Metabolomic Embryo Profiles of Obese in Vitro Fertilization (IVF) Patients and Their Relationship With Polycystic Ovary Syndrome (PCO)

The present study aims to elucidate if there is a metabolomic profile alteration in the embryos of obese women in order to understand if the reduced implantation rate observed in these patients is directly related to this factor. Furthermore, the investigators seek to establish if there is any difference between obese women with Polycystic Ovary Syndrome (PCO) and without PCO. The investigators compare these metabolomic profile embryos with embryos of egg-donation programme.

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Key information

Conditions

Infertility Body Weight Genital Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases

Age range

18 year–38 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IVI Valencia, Valencia, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

BMI > 30 kg/m2
Age < 38 years old
Non smokers
First IVF cycle (groups 2 & 3, not Control group)
Normal uterus (seen by ultrasound)
normal basal hormonal profile(FSH,LH,estradiol,testosterone,androstenedione, insulin, SHBG, glucose, AMH)
Antral follicle count(> 5 FA for each ovary)
Menses every 25-35 days.

Exclusion criteria

< 5 or > 20 oocytes retrieved after stimulation cycle
estradiol >3000 pg/ml or progesterone > 1,5 ng/ml on the hCG day.
< 2 evolutive embryos in the culture medium.

Treatment and study plan

Culture medium metabolomic analysis

Other

During the embryo transfer at day 3, the investigators keep and freeze a small drop of the culture medium of each embryo transferred. Each drop of culture medium will have a volume of 40-50 microliters, before freezing is spun at 10.000 rps to avoid any possible contamination.

The frozen media culture is analyzed for the metabolomic profile.

Primary outcomes

Metabolic profile of culture media of Day 3 embryos

Time frame: 3 days

Determine differences in the metabolomic profile of the culture media of day 3 embryos, obtained after in vitro fertilization, according to the presence of obesity associated or not with polycystic ovary syndrome.

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Oct 7, 2011
Registry last updated: Mar 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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