In Vitro Fertilization Impact on Metabolic Parameters (IVF)

July 13, 2021 updated by: Ayla Coussa, University of Warwick

Effects of Fertility Drugs on Glucose Homeostasis and Other Metabolic Parameters on Patients Undergoing In Vitro Fertilization (IVF)

A quantitative prospective cohort study will be conducted, where blood samples will be collected at different timings during the IVF protocol, to assess the impact of fertility medications on metabolic parameters of patients undergoing IVF treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Numerous factors predispose women to develop pregnancy-related complications, these include gestational diabetes (GDM), pre-pregnancy obesity, advanced maternal age (> 35 years) and gestational age, abnormal weight gain during pregnancy, family history of diabetes, PCOS and low parity. Evidenced-based studies reported that women with PCOS have a significantly higher risk of developing GDM compared with women without PCOS, independently of the obesity factor; this risk is higher when both factors coexist.

Given the known effect of reproductive hormones on weight-gain, controversies still exist on whether ART predispose women to more adverse obstetric outcomes compared to normal pregnancy. ART describes different procedures to help women become pregnant, with In Vitro Fertilization (IVF) being the most commonly performed. It has been demonstrated that IVF is associated with glucose intolerance in mice and it will be interesting to determine whether this physiologic phenomenon is also altered by IVF medication (such as estrogen and progesterone) in humans. While some studies reported that singleton pregnancies conceived by ART (IVF or ovulation induction) were strongly associated with GDM compared to spontaneous conceptions, other studies did not find significant differences in the risk of GDM. Increased GDM risk presented with IVF can be associated with prenatal obesity or secondary to maternal PCOS condition. The former studies did not specify the body mass index (BMI) and the medical history of participants undergoing IVF, such as the presence of PCOS. Due to limited available data, we still cannot distinguish whether these adverse pregnancy outcomes are due to the pre-existing conditions such as PCOS, or are secondary to the IVF therapy itself.

Study Type

Observational

Enrollment (Actual)

344

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

A convenience sample from adult women of < 39 years of age undergoing fresh IVF treatment at Fakih IVF Clinic in Dubai will be chosen. Participants who will fulfill the inclusion criteria will be recruited.

Description

Any patient presenting to us for fresh IVF with the following:

Inclusion Criteria:

  • Presenting with or without PCOS
  • Presenting with structural or mechanical infertility, such as fallopian tube obstruction, endometriosis, fibroids
  • Presenting with male factor
  • Presenting with or without insulin resistance
  • Combination of more than one of the listed above criteria

Exclusion Criteria:

  • Pre-diabetes or diabetes patients (confirmed by impaired or abnormal OGTT)
  • Age above 39 years of age
  • Taking glucose-lowering meds, such as metformin or janumet.
  • Taking corticosteroids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-term Effect of Fertility Medications on Glucose Homeostasis and Insulin Resistance in Patients Undergoing IVF Treatment
Time Frame: 12 weeks of pregnancy
Participants who experience an abnormal increase in fasting glucose (>110) and A1C (>5.7) will be identified post-treatment. Also, for those previously known to be insulin-resistant, HOMA ratio will help identifying whether the treatment worsens or has no effect on their insulin resistance state.
12 weeks of pregnancy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Fertility Medications on Lipids Profile
Time Frame: 12 weeks of pregnancy
Lipid profile will be measured before and after treatment; participants experiencing hypercholesterolemia post-treatment will be consulted by a dietitian to help them better manage the condition during their pregnancy (total chol, LDL and triglycerides)
12 weeks of pregnancy
Effect of Fertility Medications on Thyroid Function
Time Frame: 12 weeks of pregnancy
TSH level will be measured pre- and post-IVF. Early diagnosis of thyroid dysfunction will be closely monitored with frequent repetitions of blood test, especially during the first trimester.
12 weeks of pregnancy

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term Effect of Fertility Medications in Relation to Maternal and Fetal Outcomes
Time Frame: 9 months of pregnancy
Early management and/control of metabolic-related adverse outcomes in relation to IVF treatment will prevent GDM by for instance glucophage administration or regular blood test of TSH for participants reported to be at higher risk of thyroid dysfunction.
9 months of pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Warwick

Collaborators

University of Sharjah
Fakih IVF Fertility Center

Investigators

  • Principal Investigator: Ayla Coussa, Dietitian, Fakih IVF Dubai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 15, 2018

Primary Completion (ACTUAL)

August 1, 2019

Study Completion (ACTUAL)

January 5, 2020

Study Registration Dates

First Submitted

January 3, 2018

First Submitted That Met QC Criteria

February 1, 2018

First Posted (ACTUAL)

February 8, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 14, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSREC-11/2017_09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All the study information will be kept confidential. Patients' names will not be identified in any publication or presentation of the study findings. Only groups' results will be reported.

IPD Sharing Time Frame

After conducting data collection and analysis the results will be available upon official publication.

IPD Sharing Access Criteria

Data access requests will be reviewed by an external independent committee. Requestors will be required to sign a Data Access Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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