In Vitro Fertilization Impact on Metabolic Parameters (IVF)

U

University of Warwick

Status

Completed

Conditions

PCOS
GDM
Insulin Resistance
Obesity
Glucose Intolerance

Treatments

Diagnostic Test: HbA1C

Study type

Observational

Funder types

Other

Identifiers

NCT03426228
DSREC-11/2017_09

Details and patient eligibility

About

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.

Full 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.

Enrollment

344 patients

Sex

Female

Ages

18 to 39 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Trial documents
3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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