Status:
ACTIVE_NOT_RECRUITING
The START Clinic: a Feasibility Study
Lead Sponsor:
Manchester Academic Health Science Centre
Collaborating Sponsors:
Academy of Medical Sciences, UK
Erasmus Medical Center
Conditions:
Pregnancy Complications
IVF
Eligibility:
FEMALE
18-39 years
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-conceive...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04488861
Start Date
March 15 2021
End Date
September 1 2024
Last Update
March 12 2024
Active Locations (1)
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1
Maternal and Fetal Health Research Centre, University of Manchester
Manchester, United Kingdom, M13 9WL