NCT03426228

In Vitro Fertilization Impact on Metabolic Parameters

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 344 (actual)
• Sponsor: University of Warwick · Academic / Other
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

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.

Conditions

• GDM
• Insulin Resistance
• Glucose Intolerance
• PCOS
• Obesity

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-02-15
• Primary completion: 2019-08-01
• Completion: 2020-01-05
• First posted: 2018-02-08
• Last updated: 2021-07-14
• Results posted: 2021-07-13

Locations

1 site across 1 country: United Arab Emirates