InfertilityNCT01448863
Metabolomic Embryo Profiles of Obese in Vitro Fertilization (IVF) Patients and Their Relationship With Polycystic Ovary Syndrome (PCO)
An observational study of Infertility and Obesity, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 38 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility, Obesity
- What is being tested?
- Culture medium metabolomic analysis
- How many people
- 28 participants
- Where
- 2 sitesSpain
- Study dates
- Oct 2011to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- < 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.
Trial locations and contacts
2 sites in 1 country.
About this study
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.
- Conditions
- Infertility, Obesity
- Being tested
- Culture medium metabolomic analysis
- Medical subject headings
- Infertility, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | Fertile women (egg-donors) Receives: Other: Culture medium metabolomic analysis | |
| WITH PCO | Obese women with Polycystic Ovarian Syndrome Receives: Other: Culture medium metabolomic analysis | |
| NO PCO | Obese women without Polycystic Ovarian Syndrome Receives: Other: Culture medium metabolomic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Bellver, Instituto Valenciano de Infertilidad, IVI VALENCIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448863
- Sponsor's protocol ID
- 1005-C-070-JB
- Status last verified
- Mar 2015
- First submitted
- 5 Oct 2011
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25935493
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomic Embryo Profiles of Obese in Vitro Fertilization (IVF) Patients and Their Relationship With Polycystic Ovary Syndrome (PCO)
- ClinicalTrials.gov ID
- NCT01448863
- Acronym / sponsor ID
- 1005-C-070-JB
- Conditions
- Infertility, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 7 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CONTROL | – | Other: Culture medium metabolomic analysisFertile women (egg-donors) |
| WITH PCO | – | Other: Culture medium metabolomic analysisObese women with Polycystic Ovarian Syndrome |
| NO PCO | – | Other: Culture medium metabolomic analysisObese women without Polycystic Ovarian Syndrome |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (8 listed)
- BMI > 30 kg/m2
- Age < 38 years old
- Non smokers
- First IVF cycle (groups 2 \& 3, not Control group)
- Normal uterus (seen by ultrasound)
Key exclusion criteria (3 listed)
- < 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culture medium metabolomic analysisDuring 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. | Other | CONTROL, NO PCO, WITH PCO |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
- Derived from this study: PubMed 25935493Bellver 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Obesity, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic profile of culture media of Day 3 embryos (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01448863, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2015.