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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor:
Information provided by (Responsible Party):
Jose Bellver, Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier:
NCT01448863
First received: October 5, 2011
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Infertility
Obesity
Other: Culture medium metabolomic analysis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Instituto Valenciano de Infertilidad, IVI VALENCIA:

Primary Outcome Measures:
  • Metabolic profile of culture media of Day 3 embryos [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 45
Study Start Date: October 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448863

Contacts
Contact: Jose Bellver, MDPhD 34 963050900 jose.bellver@ivi.es
Contact: Laura Privitera, MD 34 963050900 laura.privitera@ivi.es

Locations
Spain
IVI Valencia Recruiting
Valencia, Spain, 46015
Contact: Leslie Atkinson, Ma    34963050900    leslie.atkinson@ivi.es   
Principal Investigator: Jose Bellver, MDPhD         
IVI Valencia Recruiting
Valencia, Spain, 46015
Contact: Jose Bellver, MDPhD    963050900    jose.bellver@ivi.es   
Principal Investigator: jose Bellver, MDPhD         
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA
  More Information

No publications provided

Responsible Party: Jose Bellver, Gynecologist IVI Valencia, Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier: NCT01448863     History of Changes
Other Study ID Numbers: 1005-C-070-JB
Study First Received: October 5, 2011
Last Updated: July 28, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Infertility
Obesity
Polycystic Ovary Syndrome
Genital Diseases, Male
Genital Diseases, Female
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 29, 2014