In Vitro Fertilization Impact on Metabolic Parameters

Completed

• Conditions: Obesity; GDM; Glucose Intolerance; PCOS; Insulin Resistance

• Registration Number: NCT03426228
• Lead Sponsor: University of Warwick

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-01-03
• Study First Submitted QC: 2018-02-01
• Study First Posted: 2018-02-08
• Study Start: 2018-02-15
• Primary Completion: 2019-08-01
• Study Completion: 2020-01-05
• Results First Submitted: 2020-11-03
• Results First Submitted QC: 2021-06-20
• Status Verified: 2021-07
• Results First Posted: 2021-07-13
• Last Update Submitted: 2021-07-13
• Last Update Posted: 2021-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 344

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Short-term Effect of Fertility Medications on Glucose Homeostasis and Insulin Resistance in Patients Undergoing IVF Treatment	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.

Secondary Outcome Measures

Name	Time	Method
Effect of Fertility Medications on Thyroid Function	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.
Effect of Fertility Medications on Lipids Profile	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)

Trial Locations

Locations (1)

Fakih IVF; 🇦🇪 Dubai, United Arab Emirates