NCT01448863

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2011

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

3 years

First QC Date

October 5, 2011

Last Update Submit

March 9, 2015

Conditions

InfertilityObesity

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

CONTROL

Fertile women (egg-donors)

Other: Culture medium metabolomic analysis

WITH PCO

Obese women with Polycystic Ovarian Syndrome

Other: Culture medium metabolomic analysis

NO PCO

Obese women without Polycystic Ovarian Syndrome

Other: Culture medium metabolomic analysis

Interventions

Culture medium metabolomic analysisOTHER

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.

CONTROLNO PCOWITH PCO

Eligibility Criteria

Age18 Years - 38 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • \< 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IVI Valencia

Valencia, Valencia, 46015, Spain

Location

IVI Valencia

Valencia, 46015, Spain

Location

Related Publications (1)

  • 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.

    PMID: 25935493DERIVED

MeSH Terms

Conditions

InfertilityObesity

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gynecologist IVI Valencia

Study Record Dates

First Submitted

October 5, 2011

First Posted

October 7, 2011

Study Start

October 1, 2011

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

March 10, 2015

Record last verified: 2015-03

Locations

ES(2)