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In Vitro Fertilization Impact on Metabolic Parameters (IVF)

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ClinicalTrials.gov Identifier: NCT03426228
Recruitment Status : Completed
First Posted : February 8, 2018
Results First Posted : July 13, 2021
Last Update Posted : July 14, 2021
Sponsor:
Collaborators:
Fakih IVF Fertility Center
University of Sharjah
Information provided by (Responsible Party):
Ayla Coussa, University of Warwick

Study Description
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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.

Condition or disease Intervention/treatment
GDM Insulin Resistance Glucose Intolerance PCOS Obesity Diagnostic Test: HbA1C

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 Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 344 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 9 Months
Official Title: Effects of Fertility Drugs on Glucose Homeostasis and Other Metabolic Parameters on Patients Undergoing In Vitro Fertilization (IVF)
Actual Study Start Date : February 15, 2018
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : January 5, 2020
Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: HbA1C

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

    1. At baseline (second day of the menstrual period)
    2. Triggering phase (post-egg retrieval procedure)
    3. Embryo transfer phase (post-transfer procedure)
    4. Week 4 (positive bHCG)

    4. 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

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   We will have two main groups of: Obese (BMI: 30-38) and non-obese (BMI: 18.5-29.9) women with the following criteria
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426228


Locations
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United Arab Emirates
Fakih IVF
Dubai, United Arab Emirates, 72960
Sponsors and Collaborators
University of Warwick
Fakih IVF Fertility Center
University of Sharjah
Investigators
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Principal Investigator: Ayla Coussa, Dietitian Fakih IVF Dubai
  Study Documents (Full-Text)

Documents provided by Ayla Coussa, University of Warwick:
Study Protocol  [PDF] December 15, 2019
Statistical Analysis Plan  [PDF] December 15, 2019
Informed Consent Form  [PDF] January 5, 2018

More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: Ayla Coussa, MSc., University of Warwick
ClinicalTrials.gov Identifier: NCT03426228    
Other Study ID Numbers: DSREC-11/2017_09
First Posted: February 8, 2018    Key Record Dates
Results First Posted: July 13, 2021
Last Update Posted: July 14, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: After conducting data collection and analysis the results will be available upon official publication.
Access Criteria: Data access requests will be reviewed by an external independent committee. Requestors will be required to sign a Data Access Agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ayla Coussa, University of Warwick:
IVF, Glucose Homeostasis, Metabolic Parameters
Additional relevant MeSH terms:
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Insulin Resistance
Glucose Intolerance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperglycemia
 Progesterone
Estrogens
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Progestins