Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:07 PM
Ignite Modification Date:
2025-12-24 @ 1:07 PM
NCT ID:
NCT04488861
Eligibility Criteria:
Inclusion Criteria:
1. Maternal age at enrolment of between 18 -39 years
2. (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
3. Antenatal care and delivery planned at St. Mary's Hospital, Manchester
4. Pregnant with one, live baby within the womb (known medically as a singleton, viable, intrauterine pregnancy) at the time of recruitment
5. Able to give informed consent, with or without the use of interpretation services
Exclusion Criteria:
1. Prisoners
2. Maternal age at enrolment younger than 18 or greater than or equal to 40 years.
3. 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.
4. Potential participant or partner not willing to consent to disclosure of fertility treatment records to the research team
5. Antenatal care and delivery planned at another hospital
6. Pre-existing maternal medical condition requiring specialist antenatal care beyond the scope of the SMART clinic, including BMI \> 35, pre-existing diabetes and hypertension
7. Miscarriage or fetal death in utero at the point of recruitment
8. Presence of detected clinically significant (as defined by clinician in charge of care) fetal abnormalities
9. Refusal of consent, including consent of the participant and any partner to access to fertility treatment records (as applicable)
10. Language barrier not overcome by telephone or video interpretation services
11. Lack of capacity to consent despite detailed explanation, ample opportunity to ask questions and time to consider options
12. Transfer of care to another hospital out of area
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
39 Years
Study:
NCT04488861
Study Brief:
Protocol Section:
NCT04488861