Clinical trial NCT06836843: 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
Official title: Evaluation of Maternal and Neonatal Outcomes Among Lebanese Women Conceived Through Assisted Reproductive Technology
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Preterm Birth
Gestational Diabetes Mellitus (GDM)
Gestational Hypertension
Keywords: In vitro fertilization
IVF
Assisted reproductive technology
ART
neonatal outcome
neonatal complication
maternal outcome
maternal complication
pregnancy outcome
pregnancy complication
Intracytoplasmic sperm injection
spontaneous conception
fertility treatment
fertility management
Lead sponsor: Lebanese University
Sponsor class: OTHER
Collaborators: name: American University of Beirut Medical Center
First posted: 2025-02-20
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It is an observational retrospective cohort study on all pregnant women who delivered at the American University of Beirut Medical Center between 2018 and 2023. The patient characteristics will be extracted from the Epic electronic health record system at the hospital. Pregnancies exposed to ART or other fertility treatments will be matched to spontaneous pregnancies based on propensity scores.

Brief 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.

Detailed description: i. Study Design Investigators propose to conduct an observational retrospective cohort study on all pregnant women who delivered at Dr. Gahzeeri's clinic at the American University of Beirut Medical Center between 2018 and 2023. Investigators have obtained approval from the Institutional Review Board (IRB) at AUB, which is valid until August 2025.

ii. Sample Size: As this is a retrospective cohort study, the sample size will be determined by the number of participants who meet the inclusion criteria.

iii. Population The patient characteristics will be extracted from the Epic electronic health record system at the hospital. Pregnancies exposed to ART or other fertility treatments will be matched to spontaneous pregnancies based on propensity scores

In this study, the subjects will be divided into two groups:

1. Exposed group:

   * Group One (ART group): pregnancies conceived via either IVF/ICSI and/or Assisted hatching (AH) and/or Pre-implantation genetic testing (PGT).
   * Group one will also be subdivided into fresh embryo transfer (ET) and frozen embryo transfer (FET) subgroups based on the type of embryo transfer method used.
   * Group Two (Non-ART group): pregnancies conceived through ovulation induction (OI) and/or intrauterine insemination (IUI) and/or corrective gynecological surgery.
2. Non-exposed group: spontaneous pregnancies, defined as pregnancies resulting from natural conception.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

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

Primary outcomes:
measure: Percentage of Pregnant Women with Gestational Diabetes Mellitus (GDM) in the Exposed Group versus Non-Exposed Group
timeFrame: 24-28 weeks of gestation
measure: Percentage of Pregnant Women with Gestational Hypertension in the Exposed Group versus the Non-Exposed Group
timeFrame: from 20 weeks + 1 day to 40 weeks of gestation
measure: Percentage of Babies Born Preterm to Women in the Exposed Group versus Non-Exposed Group
timeFrame: Before 37 weeks of gestation
measure: Percentage of Babies Born Small for Gestational Age to Women in the Exposed Group versus Non-Exposed Group
timeFrame: day one of birth
measure: Percentage of Babies Born Large for Gestational Age to Women in the Exposed Group versus Non-Exposed Group
timeFrame: day one of birth
Secondary outcomes:
measure: Percentage of Pregnant Women with Polyhydramnios in the Exposed Group versus Non-Exposed Group
timeFrame: During 40 weeks of gestation
measure: Percentage of Pregnant Women with Oligohydramnios in the Exposed Group versus Non-Exposed Group
timeFrame: During 40 weeks of gestation
Other outcomes:
measure: Percentage of Pregnant Women with Hypothyroidism in the Exposed Group versus Non-Exposed Group
timeFrame: During 40 weeks of gestation
measure: Percentage of Pregnant Women with Hyperthyroidism in the Exposed Group versus Non-Exposed Group
timeFrame: During 40 weeks of gestation
Locations:
city: Beirut
country: Lebanon
facility: Lebanese University
state: Hadath
Study officials:
affiliation: American University of Beirut Medical Center
name: Ghina Ghazeeri, Professor of OBGYN and REI
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor at the Lebanese University
name: Amal Al Hajje, PhD in Clinical Pharmacy
role: STUDY_DIRECTOR
affiliation: Associate Professor at the Lebanese University
name: Roula Ajrouche, PhD in Epidemiology
role: STUDY_DIRECTOR
References:
citation: Graham ME, Jelin A, Hoon AH Jr, Wilms Floet AM, Levey E, Graham EM. Assisted reproductive technology: Short- and long-term outcomes. Dev Med Child Neurol. 2023 Jan;65(1):38-49. doi: 10.1111/dmcn.15332. Epub 2022 Jul 18.
citation: Vermey BG, Buchanan A, Chambers GM, Kolibianakis EM, Bosdou J, Chapman MG, Venetis CA. Are singleton pregnancies after assisted reproduction technology (ART) associated with a higher risk of placental anomalies compared with non-ART singleton pregnancies? A systematic review and meta-analysis. BJOG. 2019 Jan;126(2):209-218. doi: 10.1111/1471-0528.15227. Epub 2018 May 8.
citation: Chih HJ, Elias FTS, Gaudet L, Velez MP. Assisted reproductive technology and hypertensive disorders of pregnancy: systematic review and meta-analyses. BMC Pregnancy Childbirth. 2021 Jun 28;21(1):449. doi: 10.1186/s12884-021-03938-8.
citation: Bosdou JK, Anagnostis P, Goulis DG, Lainas GT, Tarlatzis BC, Grimbizis GF, Kolibianakis EM. Risk of gestational diabetes mellitus in women achieving singleton pregnancy spontaneously or after ART: a systematic review and meta-analysis. Hum Reprod Update. 2020 Jun 18;26(4):514-544. doi: 10.1093/humupd/dmaa011.
citation: Qin J, Liu X, Sheng X, Wang H, Gao S. Assisted reproductive technology and the risk of pregnancy-related complications and adverse pregnancy outcomes in singleton pregnancies: a meta-analysis of cohort studies. Fertil Steril. 2016 Jan;105(1):73-85.e1-6. doi: 10.1016/j.fertnstert.2015.09.007. Epub 2015 Oct 9.