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NCT03426228: IVF

In Vitro Fertilization Impact on Metabolic Parameters

Completed Results posted Last updated 14 July 2021
What this trial tests

trial testing HbA1C in GDM in 344 participants. Completed in 5 January 2020.

Timeline
15 February 2018
Primary endpoint
1 August 2019
5 January 2020

Quick facts

Lead sponsorUniversity of Warwick
StatusCompleted
Study typeOBSERVATIONAL
Enrollment344
Start date15 February 2018
Primary completion1 August 2019
Estimated completion5 January 2020
Sites1 location across United Arab Emirates

Drugs / interventions tested

Conditions studied

Sponsor

University of Warwick

Who can join

Adults 18 to 39, female only, with GDM or Insulin Resistance. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Short-term Effect of Fertility Medications on Glucose Homeostasis and Insulin Resistance in Patients Undergoing IVF Treatment Primary · 12 weeks of pregnancy

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.

Glucose, fasting
GroupValue95% CI
Non-Pregnant87.6279.3 – 95.9
Pregnant82.1975 – 89.4
Insulin, fasting
GroupValue95% CI
Non-Pregnant9.374.00 – 14.8
Pregnant9.452.5 – 16.4
Effect of Fertility Medications on Lipids Profile Secondary · 12 weeks of pregnancy

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)

GroupValue95% CI
Pregnant199.5155.15 – 243.9
Non-pregnant174.9126.9 – 222.9
Effect of Fertility Medications on Thyroid Function Secondary · 12 weeks of pregnancy

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.

GroupValue95% CI
Pregnant1.360.26 – 2.46
Non-pregnant1.800.75 – 2.85

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of HbA1C

Trials testing the same drug.

Other recruiting trials for GDM

Currently open trials in the same condition.

Other University of Warwick trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03426228.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing