Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04488861 |
Other study ID # |
NHS001747 V2.0 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
March 15, 2021 |
Est. completion date |
September 2024 |
Study information
Verified date |
March 2024 |
Source |
Manchester Academic Health Science Centre |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
This is a study of the feasibility of a translational research clinic for pregnancies
conceived by in vitro fertilisation (IVF). A group of at least 120 pregnancies (of which, at
least 80 IVF-conceived) will be followed from early pregnancy to delivery, in order to gain
early insights into the growth of the baby before birth, the physical and emotional
adaptation of the mother to the pregnancy and how the placenta works. The investigators will
collect preliminary data on how these factors may differ between pregnancies conceived with
and without IVF, and between different IVF treatment modalities such as fresh or "frozen"
embryo transfer IVF. The study aims to understand the practicalities of such a clinic, to
identify barriers to participation in the clinic, to assess the uptake of different research
measurements and to identify key measurements/time points with the greatest potential to
identify and understand the origin of fetal growth and maternal adaptation differences after
IVF conception in a full scale study.
Description:
The primary objective of the study is to test the feasibility of establishing the first
IVF-conceived pregnancy antenatal clinic specifically to collect longitudinal data relating
to the growth of the baby in the womb, how the mother's heart and blood vessels adapt to the
increased workload of pregnancy, and how the mother's emotional health (particularly stress
and anxiety) varies throughout pregnancy.
The feasibility of the study protocol will be assessed using stop/go (or progression)
criteria, to help determine whether future, larger scale studies of the same should be
commenced. The information gathered to answer the primary and secondary outcomes of the
study's primary objective will be essential for understanding, and overcoming, potential
barriers to recruitment to future cohort studies within the clinic. It will enable the
researchers to plan future studies with sufficient sample size to answer the specified
question, realistic recruitment targets and timescales to achieve this, and using
investigations that are shown to be acceptable to the majority of individuals in the target
population. The secondary objective of the study is to gather preliminary data relating to
the effects of fresh and frozen embryo transfer IVF on fetal, maternal and placental health.
The study is based on the design of several successful pregnancy cohort studies (such as the
Tommy's Project), which run through five translational research clinics in St. Mary's
Hospital, Manchester University Hospitals National Health Service (NHS) Foundation Trust:
VELOCITY clinic, Lupus in Pregnancy service, Manchester Placenta Clinic, Rainbow clinic and
Manchester Antenatal Vascular Service. The START clinic replicates the model of care offered
through these existing clinics, offering the same levels of specialised, continuity of care
to individuals who have conceived by IVF. These successful recruitment and retention within
these studies gives confidence in the acceptability of the study.
The study design is a cohort study. This is where individual participants can be divided into
groups by specified characteristics, in this case whether or not they had conceived by IVF or
not (or sub-categorised by individual factors within the IVF treatment process, such as
whether the embryo was transferred fresh or after a period of cryopreservation). No active
intervention (medicine or procedure) will be administered during the study. However, it is
known that health outcomes of individuals participating in research may be influenced by the
experience of participating in the study itself. For this reason the investigators will also
recruit "control" participants (those who have conceived without IVF, either spontaneously or
with medication to aid the release of eggs, known as ovulation induction). By comparing the
two groups, this will enable the research to isolate the specific effects of the
IVF-conception, from the effects of being highly monitored in a research study. The
investigators intend to recruit a minimum of 120 individuals across a period of three years,
with approximately 4 individuals who have conceived by IVF to every 1 individual who has
conceived without IVF.
Appointments in the START clinic will be arranged roughly 4-6 weekly (at approximately 9, 17,
23, 28, 33, 37 and 41 weeks). At each appointment the patient will be reviewed by a doctor
and midwife from a small team of clinicians who will provide continuity of care. Routine
scheduled antenatal care will be performed, along with additional measurements of fetal and
placental growth and cardiovascular function, questionnaires relating to environmental
exposures, modifiable risks, and emotional health, and samples of maternal blood, urine,
saliva and hair. More frequent appointments will be scheduled according to local hospital
guidance if complications of pregnancy are suspected or confirmed, this may mean that
clinical measurements and ultrasound examinations are performed more frequently than at the
planned study visits. Questionnaires and biological samples will only be
administered/obtained at the (study visit closest to) stated gestational intervals.
Participants will be made aware of which measurements are part of standard antenatal care and
which investigations are for research; research measurements will be analysed blinded to
participant identity/pregnancy outcome after conclusion of the pregnancy and will not
contribute to their care during or after the pregnancy. Participants can decline particular
investigations entirely or on occasion without detriment to their overall care. Where
necessary, according to the individual needs of the participant, antenatal care will be
shared with community midwives and other antenatal services where additional appointments are
required outside the stated schedule.
At birth, the placenta and fetal blood contained within it after clamping of the umbilical
cord, will be collected. Placental tissue may be used immediately after birth in experiments
to study how it functions, or small amounts may be processed and stored (according to local
standard operating procedures) for later assessment of its structure and functional
footprint. Should histopathological examination of the placenta be indicated for clinical
reasons (<5% of all pregnancies), the remaining placental tissue will be made available for
this purpose according to standard local protocols for combined research and
histopathological placental examination; otherwise unused placental tissue will be disposed
sensitively according to local National Health Service procedures. Prior to discharge from
the hospital, and preferably within 3 days of birth, the baby will be measured (using a tape
measure) once for head, abdominal and thigh circumference, and length. Their skinfold
thickness (to measure fat depth) over the shoulder blade and under the upper arm will be
measured using purpose-built callipers. The baby will be kept warm and comfortable
throughout, and the examination paused or stopped should the baby show distress, need feeding
or changing or any medical intervention be required.