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NCT06836843Active, not recruiting

Evaluation of Maternal and Neonatal Outcomes in Women Are Conceived Through Assisted Reproductive Technology Compared to Other Fertility Treatments and Naturally Conceived Women: It is a Retrospective Cohort Study Conducted Over a 5-year Period at a Fertility Center in a Lebanese Hospital

Evaluation of Maternal and Neonatal Outcomes Among Lebanese Women Conceived Through Assisted Reproductive Technology

Source: ClinicalTrials.gov · Last updated 20 Feb 2025

Brief summary (registry, in English)

Background: The number of couples experiencing difficulties conceiving and seeking treatment for infertility has increased dramatically over time. Treatment options for infertility have evolved significantly over the past four decades, expanding to include assisted reproductive technologies (ART). However, the impact of ART on pregnancy outcomes remains unclear. Studies have shown that ART pregnancies are associated with a higher risk of maternal and neonatal adverse outcomes compared to those resulting from spontaneous conception. To this date, no comprehensive studies have been conducted in Lebanon to assess this association. Therefore, it is crucial to evaluate whether Lebanese women who conceive via ART are at higher risk for maternal and birth-related complications. Objective: The aim of this study is to evaluate maternal and neonatal outcomes among women who conceived through assisted reproductive technology (ART), compared to those who conceived via other fertility treatments or naturally, at Dr. Ghazeeri's clinic at the American University of Beirut Medical Center. Methods: Investigators propose to conduct an observational retrospective cohort study involving all pregnant women treated by Dr. Ghazeeri who delivered at the American University of Beirut Medical Center between 2018 and 2023. Pregnancies exposed to assisted reproductive technology (ART) or other fertility treatments will be matched to a group of spontaneous pregnancies based on propensity scores. The study has been initiated following approval from the Institutional Review Board (IRB) at the American University of Beirut Medical Center. Data analysis will be performed using SPSS version 26. Expected Results: If no associations are found between ART or other fertility treatments and an increased risk of maternal and neonatal outcomes, the results will provide reassurance for mothers seeking these treatments. However, if associations are identified, policymakers will need to establish comprehensive regulations outlining the appropriate use of these technologies. Additionally, these findings would lay the groundwork for obstetricians to implement closer monitoring and more careful management during pregnancy.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
1000 (estimated)
First submitted
10 Dec 2024
Start date
1 Sept 2023
Primary completion date
30 Sept 2024
Lead sponsor
Lebanese University
NCT number
NCT06836843

What you commit to

  • Study type: Observational
  • Planned participants: 1000
  • From 1 Sept 2023 to the primary completion date, 30 Sept 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • All subjects with history of severe chronic conditions before gestation such as, pre-existing cancer, heart diseases (coronary artery disease, arrhythmia, cardiac defects, ischemic stroke, venous thromboembolism, liver disease and/or kidney disease, history of nervous system disorders (seizures, depression).

Other

  • Subjects who started their follow-up after the 1st trimester (missing data before 12 weeks).
  • Subjects who undergone ART elsewhere
  • Subjects who lost to follow up during their pregnancies (missing data)
  • Moms who delivered outside the AUBMC hospital

Who the study is looking for

  • All pregnant ladies of Lebanese Nationality only who delivered at the American University of Beirut Medical Center (AUB-MC) between Nov 2018- Nov 2023
  • Pregnancies that were delivered at least 20 weeks of gestation (≥ 20 weeks)
  • All pregnant women who are in procreation age (20-50 years old)
  • For pregnant women by ART: only if ART is done at the AUB-MC
  • Subject's file being accessible for all the three trimesters
  • Subjects being followed up until delivery only at the AUB-MC
  • Subjects whom their baby or babies' records are available (it could be multiples)

Age in the registry: 20 years to 50 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Lebanese University
Coordinator of this site? Confirm its status
BeirutLebanonUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.