Examining how assisted reproductive technologies affect pregnancy outcomes
Association of Assisted Reproductive Technologies Parameters With the Perinatal Outcome in Singleton and Multiple Pregnancies: A Multicenter Prospective Cohort Study
This study is trying to see if different assisted reproductive technologies affect the health of pregnancies and if they are linked to risks like growth problems or stillbirth.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12084 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Aristotle University Of Thessaloniki Academic / other |
| Locations | 6 sites (Pleven and 5 other locations) |
| Trial ID | NCT06918236 on ClinicalTrials.gov |
What this trial studies
This prospective cohort study aims to investigate the relationship between various parameters of assisted reproductive technologies (ART) and perinatal outcomes in both singleton and multiple pregnancies. Researchers will assess whether ART pregnancies are linked to higher risks of conditions such as fetal growth restriction, preeclampsia, and stillbirth, while also examining potential placental and umbilical cord abnormalities. The study will adjust for confounding factors like maternal age and BMI, and will analyze outcomes based on specific ART techniques and protocols. By clarifying these associations, the study seeks to enhance clinical care and counseling for couples considering ART.
Who should consider this trial
Good fit: Ideal candidates include individuals with singleton or multiple pregnancies who have a live fetus between 11 weeks and 13 weeks of gestation.
Not a fit: Patients with known genetic anomalies or major fetal defects diagnosed before or after birth may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved clinical practices and counseling for couples undergoing assisted reproductive technologies.
How similar studies have performed: Previous studies have explored ART outcomes, but this study's comprehensive approach to examining specific ART parameters in relation to adverse outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Singleton or multiple pregnancies * Live fetus between 11 weeks plus 0 days and 13 weeks plus 6 days of gestation Exclusion Criteria * Known genetic anomalies diagnosed before or after birth * Major fetal defects diagnosed before or after birth, such as acrania, holoprosencephaly, megacystis, exomphalos, congenital heart defects
Where this trial is running
Pleven and 5 other locations
- University Hospital of Pleven — Pleven, Bulgaria (Not_yet_recruiting)
- Aristotle University of Thessaloniki — Thessaloniki, Central Macedonia, Greece (Recruiting)
- Complejo Hospitalario Universitario de Canarias — Santa Cruz de Tenerife, Canary Islands, Spain (Not_yet_recruiting)
- Universidad Francisco de Vitoria — Madrid, Spain (Not_yet_recruiting)
- Hospital Universitario de Torrejón — Madrid, Spain (Not_yet_recruiting)
- Hospital Clínico Universitario "virgen de la Arrixaca" — Murcia, Spain (Not_yet_recruiting)
Study contacts
- Study coordinator: Themistoklis Dagklis
- Email: dagklis@auth.gr
- Phone: +302313312120
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.