Premature LuteinizationNCT00447850
Endometrial Gene Expression Profile in Controlled Ovarian Stimulation Cycles With Premature Luteinization
A study testing endometrial biopsy in people with Premature Luteinization, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
Previous studies have suggested that premature luteinization (PL)during controlled ovarian stimulation (COS) decreases the implantation rate due to a negative effect on the endometrium receptivity. This study aims to describe the impact on endometrial gene expression of PL in GnRH antagonist and GnRH agonist cycles. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Luteinization
- What is being tested?
- endometrial biopsy
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteSpain
- Study dates
- Apr 2007to Jul 2009
- Phase
- Interventional
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Oocyte donors
- Age between 18-35 years old
- BMI 18-29
- NORMOGONADOTROPHICS
- PROGESTERONE ≥ 1.2 ng/ml on hCG day
Who cannot join
- PolyCystic Ovarian Syndrome (PCOS)
- Endometriosis
Trial locations and contacts
1 site in 1 country.
About this study
Previous studies have suggested that premature luteinization (PL)during controlled ovarian stimulation (COS) decreases the implantation rate due to a negative effect on the endometrium receptivity. This study aims to describe the impact on endometrial gene expression of PL in GnRH antagonist and GnRH agonist cycles.
- Conditions
- Premature Luteinization
- Being tested
- endometrial biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endometrial biopsyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2007 (estimated)
- Study startApr 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature LuteinizationStudies 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
- Interventional
- Phase
- Phase N/A
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Investigators
- Elena Labarta, MD, Principal investigator, Instituto Valenciano de la Infertilidad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447850
- Sponsor's protocol ID
- VLC-EL-1006- 307-2
- Status last verified
- Sep 2009
- First submitted
- 13 Mar 2007
- Last updated
- 21 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Gene Expression Profile in Controlled Ovarian Stimulation Cycles With Premature Luteinization
- ClinicalTrials.gov ID
- NCT00447850
- Acronym / sponsor ID
- VLC-EL-1006- 307-2
- Conditions
- Premature Luteinization
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 15 Mar 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.
Previous studies have suggested that premature luteinization (PL)during controlled ovarian stimulation (COS) decreases the implantation rate due to a negative effect on the endometrium receptivity. This study aims to describe the impact on endometrial gene expression of PL in GnRH antagonist and GnRH agonist cycles.
Study design
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Oocyte donors
- Age between 18-35 years old
- BMI 18-29
- NORMOGONADOTROPHICS
- PROGESTERONE ≥ 1.2 ng/ml on hCG day
Key exclusion criteria (2 listed)
- PolyCystic Ovarian Syndrome (PCOS)
- Endometriosis
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 |
|---|---|---|
| endometrial biopsy | Procedure or surgery | – |
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 21 Sep 2009.
Related trials for Premature Luteinization
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Infertility, Female, Reproductive Sterility
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.
Elena Labarta, MD principal investigator
Instituto Valenciano de la Infertilidad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endometrial biopsy in people with Premature Luteinization, 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 5 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: finished, as of the sponsor's last update on 21 Sep 2009. 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 21 Sep 2009.