JS, and TMH designed the study and monitored data collection. The statistical analysis plan was written by TDP and LNV. Data analysis was conducted by TDP, who acts as guarantor of the data and the analyses. Planning for the first draft of the manuscript was undertaken by LNV, LKN, and TDP. The first draft of the paper was written by LNV. All authors were involved in the decision to publish the paper and in critical revisions of the manuscript. LNV acts as overall guarantor and accepts full responsibility for the work and/or the conduct of the study, had access to the data, and controlled the decision to publish.

Corresponding author

Correspondence to Lan N. Vuong.

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Conflict of interest

LNV has received speaker and conference fees from Merck, and grant, speaker, and conference fees from Merck Sharpe & Dohme and Ferring. TMH has received speaker fees from Merck, Merck Sharp & Dohme and Ferring. 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 USA (US10392601B2) and Europe (EP3234112B1).

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Vuong, L.N., Nguyen, L.K., Le, A.H. et al. Fresh embryo transfer versus freeze-only after in vitro maturation with a pre-maturation step in women with high antral follicle count: a randomized controlled pilot study. J Assist Reprod Genet 38, 1293–1302 (2021). https://doi.org/10.1007/s10815-021-02180-7

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  • DOI: https://doi.org/10.1007/s10815-021-02180-7

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