Effects of Fertility Drugs on Glucose Homeostasis and Other Metabolic Parameters on Patients Undergoing In Vitro Fertilization (IVF)
Conditions: GDM, Insulin Resistance, Glucose Intolerance, PCOS, Obesity
Sponsor: University of Warwick

 
 
 
 
 
Effect of in vitro fertilisation (IVF) hormonal 
therapy on metabolic, endocrine and 
inflammatory status in IVF-conceived 
pregnancy 
 
NCT03426228 
 
 

 
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Chapter 1: Aim of the study and Objectives 
 
1. To explore the short-term effects of IVF hormonal therapy on maternal metabolic 
and inflammatory status, including:  
i. 
Risk of glucose intolerance and insulin resistance  
ii. 
Risk of other metabolic, endocrine and inflammatory disturbances (including lipid 
profile, gut microflora and thyroid function) 
2. To identify possible early predictors of GDM and other metabolic-related 
adverse outcomes in IVF-conceived pregnancies. 
 
 
Chapter 2: General Methods 
2.1. Ethics and Consents 
 
Approval to conduct the study was first granted by the University of Warwick’s 
Biomedical and Scientific Research Ethics Sub-Committee (BSREC). The study 
protocol was also reviewed by the two main health authorities in the UAE.  
 
2.2.  Study Design 
 
The presented study is a longitudinal quantitative cohort study (non-experimental), 
whereby blood samples were collected at different stages during IVF therapy.  
 
2.3. Study Setting 
 
The study took place at in three fertility clinics in the UAE. At the clinics, 
pre- and post-fertility treatments and in-house obstetric facilities are provided, 
including blood tests, scans, IVF procedures and in-house genetic testing. Most 
patients are followed up to the point of delivery.  
2.4. Study Population 
 

 
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 Pregnant group: received IVF therapy and tested positive for pregnancy 
at 4 weeks, and continued taking IVF hormonal therapy until 12 weeks of 
pregnancy. 
 
 Non-pregnant: received IVF therapy and tested negative for pregnancy at 
4 weeks, and stopped taking IVF hormonal therapy at that point. 
 
 
2.5. Sampling Technique 
 
The non-probability convenience sampling method was used to recruit participants 
for the study. Patients who were to start a fresh IVF treatment at any of the IVF 
Clinic branches and meeting the inclusion criteria were eligible to participate.  
 
2.6. Study Protocol  
 
After an overnight fast of 8 hours, there was collection of 10 ml of blood at four 
pre-defined time points during the IVF protocol: 
1. Phase 1– At baseline, egg maturation (starting IVF therapy) 
2. Phase 2 – Week 2 – Egg retrieval (OPU procedure)   
3. Phase 3 – Week 4 – At pregnancy test (β-HCG test) 
4. Phase 4 – Week 12 (one week after completing IVF hormonal 
therapy for pregnant group). 
 
2.7. Blood Tests 
 A trained nurse was in charge of measuring anthropometrics and clinical 
parameters (e.g. weight and blood pressure), in addition to taking fasting blood 
samples. The socio-demographics, medical and pregnancy histories of each patient 

 
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were recorded in their file. Blood tests were conducted at in the phlebotomy room 
and transferred to the lab (in-house) for analysis. Tests results were available on the 
clinics internal server at the end of each day.  
 
Table 1: List of Blood Tests at Each Stage of the Study 
 
 
Type of Tests 
Phase 1-
Baseline  
(Start IVF 
treatment) 
Phase 2-
Week 2 (Egg 
retrieval) 
Phase 3- 
Week 4 (β-
HCG test) 
Phase 4- 
Week 12 
(Final) 
Female reproductive 
hormones: FSH, LH, 
oestrogen, 
progesterone 
√ 
√ 
√ 
 
HbA1c 
√ 
 
 
√ 
Fasting glucose 
√ 
√ 
√ 
√ 
Fasting insulin 
√ 
√ 
√ 
√ 
TSH 
√ 
 
 
√ 
Fasting lipid profile 
√ 
 
 
√ 
Adiponectin 
√ 
 
 
√ 
LBP 
√ 
 
 
√ 
β-HCG pregnancy  
√ 
 
√ 
 
Body weight  
√ 
 
 
√ 
*Green highlight represents stage where non-pregnant vs. pregnant women groups were 
distinguished; FSH: follicle-stimulating hormones; LH: luteinizing hormone; HbA1c: 
glycated 
haemoglobin 
A1c; 
TSH: 
thyroid-stimulating 
hormone; 
LBP: 
lipopolysaccharide binding protein; β-HCG: beta-human chorionic gonadotrophin 
 
 
 
 
 
 

 
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Appendix 1. Anthropometrics and Medical History 
Questionnaire 
 
Effects of fertility drugs on glucose homeostasis, and 
other metabolic parameters on patients undergoing In 
Vitro Fertilisation (IVF) NCT03426228 
 
Subject Name: 
Telephone No: 
E-mail: 
 
 
Age 
 
Height 
 
Weight 
 
BMI 
 
Nationality 
 
Smoking 
 
Parity 
 
Past Illness and Surgeries 
 
 
 
 
 
Drug History 
 
 
 
 
 
Family History 
 
 
 
 
Women Health 
Cycle:          Regular                                                  Irregular 
 
 

 
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History of GDM: 
 
 
Previous IVF trials: 
 
 
 
 Blood Analysis 
Frequency 
Level/ Unit 
Type 
4 times 
 
Fasting glucose 
4 times 
 
Serum insulin 
Twice 
 
Lipid profile 
4 times 
 
FSH, LH 
4 times 
 
Oestrogen, Progesterone 
Once 
 
Beta-HCG 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Appendix 2. Participants Study Tests 
 
Effects of fertility drugs on glucose homeostasis, and 
other metabolic parameters on patients undergoing In 
Vitro Fertilisation (IVF) NCT03426228 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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