E-Freeze: Freezing of embryos in assisted conception

Conditions

Infertility Pregnancy and Childbirth Infertility

Yangmei Li, Jenny McLeish, Pollyanna Hardy, Christina Cole, Claire Carson et al. (7 authors)

Human Reproduction Open2024-01-016 citations

Transfer of thawed frozen embryo versus fresh embryo to improve the healthy baby rate in women undergoing IVF: the E-Freeze RCT

Abha Maheshwari, Vasha Bari, Jennifer Bell, Siladitya Bhattacharya, Priya Bhide et al. (33 authors)

Health Technology Assessment2022-05-0118 citations

10.3310/aefu1104

E-Freeze - a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation: a statistical analysis plan.

Bell JL, Hardy P, Greenland M, Juszczak E, Cole C, Maheshwari A, Bhattacharya S, Linsell L.

2020-06-303 citations

10.1186/s13063-020-04441-9

Study protocol: E-freeze - freezing of embryos in assisted conception: a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation.

Maheshwari A, Bhattacharya S, Bowler U, Brison D, Child T, Cole C, Coomarasamy A, Cutting R, Harbottle S, Hardy P, Juszczak E, Khalaf Y, Kurinczuk JJ, Lavery S, Lewis-Jones C, Macklon N, Raine-Fenning NJ, Rajkohwa M, Scotland G, Troup S.

2019-06-1316 citations

10.1186/s12978-019-0737-2

Interventions

Couples will be randomly allocated to either the standard care or intervention arm. Standard care arm: Women will undergo fresh embryo transfer on day 3 or 5 (after egg collection). Intervention a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current participant inclusion criteria (as of 24/01/2018): 1. The female partner is between 18 and 42 years of age at the start of treatment (i.e. start of ovarian stimulation) 2. Couples who are undergoing their first second or third cycle of IVF/ICSI treatment 3. Both partners are resident in the UK 4. Both partners are able to provide written informed consent Previous participant inclusion criteria 1. The female partner is between 18 and 42 years of age at the start of treatment (i.e. start of ovarian stimulation) 2. Couples who are undergoing their first cycle of IVF/ICSI treatment 3. Both partners are resident in the UK 4. Both partners are able to provide written informed consent

Exclusion criteria

Exclusion criteria: Couples in whom: 1. Donor gametes are used 2. Pre-implantation genetic diagnosis is performed 3. Elective freezing of all embryos is preferred or clinically indicated (e.g. severe risk of OHSS)

Design outcomes

Primary

Measure	Time frame
Health of the baby is determined by medical staff at the time of birth.	—

Secondary

Measure	Time frame
1. Live birth rate 2. Pregnancy rate (defined as positive pregnancy test - 2 weeks after embryo transfer) 3. Clinical pregnancy rate (a pregnancy diagnosed by ultrasonic visualisation of one or more gestational sacs or definitive clinical signs of pregnancy; ectopic counts as clinical pregnancy; multiple gestational sacs count as one clinical pregnancy) 4. Ongoing pregnancy (pregnancy with presence of foetal heart beat) 5. Ovarian hyperstimulation syndrome (OHSS) 6. Miscarriage rate 7. Gestational diabetes mellitus (GDM) 8. Multiple pregnancy 9. Hypertensive disorders of pregnancy (comprising pregnancy induced hypertension; pre-eclampsia and eclampsia) 10. Antepartum haemorrhage 11. Preterm delivery (defined as delivery at 90th centile for gestation, based on standardised charts) 16. Small for gestational age (defined as less than 10th centile for gestational age at delivery) 17. Congenital anomaly (all congenital anomalies identified will be included) 18. Perinatal mortality (late as well as early neonatal deaths, up to 28 days after birth) 19. Evaluation of emotional state 20. Health economic outcome measures: 20.1. Costs to the health service of treatment, pregnancy and delivery care 20.2. Modelled long-term costs of health and social care, and broader societal costs	—

Measure

Time frame

1. Live birth rate 2. Pregnancy rate (defined as positive pregnancy test - 2 weeks after embryo transfer) 3. Clinical pregnancy rate (a pregnancy diagnosed by ultrasonic visualisation of one or more gestational sacs or definitive clinical signs of pregnancy; ectopic counts as clinical pregnancy; multiple gestational sacs count as one clinical pregnancy) 4. Ongoing pregnancy (pregnancy with presence of foetal heart beat) 5. Ovarian hyperstimulation syndrome (OHSS) 6. Miscarriage rate 7. Gestational diabetes mellitus (GDM) 8. Multiple pregnancy 9. Hypertensive disorders of pregnancy (comprising pregnancy induced hypertension; pre-eclampsia and eclampsia) 10. Antepartum haemorrhage 11. Preterm delivery (defined as delivery at 90th centile for gestation, based on standardised charts) 16. Small for gestational age (defined as less than 10th centile for gestational age at delivery) 17. Congenital anomaly (all congenital anomalies identified will be included) 18. Perinatal mortality (late as well as early neonatal deaths, up to 28 days after birth) 19. Evaluation of emotional state 20. Health economic outcome measures: 20.1. Costs to the health service of treatment, pregnancy and delivery care 20.2. Modelled long-term costs of health and social care, and broader societal costs

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Countries

England, Scotland, United Kingdom

Contacts

Public ContactChristina Cole

christina.cole@npeu.ox.ac.uk-

Outcome results

None listed