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| Name | Class |
|---|---|
| Fakih IVF Fertility Center | OTHER |
| University of Sharjah | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HbA1C | Diagnostic Test | After overnight fasting, 10 ml of blood will be collected at four different timings during the IVF protocol:
4. Week 8 of pregnancy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Any patient presenting to us for fresh IVF with the following:
Inclusion Criteria:
Exclusion Criteria:
We will have two main groups of: Obese (BMI: 30-38) and non-obese (BMI: 18.5-29.9) women with the following criteria
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.
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| Name | Affiliation | Role |
|---|---|---|
| Ayla Coussa, Dietitian | Fakih IVF Dubai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fakih IVF | Dubai | 72960 | United Arab Emirates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32578220 | Background | 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. | |
| 32215823 | Result | 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. |
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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.
After conducting data collection and analysis the results will be available upon official publication.
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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702screened -->673eligible to start IVF-->359 had embryo transfer -->191clinically confirmed pregnant+158 negative β-HCG+10 biochem pregnancy--> 64drop-outs+10 miscarriage--> Completed study and included in data: 158 pregnant+117 non-pregnant women
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-Pregnant | Negative BHCG at 4 weeks |
| FG001 | Pregnant | Positive BHCG at 4 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-Pregnant | Negative BHCG at 4 weeks |
| BG001 | Pregnant | Positive BHCG at 4 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | mg/dL | 12 weeks of pregnancy |
|
9 months
Study is observational and non-experimental. No invasive procedures were used.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-Pregnant | Negative BHCG at 4 weeks | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ayla Coussa | Fakih IVF | +971501403866 | A.coussa@warwick.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 15, 2019 | May 16, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 15, 2019 | May 16, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 5, 2018 | May 16, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D018149 | Glucose Intolerance |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | At 4 weeks, 191 were confirmed pregnant and 158 were non pregnant (negative BHCG). At 12weeks, 117 non-pregnants and 158 pregnants completed the study and analyzed (74 women excluded from data and attributed to drop-outs + those who travelled without completing the 12-week blood test). | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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) | Posted | Median | Inter-Quartile Range | mg/dL | 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. | Posted | Median | Inter-Quartile Range | μIU/mL | 12 weeks of pregnancy |
|
|
|
| Other Pre-specified | 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. | Not Posted | 9 months of pregnancy | Participants |
| 117 |
| 0 |
| 117 |
| 0 |
| 117 |
| EG001 | Pregnant | Positive BHCG at 4 weeks | 0 | 158 | 0 | 158 | 0 | 158 |
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| D006943 | Hyperglycemia |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |