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

Summary

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.

Conditions

• Preterm Birth
• Gestational Diabetes Mellitus (GDM)
• Gestational Hypertension

Interventions

OTHER

Since this is an observational study rather than an interventional study, the exposure type refers to all potential factors influencing pregnancy both before and during pregnancy

Since this is an observational study rather than an interventional study or clinical trial, the exposure type refers to all potential factors influencing pregnancy both before conception and during pregnancy. These exposures include: Lifestyle habits: Such as obesity, smoking and alcohol use before and during pregnancy. Sociodemographic factors: Such as age, residence, medical insurance. Medications: Any prescription, over-the-counter, or herbal medications used before or during pregnancy. Past medical history: Pre-existing medical conditions or illnesses, such as hypertension, diabetes, or autoimmune diseases, that could affect pregnancy. Past surgical history: Previous surgeries, especially those related to the reproductive system or any that may impact pregnancy outcomes. Previous pregnancies: Information about past pregnancies, including the number of full-term and preterm births, complications, and outcomes. Abortions: Any history of miscarriages

Sponsors & Collaborators

• American University of Beirut Medical Center

  collaborator OTHER

• Lebanese University

  lead OTHER

Principal Investigators

• Ghina Ghazeeri, Professor of OBGYN and REI · American University of Beirut Medical Center

• Amal Al Hajje, PhD in Clinical Pharmacy · Professor at the Lebanese University

• Roula Ajrouche, PhD in Epidemiology · Associate Professor at the Lebanese University

Eligibility

Min Age

20 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-09-01

Primary Completion

2024-09-30

Completion

2025-08-31

Countries

• Lebanon

Study Locations