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.

Study Overview

• Status: Completed
• Conditions: Obesity; Infertility
• Intervention / Treatment: Other: Culture medium metabolomic analysis

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46015
    • IVI Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

45 women divided into three groups: A)15 Obese women without Polycystic Ovarian Syndrome: BMI > 30 kg/m2 , age < 38 years old, normal basal hormonal profile (FSH, LH, estradiol, testosterone, androstenedione, insulin, SHBG, glucose, AMH, and antral follicle count(> 5 FA for each ovary), menses every 25-35 days.

B)15 Obese women with Polycystic Ovarian Syndrome: BMI > 30 kg/m2, age < 38 years old, basal hormonal profile with or without hyperandrogenism and ultrasound ovary aspect of PCO.

C)15 Fertile women (egg-donors): BMI 20-24.9 kg/m2. All the patients have normal uterine conditions, are not smokers, without endometriosis or hidrosalpinx. All the male partners have sperm parameters: count(> 5 mill/ml,15% motility,> 0% normal morphology)and BMI < 28 kg/m2.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CONTROL; Fertile women (egg-donors)	Other: Culture medium metabolomic analysis; 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.
WITH PCO; Obese women with Polycystic Ovarian Syndrome	Other: Culture medium metabolomic analysis; 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.
NO PCO; Obese women without Polycystic Ovarian Syndrome	Other: Culture medium metabolomic analysis; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic profile of culture media of Day 3 embryos	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.	3 days

Collaborators and Investigators

• Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

Publications and helpful links

General Publications

• Bellver J, De Los Santos MJ, Alama P, Castello D, Privitera L, Galliano D, Labarta E, Vidal C, Pellicer A, Dominguez F. Day-3 embryo metabolomics in the spent culture media is altered in obese women undergoing in vitro fertilization. Fertil Steril. 2015 Jun;103(6):1407-15.e1. doi: 10.1016/j.fertnstert.2015.03.015. Epub 2015 Apr 29.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: October 5, 2011
• First Submitted That Met QC Criteria: October 6, 2011
• First Posted (Estimate): October 7, 2011

Study Record Updates

• Last Update Posted (Estimate): March 10, 2015
• Last Update Submitted That Met QC Criteria: March 9, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 1005-C-070-JB