In Vitro Fertilization Impact on Metabolic Parameters

Obesity Clinical Trial

— IVF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03426228
• Other study ID #: DSREC-11/2017_09
• Status: Completed
• Start date: February 15, 2018
• Est. completion date: January 5, 2020

Study information

• Verified date: July 2021
• Source: University of Warwick
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 344
• Est. completion date: January 5, 2020
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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 pregnancy

Locations

Country	Name	City	State
United Arab Emirates	Fakih IVF	Dubai

Sponsors (3)

Lead Sponsor	Collaborator
University of Warwick	Fakih IVF Fertility Center, University of Sharjah

Country where clinical trial is conducted

United Arab Emirates, 

References & Publications (2)

Coussa A, Hasan HA, Barber TM. Effects of in vitro fertilization (IVF) therapies on metabolic, endocrine and inflammatory status in IVF-conceived pregnancy. Clin Endocrinol (Oxf). 2020 Dec;93(6):705-712. doi: 10.1111/cen.14270. Epub 2020 Jul 9. — View Citation

Coussa A, Hasan HA, Barber TM. Impact of contraception and IVF hormones on metabolic, endocrine, and inflammatory status. J Assist Reprod Genet. 2020 Jun;37(6):1267-1272. doi: 10.1007/s10815-020-01756-z. Epub 2020 Mar 25. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Long-term Effect of Fertility Medications in Relation to Maternal and Fetal Outcomes	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.	9 months of pregnancy
Primary	Short-term Effect of Fertility Medications on Glucose Homeostasis and Insulin Resistance in Patients Undergoing IVF Treatment	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.	12 weeks of pregnancy
Secondary	Effect of Fertility Medications on Lipids Profile	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)	12 weeks of pregnancy
Secondary	Effect of Fertility Medications on Thyroid Function	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.	12 weeks of pregnancy