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

Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01448863
• Other study ID #: 1005-C-070-JB
• Status: Completed
• Phase: N/A
• First received: October 5, 2011
• Last updated: March 9, 2015
• Start date: October 2011
• Est. completion date: October 2014

Study information

• Verified date: March 2015
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 38 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility
• Obesity
• Polycystic Ovary Syndrome

Intervention

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.

Locations

Country	Name	City	State
Spain	IVI Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No