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

NCT06836843 | Active Not Recruiting DMC

• 1 other identifier: BIO-2023-0200
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (5)

• Percentage of Pregnant Women with Gestational Diabetes Mellitus (GDM) in the Exposed Group versus Non-Exposed Group

  GDM will be diagnosed using standardized glucose screening tests; Oral Glucose Tolerance Test (OGTT) between 24 and 28 weeks of gestation. One-hour OGTT (after drinking a 50g glucose solution): Different cut-off thresholds are used for the 50-g glucose tolerance screening to be considered an abnormal result, including ≥130 mg/dL , ≥135 mg/dL, and ≥140 mg/dL. * Possible Gestational Diabetes (possible diagnosis if ≥140 mg/dL); and here the patient requires a confirmatory diagnosis which is the three-hours OGTT (after drinking 100g glucose solution): * Normal \<140 mg/dL * Gestational Diabetes ≥140 mg/dL

  24-28 weeks of gestation

• Percentage of Pregnant Women with Gestational Hypertension in the Exposed Group versus the Non-Exposed Group

  Gestational hypertension is confirmed when blood pressure greater than or equal to 140mmHg systolic or 90mmHg diastolic on 2 separate occasions at least 4 hours apart after 20 weeks of pregnancy when previous blood pressure was normal

  from 20 weeks + 1 day to 40 weeks of gestation

• Percentage of Babies Born Preterm to Women in the Exposed Group versus Non-Exposed Group

  Preterm is defined as babies born alive before 37 weeks of pregnancy are completed.

  Before 37 weeks of gestation

• Percentage of Babies Born Small for Gestational Age to Women in the Exposed Group versus Non-Exposed Group

  Infants with a birth weight below the 10th percentile for their gestational age.

  day one of birth

• Percentage of Babies Born Large for Gestational Age to Women in the Exposed Group versus Non-Exposed Group

  Infants with a birth weight above the 90th percentile for their gestational age

  day one of birth

Secondary Outcomes (2)

• Percentage of Pregnant Women with Polyhydramnios in the Exposed Group versus Non-Exposed Group

  During 40 weeks of gestation

• Percentage of Pregnant Women with Oligohydramnios in the Exposed Group versus Non-Exposed Group

  During 40 weeks of gestation

Other Outcomes (2)

• Percentage of Pregnant Women with Hypothyroidism in the Exposed Group versus Non-Exposed Group

  During 40 weeks of gestation

• Percentage of Pregnant Women with Hyperthyroidism in the Exposed Group versus Non-Exposed Group

  During 40 weeks of gestation

Study Arms (2)

Exposed Group

The exposed group is subdivided into: Group one (Assisted Reproductive Technology group): pregnancies conceived via either in-vitro fertilization (IVF) with or without intracytoplasmic sperm injection (ICSI) with or without assisted hatching (AH) with or without pre-implantation genetic testing (PGT). Group two (Non-Assisted Reproductive Technology Group): pregnancies conceived through ovulation induction (OI) and/or intrauterine insemination (IUI) and/or corrective gynecological surgery.

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

Non-exposed Group

Spontaneous pregnancies, defined as pregnancies resulting from natural conception.

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

Interventions

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 OTHER

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

Exposed Group; Non-exposed Group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: The eligibility for participation in this study is restricted to individuals who identify as female and are currently pregnant.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Lebanese University: lead
• American University of Beirut Medical Center: collaborator

Study Sites (1)

Lebanese University

Beirut, Hadath, Lebanon

Location

Related Publications (5)

• 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.

  PMID: 35851656 BACKGROUND

• 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.

  PMID: 29740927 BACKGROUND

• 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.

  PMID: 34182957 BACKGROUND

• 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.

  PMID: 32441298 BACKGROUND

• 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.

  PMID: 26453266 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Diabetes, Gestational; Hypertension, Pregnancy-Induced; Pregnancy Complications

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ghina Ghazeeri, Professor of OBGYN and REI

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

• Amal Al Hajje, PhD in Clinical Pharmacy

  Professor at the Lebanese University

  STUDY DIRECTOR

• Roula Ajrouche, PhD in Epidemiology

  Associate Professor at the Lebanese University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: February 20, 2025
• Study Start: September 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: August 1, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

LE (1)