Clinical trial NCT03426228: In Vitro Fertilization Impact on Metabolic Parameters
Official title: Effects of Fertility Drugs on Glucose Homeostasis and Other Metabolic Parameters on Patients Undergoing In Vitro Fertilization (IVF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: GDM
Insulin Resistance
Glucose Intolerance
PCOS
Obesity
Keywords: IVF, Glucose Homeostasis, Metabolic Parameters
Lead sponsor: University of Warwick
Sponsor class: OTHER
Collaborators: name: Fakih IVF Fertility Center
name: University of Sharjah
First posted: 2018-02-08
Enrollment: 344
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Short-term Effect of Fertility Medications on Glucose Homeostasis and Insulin Resistance in Patients Undergoing IVF Treatment
timeFrame: 12 weeks of pregnancy
Secondary outcomes:
measure: Effect of Fertility Medications on Lipids Profile
timeFrame: 12 weeks of pregnancy
measure: Effect of Fertility Medications on Thyroid Function
timeFrame: 12 weeks of pregnancy
Other outcomes:
measure: Long-term Effect of Fertility Medications in Relation to Maternal and Fetal Outcomes
timeFrame: 9 months of pregnancy
Locations:
city: Dubai
country: United Arab Emirates
facility: Fakih IVF
Study officials:
affiliation: Fakih IVF Dubai
name: Ayla Coussa, Dietitian
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.