drugset / Trial / NCT02653092

Reprometabolic Syndrome Mediates Subfertility in Obesity

NCT02653092

Non-randomizedParallel-groupOpen-labelBasic science

Summary

Obesity plays an adverse role at every stage of conception and pregnancy and mounting evidence implicates relative hypogonadotropic hypogonadism, and reduced menstrual cycle hormone secretion as likely contributors to the subfertility phenotype and possible contributors to complications of pregnancy and the developmental origin of adult diseases such as diabetes and cardiovascular disease. This study will be the first comprehensive investigation to tie together the patterns of hyperinsulinemia, hyperlipidemia and inflammation, characteristic of obesity and obesity-caused relative hypogonadotropic hypogonadotropism and its potential adverse reproductive outcomes. The investigators findings will be used to inform a subsequent clinical intervention to optimize reproductive outcomes for obese women and their offspring.

Timeline

Start
2016-06
Primary completion
2023-12-11
Completion
2026-12-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Gonadorelin Protein / enzyme biologic 75 unknown
Subject Insulin Protein / enzyme biologic
Comparator Intralipid Other / unclassified
Background Dextrose Unknown
Background Heparin Other / unclassified