Obesity Clinical Trial
— IVFOfficial title:
Effects of Fertility Drugs on Glucose Homeostasis and Other Metabolic Parameters on Patients Undergoing In Vitro Fertilization (IVF)
Verified date | July 2021 |
Source | University of Warwick |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United Arab Emirates | Fakih IVF | Dubai |
Lead Sponsor | Collaborator |
---|---|
University of Warwick | Fakih IVF Fertility Center, University of Sharjah |
United Arab Emirates,
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
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 |
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