In vitro fertilization Pregnancy and Childbirth
Conditions
Interventions
A secure, web based randomisation system hosted by the Barts Women’s Health Research Centre. The randomisation will be stratified by fertility clinic, and minimised by:
1. Participant’s age (40 years
Sponsors
Queen Mary University of London
Chinese University of Hong Kong
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The inclusion criteria are broad in keeping with the latest NICE guidelines (2013) for NHS funded IVF/ICSI treatment. Participants undergoing IVF/ICSI treatment and: 1. The woman is between 18 and 42 years of age at the time of consent 2. The male partner is at least 18 years of age at the time of consent 3. Receiving the first, second or third IVF/ICSI treatment cycle 4. Both partners give written informed consent 5. Those having at least 3 2PN embryos (showing 2 pro-nucleii which is a sign of normal fertilisation) on day of fertilization check
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 06/04/2020: 1. Participants concomitantly participating in other interventional trials 2. IVF/ICSI treatment using donor gametes 3. Planned pre-implantation genetic diagnostics or screening (PGS/PGD) Previous exclusion criteria: 1. Participants who have been randomised previously to this trial 2. Participants concomitantly participating in other trials 3. IVF/ICSI treatment using donor gametes 4. Planned pre-implantation genetic diagnostics or screening (PGS/PGD)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of live births, taken from medical notes/contacting the participant; Timepoint(s): Delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 06/04/2020: Clinical efficacy outcomes: 1. Pregnancy rate measured by pregnancy test taken from medical notes; Timepoint(s): 2 weeks after embryo transfer 2. Successful implantation of embryo(s) into womb measured by total number of gestational sacs seen on ultrasound scan/total number of embryos replaced into the womb taken from medical notes; Timepoint(s): 6-8 weeks after embryo transfer. 3. Successful clinical pregnancy measured by at least one intrauterine gestational sac taken from medical notes/contacting the participant; Timepoint(s): 6-8 weeks after embryo transfer 4. Use of elective single embryo transfer (e-SET) recorded per participant, taken from medical notes; Timepoint(s): At embryo transfer 5. Embryo utilization rate (% of total embryos either transferred or frozen), taken from medical notes; Timepoint: 2-6 days after date of fertilisation check. Clinical safety outcomes: 1. Multiple pregnancy measured by two or more gestational sacs seen on ultrasound scan taken from medical notes/contacting the participant; Timepoint(s): 6-8 weeks after embryo transfer 2. Pregnancy loss recorded from medical notes/contacting the participant; Timepoint(s): 2.1. Between positive pregnancy test and 6-8 week scan 2.2. Between 6-8 week scan and 12 weeks (early miscarriage) 2.3. Between 12 and 24 weeks 2.4. Stillbirth 3. Incidence of major congenital abnormality at birth recorded as a Serious Adverse Event taken from medical notes/contacting the participant; Timepoint(s): Within 6 weeks of delivery 4. Birth weight, taken from medical notes; Timepoint: Delivery 5. Gestational age, taken from medical notes; Timepoint: Delivery 6. Ectopic pregnancy, taken from medical notes/contacting the participant; Timepoint(s): early pregnancy scan (6-8 weeks) & 24 weeks assessment Previous secondary outcome measures: Clinical efficacy outcomes: 1. Pregnancy rate measured by pregnancy test taken from medical notes; Timepoint(s): 2 weeks after | — |
Countries
England, Hong Kong, United Kingdom
Outcome results
None listed