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Completed

NCT Number: NCT03426228

In Vitro Fertilization Impact on Metabolic Parameters

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HBA1C

Diagnostic Test

After overnight fasting, 10 ml of blood will be collected at four different timings during the IVF protocol:

  • At baseline (second day of the menstrual period)
  • Triggering phase (post-egg retrieval procedure)
  • Embryo transfer phase (post-transfer procedure)
  • Week 4 (positive bHCG)
  • Week 8 of pregnancy

Other names: Lipid profile, Hormonal profile: FSH, LH, progesterone, estrogen,Beta-HCG, Serum Insulin level, Fasting Glucose level, Thyroid-Stimulating Hormone

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Warwick

Other

Collaborators

  • Fakih IVF Fertility Center
  • University of Sharjah

Registry information

Official study title

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

Acronym: IVF

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Feb 8, 2018
Registry last updated
Jul 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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