PregnancyNCT00469807
Ghrelin Levels in Early IVF Pregnancies
An observational study of Pregnancy, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
In this study, we have assessed the potential prognostic value for gestational outcome of maternal ghrelin levels at very early stages of IVF pregnancies. In addition, ghrelin responses to meal intake were explored at early gestation. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- How many people
- Not given
- Where
- 1 siteSpain
- Study dates
- Jun 2004to May 2007
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients undergoing IVF
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maternal Serum Ghrelin Levels in Early IVF Pregnancies: Lack of Prognostic Value for Gestational Outcome and Altered Post-Prandial Responses
In this study, we have assessed the potential prognostic value for gestational outcome of maternal ghrelin levels at very early stages of IVF pregnancies. In addition, ghrelin responses to meal intake were explored at early gestation.
Read the detailed description
Ghrelin is a pleiotropic hormone recently involved in the control of growth and metabolism, whose circulating levels fluctuate in relation to food intake and body mass index. Ghrelin has been detected in the decidualized endometrium, as well as in human and rat placenta, with a distinctive temporal pattern of expression along pregnancy.
Comparison(s): A total of 106 patients undergoing IVF procedures were prospectively recruited. On d-16 and 23 after oocyte retrieval, the patients were subjected to blood sampling after overnight fasting, for determination of serum ghrelin, hCG and progesterone levels. In addition, ghrelin levels were assayed in these groups, 2-h after ingestion of a fixed-calorie meal.
- Conditions
- Pregnancy
- Keywords
- Ghrelin, Pregnancy outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2007 (estimated)
- Study startJun 2004
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Investigators
- Antonio Pellicer, MD, Study chair, Instituto Valenciano de Infertilidad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469807
- Sponsor's protocol ID
- VLC-CV-0604-507-22
- Status last verified
- Apr 2017
- First submitted
- 3 May 2007
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Serum Ghrelin Levels in Early IVF Pregnancies: Lack of Prognostic Value for Gestational Outcome and Altered Post-Prandial Responses
- ClinicalTrials.gov ID
- NCT00469807
- Acronym / sponsor ID
- VLC-CV-0604-507-22
- Conditions
- Pregnancy
- Keywords
- Ghrelin, Pregnancy outcome
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- Jun 2004
- Study completion
- May 2007 (actual)
- First posted
- 7 May 2007 (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.
In this study, we have assessed the potential prognostic value for gestational outcome of maternal ghrelin levels at very early stages of IVF pregnancies. In addition, ghrelin responses to meal intake were explored at early gestation.
Detailed description
Ghrelin is a pleiotropic hormone recently involved in the control of growth and metabolism, whose circulating levels fluctuate in relation to food intake and body mass index. Ghrelin has been detected in the decidualized endometrium, as well as in human and rat placenta, with a distinctive temporal pattern of expression along pregnancy.
Comparison(s): A total of 106 patients undergoing IVF procedures were prospectively recruited. On d-16 and 23 after oocyte retrieval, the patients were subjected to blood sampling after overnight fasting, for determination of serum ghrelin, hCG and progesterone levels. In addition, ghrelin levels were assayed in these groups, 2-h after ingestion of a fixed-calorie meal.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients undergoing IVF
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 28 Apr 2017.
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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.
Antonio Pellicer, MD study chair
Instituto Valenciano de Infertilidad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site 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 1 inclusion and 0 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 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Where can I read the original study information?
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 28 Apr 2017.