- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04488861
The START Clinic: a Feasibility Study (START)
A Feasibility Study of a Translational Research Antenatal Clinic for IVF-conceived Pregnancies: The St Mary's After Reproductive Technology (START) Clinic
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Manchester, United Kingdom, M13 9WL
- Maternal and Fetal Health Research Centre, University of Manchester
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Maternal age at enrolment of between 18 -39 years
- (Current pregnancy) Conception by IVF, or spontaneously ("naturally") within 12 months of trying to conceive, or with medication to stimulate egg release (ovulation induction) after a delay in conceiving of more than 12 months
- Antenatal care and delivery planned at St. Mary's Hospital, Manchester
- Pregnant with one, live baby within the womb (known medically as a singleton, viable, intrauterine pregnancy) at the time of recruitment
- Able to give informed consent, with or without the use of interpretation services
Exclusion Criteria:
- Prisoners
- Maternal age at enrolment younger than 18 or greater than or equal to 40 years.
- Conception in current pregnancy by non-IVF, non-Intra Cytoplasmic Sperm Injection fertility treatment (e.g. intrauterine insemination, intracervical insemination, gamete or zygote intrafallopian transfer), ovulation induction without delay in conception of at least 12 months' duration, or spontaneous conception after a delay in conception of more than 12 months, or during use of (regular or emergency hormonal or intrauterine) contraception. Conception following condom failure without emergency hormonal contraception use is not an exclusion criteria.
- Potential participant or partner not willing to consent to disclosure of fertility treatment records to the research team
- Antenatal care and delivery planned at another hospital
- Pre-existing maternal medical condition requiring specialist antenatal care beyond the scope of the SMART clinic, including BMI > 35, pre-existing diabetes and hypertension
- Miscarriage or fetal death in utero at the point of recruitment
- Presence of detected clinically significant (as defined by clinician in charge of care) fetal abnormalities
- Refusal of consent, including consent of the participant and any partner to access to fertility treatment records (as applicable)
- Language barrier not overcome by telephone or video interpretation services
- Lack of capacity to consent despite detailed explanation, ample opportunity to ask questions and time to consider options
- Transfer of care to another hospital out of area
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
IVF-conceived
Those who have conceived by IVF (for whatever indication); target 80 participants of which it is anticipated 20 would have conceived by frozen embryo transfer IVF.
|
Non-interventional cohort study
|
Spontaneously conceived
Those who have conceived spontaneously (within 12 months and without use of hormonal or other contraception); target 20 participants
|
Non-interventional cohort study
|
Ovulation induction-conceived
Those who have conceived by ovulation induction (after more than 12 months); target 20 participants.
|
Non-interventional cohort study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Recruitment feasibility: Number of referrals received
Time Frame: 3 years
|
3 years
|
Recruitment feasibility: Proportion of referrals eligible for recruitment
Time Frame: 3 years
|
3 years
|
Recruitment feasibility: Proportion of eligible individuals accepting recruitment
Time Frame: 3 years
|
3 years
|
Recruitment feasibility: Rate of recruitment
Time Frame: 3 years
|
3 years
|
Recruitment feasibility: Gestation at referral/first appointment
Time Frame: 3 years
|
3 years
|
Recruitment feasibility: Rate of consent to contact for future studies involving mother or child
Time Frame: 3 years
|
3 years
|
Protocol feasibility: Proportion of recruits completing all study visits
Time Frame: 3 years
|
3 years
|
Protocol feasibility: Average number of study visits required by each individual
Time Frame: 3 years
|
3 years
|
Protocol feasibility: Proportion of individuals accepting each type/gestation of investigation
Time Frame: 3 years
|
3 years
|
Protocol feasibility: Reliability of each type/gestation of investigation
Time Frame: 3 years
|
3 years
|
Protocol feasibility: Rate of withdrawal / loss to follow up
Time Frame: 3 years
|
3 years
|
Protocol feasibility: Proportion of recruits where fertility records could be accessed
Time Frame: 3 years
|
3 years
|
Missing data: Proportion of recruits scanned before 12 weeks' gestation
Time Frame: 3 years
|
3 years
|
Missing data: Proportion of missing data points for each type/gestation of investigation
Time Frame: 3 years
|
3 years
|
Missing data: Proportion of fertility treatment variables that could be ascertained from fertility records
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NHS001747 V2.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pregnancy Complications
-
The Cooper Health SystemRecruitingPregnancy,Neoplastic ComplicationsUnited States
-
Northwestern UniversityTerminatedPregnancy Related | Labor ComplicationUnited States
-
The George Washington University Biostatistics...Eunice Kennedy Shriver National Institute of Child Health and Human Development...Terminated
-
Jazz PharmaceuticalsRecruitingPregnancy | Pregnancy Complication | Maternal Complications | Birth Outcomes, AdverseUnited States
-
Oslo University HospitalRecruitingPregnancy Related | Labor Complication | Induced; BirthNorway
-
Thomas Jefferson UniversityCompleted
-
University Hospital Center of MartiniqueCompletedLabor Complication | CervixMartinique
-
Washington University School of MedicineUniversity of MichiganRecruiting
-
Egas Moniz - Cooperativa de Ensino Superior, CRLCompleted
-
PerspectumUniversity of Oxford; Fetal Medicine FoundationCompletedPregnancy Complications | Fetal Growth ComplicationsUnited Kingdom
Clinical Trials on Non-interventional cohort study
-
Vanderbilt University Medical CenterNational Institutes of Health (NIH); National Institute of General Medical...Active, not recruitingDelirium | Critical Illness | Cognitive Impairment | Trauma | Traumatic Brain Injury | ICU | Polytrauma | Alzheimer; Early OnsetUnited States
-
Universitätsklinikum Hamburg-EppendorfSandozUnknownPsoriasisDenmark, Spain, Germany, Poland
-
University Hospital, RouenRecruitingDyspepsia | Irritable Bowel Syndrome | Functional Constipation | Faecal IncontinenceFrance
-
Mayo ClinicRecruitingOropharyngeal Squamous Cell Carcinoma | Recurrent Oropharyngeal Squamous Cell Carcinoma | Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Stage III Oropharyngeal (p16-Negative)... and other conditionsUnited States
-
Mayo ClinicNational Cancer Institute (NCI); National Heart, Lung, and Blood Institute...RecruitingMalignant Solid Neoplasm | Hematopoietic and Lymphatic System NeoplasmUnited States
-
Mayo ClinicRecruitingStage 0a Bladder Cancer AJCC v8 | Stage 0is Bladder Cancer AJCC v8 | Stage I Bladder Cancer AJCC v8 | Stage IIIA Bladder Cancer AJCC v8 | Stage II Bladder Cancer AJCC v8United States
-
Mayo ClinicRecruitingClear Cell Renal Cell Carcinoma | Urothelial Carcinoma | Chromophobe Renal Cell Carcinoma | Papillary Renal Cell Carcinoma | Kidney Oncocytoma | Clear Cell Papillary Renal TumorUnited States
-
Mayo ClinicRecruitingProstate CarcinomaUnited States
-
Mayo ClinicNational Cancer Institute (NCI); National Institute for Biomedical Imaging...RecruitingProstate NeoplasmUnited States
-
University of WashingtonNational Cancer Institute (NCI)RecruitingRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal CarcinomaUnited States