E-Freeze: Freezing of embryos in assisted conception

• Register: ISRCTN
• Last refreshed on: 6 June 2022
• Main ID: ISRCTN61225414
• Date of registration: 29/12/2015
• Prospective Registration: Yes
• Primary sponsor: NHS Grampian
• Public title: E-Freeze: Freezing of embryos in assisted conception
• Scientific title: 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 fertilization.
• Date of first enrolment: 01/01/2016
• Target sample size: 1086
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN61225414
• Study type: Interventional
• Study design: Pragmatic multi-centre parallel-group randomised controlled trial (Other)
• Phase: Not Applicable

Countries of recruitment

England, Scotland, United Kingdom

Contacts

• Name: Christina Cole

• Name: Abha Maheshwari

Key inclusion & exclusion 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:
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)


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Infertility
Pregnancy and Childbirth
Infertility

Intervention(s)

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 arm: All good quality embryos will be frozen and couples will undergo frozen thawed embryo transfer within 3 months of the egg collection process. Couples will attend for a clinic visit and additional monitoring visits before frozen embryo transfer is performed.

Data be collected using bespoke electronic data collection forms at 6 time points between consent and 6 weeks post delivery. An emotions questionnaire will also be completed both after consent and at embryo transfer to understand how couples are feeling. And an economic questionnaire will be used to understand time and travel expenses accrued during their treatment.

Primary Outcome(s)

Health of the baby is determined by medical staff at the time of birth.

Secondary Outcome(s)

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 <37 completed weeks)
12. Very preterm delivery (defined as delivery at <32 completed weeks)
13. Low birth weight (defined as weight < 2500 g at birth)
14. Very low birth weight (defined as < 1500 g at birth)
15. Large for gestational age (defined as birth weight >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

Secondary ID(s)

N/A

Source(s) of Monetary Support

National Institute for Health Research

Secondary Sponsor(s)

University of Aberdeen

Ethics review

Status:
Approval date:
Contact:

North of Scotland Research Ethics Committee, 12/11/2015, ref: 15/NS/0114

Results

• Results available: Yes
• Date Completed: 31/01/2021