Genomic Human Endometrial Expression ProfileNCT01778452
Endometrial Genomic Profile in Endometrial Priming
A study testing endometrial biopsy in people with Genomic Human Endometrial Expression Profile, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
The aim of this study is to analyse genomics profile expression in endometrium under different endometrial priming for recipients. 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
- Genomic Human Endometrial Expression Profile
- What is being tested?
- endometrial biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2009to Jan 2013
- 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
- 6 egg healthy volunteer egg donors.
- Volunteers.
- 18-35 years old
- Healthy.
- BMI <28.
Who cannot join
- - BMI > 28
- Smokers-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Profile Study of Genomics Endometrial Expression After Gonadotropin-releasing Hormone Agonist Administration and GnRH in Endometrial Priming.
The aim of this study is to analyse genomics profile expression in endometrium under different endometrial priming for recipients.
Read the detailed description
We analyze the genomic profile of egg donors in different endometrial priming protocols, compared with natural cycle, including the conventional single long acting GnRH agonist injection in the mid luteal phase of the previous cycle of the endometrial priming and the single daily antagonist injection (Cetrorelix 0.25 mg) administered in the early follicular phase followed by endometrial priming. Endometrial biopsy will be taken in luteinizing hormone
- 7 or with P4 +5 in cases with endometrial priming with oestrogens therapy.
- Being tested
- endometrial biopsy
- Keywords
- Endometrial priming, genomic expression. Natural cycle. Antagonist GnRH.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endometrial biopsyProcedure or surgery
endometrial biopsy
| Study group | Role | What they receive |
|---|---|---|
| Natural cycle | Active comparator | Natural cycle endometrial biopsy, lh+7 Receives: Procedure: endometrial biopsy |
| Antagonist cycle + endometrial priming. | Experimental | Antagonist cycle + endometrial priming for egg donation program. endometrial biopsy, p4+5 Receives: Procedure: endometrial biopsy |
| Agonist cycle + endometrial priming. | Experimental | Agonist cycle + endometrial priming for egg donation program endometrial biopsy, p4+5 Receives: Procedure: endometrial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
genetic endometrial human profile expression
implantation related genes profile expression
Measured: Oocyte donors will be followed up for four to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startNov 2009
- Primary completionOct 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genomic Human Endometrial Expression ProfileStudies 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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Collaborators
- Igenomix
- Responsible party
- Sponsor
- Investigators
- Carmen Vidal, MDphD, Principal investigator, IVI Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778452
- Sponsor's protocol ID
- VLC18012013
- Status last verified
- Feb 2013
- First submitted
- 25 Jan 2013
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profile Study of Genomics Endometrial Expression After Gonadotropin-releasing Hormone Agonist Administration and GnRH in Endometrial Priming.
- ClinicalTrials.gov ID
- NCT01778452
- Acronym / sponsor ID
- VLC18012013
- Keywords
- Endometrial priming, genomic expression. Natural cycle. Antagonist GnRH.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Collaborators
- Igenomix
- Study start
- Nov 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 29 Jan 2013 (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 aim of this study is to analyse genomics profile expression in endometrium under different endometrial priming for recipients.
Detailed description
We analyze the genomic profile of egg donors in different endometrial priming protocols, compared with natural cycle, including the conventional single long acting GnRH agonist injection in the mid luteal phase of the previous cycle of the endometrial priming and the single daily antagonist injection (Cetrorelix 0.25 mg) administered in the early follicular phase followed by endometrial priming. Endometrial biopsy will be taken in luteinizing hormone
- 7 or with P4 +5 in cases with endometrial priming with oestrogens therapy.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Natural cycle | Active comparator | Procedure: endometrial biopsyNatural cycle endometrial biopsy, lh+7 |
| Antagonist cycle + endometrial priming. | Experimental | Procedure: endometrial biopsyAntagonist cycle + endometrial priming for egg donation program. endometrial biopsy, p4+5 |
| Agonist cycle + endometrial priming. | Experimental | Procedure: endometrial biopsyAgonist cycle + endometrial priming for egg donation program endometrial biopsy, p4+5 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 6 egg healthy volunteer egg donors.
- Volunteers.
- 18-35 years old
- Healthy.
- BMI <28.
Key exclusion criteria (2 listed)
- - BMI > 28
- Smokers-
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 biopsyendometrial biopsy | Procedure or surgery | Agonist cycle + endometrial priming., Antagonist cycle + endometrial priming., Natural cycle |
Primary outcome
genetic endometrial human profile expression
Time frame: Oocyte donors will be followed up for four to six months
implantation related genes profile expression
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 15 Feb 2013.
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.
Carmen Vidal, MDphD principal investigator
IVI Valencia
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 Genomic Human Endometrial Expression Profile, 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 15 Feb 2013. 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.
What does the primary outcome measure?
genetic endometrial human profile expression (time frame: Oocyte donors will be followed up for four to six months). It is what the study was designed to measure, not a finding.
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 15 Feb 2013.