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

NCT ID: NCT01448863

Last Updated: 2015-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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CONTROL

Fertile women (egg-donors)

Culture medium metabolomic analysis

Intervention Type 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.

WITH PCO

Obese women with Polycystic Ovarian Syndrome

Culture medium metabolomic analysis

Intervention Type 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.

NO PCO

Obese women without Polycystic Ovarian Syndrome

Culture medium metabolomic analysis

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role lead

Responsible Party

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Jose Bellver

Gynecologist IVI Valencia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IVI Valencia

Valencia, Valencia, Spain

Site Status

IVI Valencia

Valencia, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 25935493 (View on PubMed)

Other Identifiers

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1005-C-070-JB

Identifier Type: -

Identifier Source: org_study_id

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