The START Clinic: a Feasibility Study

NCT04488861 | Active Not Recruiting

• 1 other identifier: NHS001747 V2.0
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy Complications; IVF; Fetal Growth Retardation; Preeclampsia; Placenta Diseases

Outcome Measures

Primary Outcomes (15)

• Recruitment feasibility: Number of referrals received

  3 years

• Recruitment feasibility: Proportion of referrals eligible for recruitment

  3 years

• Recruitment feasibility: Proportion of eligible individuals accepting recruitment

  3 years

• Recruitment feasibility: Rate of recruitment

  3 years

• Recruitment feasibility: Gestation at referral/first appointment

  3 years

• Recruitment feasibility: Rate of consent to contact for future studies involving mother or child

  3 years

• Protocol feasibility: Proportion of recruits completing all study visits

  3 years

• Protocol feasibility: Average number of study visits required by each individual

  3 years

• Protocol feasibility: Proportion of individuals accepting each type/gestation of investigation

  3 years

• Protocol feasibility: Reliability of each type/gestation of investigation

  3 years

• Protocol feasibility: Rate of withdrawal / loss to follow up

  3 years

• Protocol feasibility: Proportion of recruits where fertility records could be accessed

  3 years

• Missing data: Proportion of recruits scanned before 12 weeks' gestation

  3 years

• Missing data: Proportion of missing data points for each type/gestation of investigation

  3 years

• Missing data: Proportion of fertility treatment variables that could be ascertained from fertility records

  3 years

Study Arms (3)

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.

Other: 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

Other: Non-interventional cohort study

Ovulation induction-conceived

Those who have conceived by ovulation induction (after more than 12 months); target 20 participants.

Other: Non-interventional cohort study

Interventions

Non-interventional cohort study OTHER

Non-interventional cohort study

IVF-conceived; Ovulation induction-conceived; Spontaneously conceived

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant individuals, meeting the inclusion and exclusion criteria, registering for antenatal care and delivery at Manchester University Hospitals NHS Foundation Trust.

You may qualify if:

• 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

You may not qualify if:

• Prisoners
• Maternal age at enrolment younger than 18 or greater than or equal to 40 years.
• 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

Sponsors & Collaborators

• Manchester Academic Health Science Centre: lead
• Academy of Medical Sciences, UK: collaborator
• Erasmus Medical Center: collaborator
• Tommy's: collaborator

Study Sites (1)

Maternal and Fetal Health Research Centre, University of Manchester

Manchester, M13 9WL, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Maternal blood (pre-delivery) Maternal urine Maternal saliva Maternal hair Placental tissue Umbilical cord blood

MeSH Terms

Conditions

Pregnancy Complications; Fetal Growth Retardation; Pre-Eclampsia; Placenta Diseases

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension, Pregnancy-Induced

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NIHR Academic Clinical Lecturer in Obstetrics

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 28, 2020
• Study Start: March 15, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 3 to 5 years
• Access Criteria: Open access for completely anonymised data with appropriate metadata for interpretation. Applications to access pseudonymised data may be considered in writing to the principal investigator, subject to appropriate local approvals and a data management plan that conforms to the requirements of the University of Manchester.

Locations

GB (1)