SubfertilityNCT00438373
LH/HCG Receptor Expression and Retrieval Rates
An observational study of Subfertility, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The purpose of this study is to evaluate if there is an association between the serum LH receptor expression on the day of hCG administration or the day of oocyte retrieval and the retrieval rates at oocyte pick up Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Subfertility
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2007to Jan 2016
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Study population: infertile patients undergoing assisted reproduction tratment
Who may be able to join
- Age <39 years,
- Body mass index (BMI) between 18 and 29 kg/m2,
- Presence of both ovaries,
- FSH levels <10 IU/l.
Who cannot join
- Endometriomas,
- Polycystic ovarian syndrome.
Trial locations and contacts
1 site in 1 country.
Greece1 site
Unit of Human Reproduction, 1st Department of Obstetrics & Gynecology, AUTH, Papageorgiou Hospital
Thessaloniki, 56429
About this study
Official title: Association of LH/HCG Receptor Expression and Retrieval Rates at Oocyte Pick up.
The purpose of this study is to evaluate if there is an association between the serum LH receptor expression on the day of hCG administration or the day of oocyte retrieval and the retrieval rates at oocyte pick up
Read the detailed description
The purpose of this study is to evaluate if there is an association between the serum LH receptor expression on the day of hCG or the day of oocyte retrieval and the retrieval rates at oocyte pick up.
For this purpose, m-RNA copy numbers will be assessed in the blood serum of patients undergoing ovarian stimulation for IVF on different days.
Furthermore, detailed ultrasound scans will be perfomed, as well as assesment of hormonal levels during ovarian stimulation.
- Conditions
- Subfertility
- Keywords
- Subfertility, Luteinizing hormone, receptor
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
LH/hCG receptor expression
Measured: at oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
- Study startJan 2007
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SubfertilityStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- University of Athens
- Responsible party
- Principal investigator, E.M. Kolibianakis, Aristotle University Of Thessaloniki
- Investigators
- Basil C Tarlatzis, MD, PhD, Study director, Unit of Human Reproduction, 1st Department of Obs & Gyne, Aristotle University of Thessaloniki, Papageorgiou Hospital, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438373
- Sponsor's protocol ID
- UHR-1
- Status last verified
- Feb 2015
- First submitted
- 21 Feb 2007
- Last updated
- 26 Feb 2015
- Results posted
- No
Publications
Patsoula E, Loutradis D, Drakakis P, Michalas L, Bletsa R, Michalas S. Messenger RNA expression for the follicle-stimulating hormone receptor and luteinizing hormone receptor in human oocytes and preimplantation-stage embryos. Fertil Steril. 2003 May;79(5):1187-93. doi: 10.1016/s0015-0282(03)00071-2.
PubMed 12738515Patsoula E, Loutradis D, Drakakis P, Kallianidis K, Bletsa R, Michalas S. Expression of mRNA for the LH and FSH receptors in mouse oocytes and preimplantation embryos. Reproduction. 2001 Mar;121(3):455-61. doi: 10.1530/rep.0.1210455.
PubMed 11226072
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of LH/HCG Receptor Expression and Retrieval Rates at Oocyte Pick up.
- ClinicalTrials.gov ID
- NCT00438373
- Acronym / sponsor ID
- UHR-1
- Conditions
- Subfertility
- Keywords
- Subfertility, Luteinizing hormone, receptor
- Study type
- Observational
- Recruitment status
- Suspended
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- University of Athens
- Study start
- Jan 2007
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 22 Feb 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.
The purpose of this study is to evaluate if there is an association between the serum LH receptor expression on the day of hCG administration or the day of oocyte retrieval and the retrieval rates at oocyte pick up
Detailed description
The purpose of this study is to evaluate if there is an association between the serum LH receptor expression on the day of hCG or the day of oocyte retrieval and the retrieval rates at oocyte pick up.
For this purpose, m-RNA copy numbers will be assessed in the blood serum of patients undergoing ovarian stimulation for IVF on different days.
Furthermore, detailed ultrasound scans will be perfomed, as well as assesment of hormonal levels during ovarian stimulation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- infertile patients undergoing assisted reproduction tratment
Key inclusion criteria (4 listed)
- Age <39 years,
- Body mass index (BMI) between 18 and 29 kg/m2,
- Presence of both ovaries,
- FSH levels <10 IU/l.
Key exclusion criteria (2 listed)
- Endometriomas,
- Polycystic ovarian syndrome.
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
LH/hCG receptor expression
Time frame: at oocyte retrieval
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2015.
- Background: PubMed 12738515Patsoula E, Loutradis D, Drakakis P, Michalas L, Bletsa R, Michalas S. Messenger RNA expression for the follicle-stimulating hormone receptor and luteinizing hormone receptor in human oocytes and preimplantation-stage embryos. Fertil Steril. 2003 May;79(5):1187-93. doi: 10.1016/s0015-0282(03)00071-2.
- Background: PubMed 11226072Patsoula E, Loutradis D, Drakakis P, Kallianidis K, Bletsa R, Michalas S. Expression of mRNA for the LH and FSH receptors in mouse oocytes and preimplantation embryos. Reproduction. 2001 Mar;121(3):455-61. doi: 10.1530/rep.0.1210455.
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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.
Basil C Tarlatzis, MD, PhD study director
Unit of Human Reproduction, 1st Department of Obs & Gyne, Aristotle University of Thessaloniki, Papageorgiou Hospital, Greece
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 Subfertility, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 4 inclusion and 2 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: paused, as of the sponsor's last update on 26 Feb 2015. 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 Greece. 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?
Results are not available in the source record.
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?
LH/hCG receptor expression (time frame: at oocyte retrieval). 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 NCT00438373, which also lists 2 linked publications.
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 26 Feb 2015.