A pragmatic randomised controlled trial of conventional versus increased concentration sucrose in freezing and thawing solutions for human embryos

Maureen Wood, Jill Ann Mollison, Kirsten Ann Harrild, Elizabeth Ferguson, Thelma McKay, Arasaratnam Srikantharajah, Lorna Margaret Bell, Siladitya Bhattacharya

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Abstract

BACKGROUND Intact frozen-thawed embryos have a greater potential than damaged embryos to establish successful pregnancies. This study aimed to determine whether elevated concentrations of sucrose during freezing would increase the proportion of patients with =50% of embryos intact after thawing (primary outcome), and improve clinical outcome.
METHODS In a two arm, parallel group, pragmatic trial, IVF/ICSI couples were randomized prospectively to have their supernumerary embryos frozen in a medium containing 0.1 M sucrose (control; n = 99) or 0.3 M sucrose (intervention; n = 102).
RESULTS More control (74/99) than intervention (63/102) couples had at least one embryo thawed (P = 0.07). Significantly more (P = 0.005) intervention (53/63) than control (45/74) couples had =50% of embryos intact. Freezing in a medium containing 0.3 M sucrose increased by 3.4-fold [95% confidence interval (CI) (1.45, 7.82)] the likelihood of a couple having =50% of their embryos intact. In the fresh cycle, live birth rate per transfer was similar in the control (35/95) and intervention (36/93) groups (P = 0.91). More control (19/63) than intervention (9/59) couples had a live birth after frozen embryo transfer (P = 0.08). When fresh and frozen cycles were combined, fewer intervention (n = 102) than control (n = 99) couples had at least one live birth (42 versus 53%). The difference in cumulative live birth rate was not significant [hazard ratio = 0.75, 95% CI (0.49, 1.13); P = 0.17].
CONCLUSIONS Increasing the concentration of sucrose in the freezing medium improves embryo survival, but this is not reflected by increased cumulative birth rates.
Original languageEnglish
Pages (from-to)1987-1996
Number of pages10
JournalHuman Reproduction
Volume26
Issue number8
Early online date16 May 2011
DOIs
Publication statusPublished - 2011

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Freezing
Sucrose
Embryonic Structures
Randomized Controlled Trials
Live Birth
Birth Rate
Pragmatic Clinical Trials
Confidence Intervals
Intracytoplasmic Sperm Injections
Embryo Transfer
Pregnancy

Keywords

  • freezing
  • embryo
  • sucrose
  • prospective RCT
  • cumulative live birth

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A pragmatic randomised controlled trial of conventional versus increased concentration sucrose in freezing and thawing solutions for human embryos. / Wood, Maureen; Mollison, Jill Ann; Harrild, Kirsten Ann; Ferguson, Elizabeth; McKay, Thelma; Srikantharajah, Arasaratnam; Bell, Lorna Margaret; Bhattacharya, Siladitya.

In: Human Reproduction, Vol. 26, No. 8, 2011, p. 1987-1996.

Research output: Contribution to journalArticle

Wood, Maureen ; Mollison, Jill Ann ; Harrild, Kirsten Ann ; Ferguson, Elizabeth ; McKay, Thelma ; Srikantharajah, Arasaratnam ; Bell, Lorna Margaret ; Bhattacharya, Siladitya. / A pragmatic randomised controlled trial of conventional versus increased concentration sucrose in freezing and thawing solutions for human embryos. In: Human Reproduction. 2011 ; Vol. 26, No. 8. pp. 1987-1996.
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abstract = "BACKGROUND Intact frozen-thawed embryos have a greater potential than damaged embryos to establish successful pregnancies. This study aimed to determine whether elevated concentrations of sucrose during freezing would increase the proportion of patients with =50{\%} of embryos intact after thawing (primary outcome), and improve clinical outcome. METHODS In a two arm, parallel group, pragmatic trial, IVF/ICSI couples were randomized prospectively to have their supernumerary embryos frozen in a medium containing 0.1 M sucrose (control; n = 99) or 0.3 M sucrose (intervention; n = 102). RESULTS More control (74/99) than intervention (63/102) couples had at least one embryo thawed (P = 0.07). Significantly more (P = 0.005) intervention (53/63) than control (45/74) couples had =50{\%} of embryos intact. Freezing in a medium containing 0.3 M sucrose increased by 3.4-fold [95{\%} confidence interval (CI) (1.45, 7.82)] the likelihood of a couple having =50{\%} of their embryos intact. In the fresh cycle, live birth rate per transfer was similar in the control (35/95) and intervention (36/93) groups (P = 0.91). More control (19/63) than intervention (9/59) couples had a live birth after frozen embryo transfer (P = 0.08). When fresh and frozen cycles were combined, fewer intervention (n = 102) than control (n = 99) couples had at least one live birth (42 versus 53{\%}). The difference in cumulative live birth rate was not significant [hazard ratio = 0.75, 95{\%} CI (0.49, 1.13); P = 0.17]. CONCLUSIONS Increasing the concentration of sucrose in the freezing medium improves embryo survival, but this is not reflected by increased cumulative birth rates.",
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T1 - A pragmatic randomised controlled trial of conventional versus increased concentration sucrose in freezing and thawing solutions for human embryos

AU - Wood, Maureen

AU - Mollison, Jill Ann

AU - Harrild, Kirsten Ann

AU - Ferguson, Elizabeth

AU - McKay, Thelma

AU - Srikantharajah, Arasaratnam

AU - Bell, Lorna Margaret

AU - Bhattacharya, Siladitya

PY - 2011

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N2 - BACKGROUND Intact frozen-thawed embryos have a greater potential than damaged embryos to establish successful pregnancies. This study aimed to determine whether elevated concentrations of sucrose during freezing would increase the proportion of patients with =50% of embryos intact after thawing (primary outcome), and improve clinical outcome. METHODS In a two arm, parallel group, pragmatic trial, IVF/ICSI couples were randomized prospectively to have their supernumerary embryos frozen in a medium containing 0.1 M sucrose (control; n = 99) or 0.3 M sucrose (intervention; n = 102). RESULTS More control (74/99) than intervention (63/102) couples had at least one embryo thawed (P = 0.07). Significantly more (P = 0.005) intervention (53/63) than control (45/74) couples had =50% of embryos intact. Freezing in a medium containing 0.3 M sucrose increased by 3.4-fold [95% confidence interval (CI) (1.45, 7.82)] the likelihood of a couple having =50% of their embryos intact. In the fresh cycle, live birth rate per transfer was similar in the control (35/95) and intervention (36/93) groups (P = 0.91). More control (19/63) than intervention (9/59) couples had a live birth after frozen embryo transfer (P = 0.08). When fresh and frozen cycles were combined, fewer intervention (n = 102) than control (n = 99) couples had at least one live birth (42 versus 53%). The difference in cumulative live birth rate was not significant [hazard ratio = 0.75, 95% CI (0.49, 1.13); P = 0.17]. CONCLUSIONS Increasing the concentration of sucrose in the freezing medium improves embryo survival, but this is not reflected by increased cumulative birth rates.

AB - BACKGROUND Intact frozen-thawed embryos have a greater potential than damaged embryos to establish successful pregnancies. This study aimed to determine whether elevated concentrations of sucrose during freezing would increase the proportion of patients with =50% of embryos intact after thawing (primary outcome), and improve clinical outcome. METHODS In a two arm, parallel group, pragmatic trial, IVF/ICSI couples were randomized prospectively to have their supernumerary embryos frozen in a medium containing 0.1 M sucrose (control; n = 99) or 0.3 M sucrose (intervention; n = 102). RESULTS More control (74/99) than intervention (63/102) couples had at least one embryo thawed (P = 0.07). Significantly more (P = 0.005) intervention (53/63) than control (45/74) couples had =50% of embryos intact. Freezing in a medium containing 0.3 M sucrose increased by 3.4-fold [95% confidence interval (CI) (1.45, 7.82)] the likelihood of a couple having =50% of their embryos intact. In the fresh cycle, live birth rate per transfer was similar in the control (35/95) and intervention (36/93) groups (P = 0.91). More control (19/63) than intervention (9/59) couples had a live birth after frozen embryo transfer (P = 0.08). When fresh and frozen cycles were combined, fewer intervention (n = 102) than control (n = 99) couples had at least one live birth (42 versus 53%). The difference in cumulative live birth rate was not significant [hazard ratio = 0.75, 95% CI (0.49, 1.13); P = 0.17]. CONCLUSIONS Increasing the concentration of sucrose in the freezing medium improves embryo survival, but this is not reflected by increased cumulative birth rates.

KW - freezing

KW - embryo

KW - sucrose

KW - prospective RCT

KW - cumulative live birth

U2 - 10.1093/humrep/der147

DO - 10.1093/humrep/der147

M3 - Article

VL - 26

SP - 1987

EP - 1996

JO - Human Reproduction

JF - Human Reproduction

SN - 0268-1161

IS - 8

ER -