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

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ClinicalTrials.gov Identifier: NCT01448863
Recruitment Status : Completed
First Posted : October 7, 2011
Last Update Posted : March 10, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Infertility Obesity Other: Culture medium metabolomic analysis

Study Design

Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : October 2011
Primary Completion Date : October 2014
Study Completion Date : October 2014

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U.S. FDA Resources

Groups and Cohorts

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.



Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01448863


Locations
Spain
IVI Valencia
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: October 7, 2011    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Infertility
Polycystic Ovary Syndrome
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases