In Vitro Fertilization Impact on Metabolic Parameters (IVF)
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|ClinicalTrials.gov Identifier: NCT03426228|
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : May 9, 2019
|Condition or disease||Intervention/treatment|
|GDM Insulin Resistance Glucose Intolerance PCOS Obesity||Diagnostic Test: HbA1C|
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 [Patient Registry]|
|Estimated Enrollment :||192 participants|
|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|
|Estimated Primary Completion Date :||September 1, 2019|
|Estimated Study Completion Date :||December 31, 2019|
- Diagnostic Test: HbA1C
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)
4. Week 8 of pregnancyOther Names:
- Lipid profile
- Hormonal profile: FSH, LH, progesterone, estrogen,Beta-HCG
- Serum Insulin level
- Fasting Glucose level
- Thyroid-Stimulating Hormone
- Short-term effect of fertility medications on glucose homeostasis and insulin resistance in patients undergoing IVF treatment [ Time Frame: 8 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.
- Effect of fertility medications on other metabolic parameters [ Time Frame: 8 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)
- Effect of fertility medications on thyroid function [ Time Frame: 8 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.
- 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.
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
|Contact: Thomas Barber, MD||00447808503749||T.Barber@warwick.ac.uk|
|Contact: Haydar Hasan, MDfirstname.lastname@example.org|
|United Arab Emirates|
|Dubai, United Arab Emirates, 72960|
|Contact: Ayla Coussa, Dietitian 00971 4 349 7600 ext 162 email@example.com|
|Contact: Michael Fakih, MD 00971 4 349 7600 ext 117 firstname.lastname@example.org|
|Principal Investigator:||Ayla Coussa, Dietitian||Fakih IVF Dubai|