EndometrialERANCT02280798
Endometrial Gene Expression in Different Protocols of Endometrial Preparation for Embryo Transfer'
An observational study of Endometrial, run by IVI Madrid at 1 site in Spain.
Trial summary
Do differences in endometrial gene expression exist after different protocols of endometrial preparation for embryo transfer? The recent apparition of endometrial receptive arrays technology let us know if endometrial is receptive or not in patients with some problems of infertility as implantation failure, for that… Read more about this study
- Who is it for?
- Ages 18 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial
- What is being tested?
- Endometrial Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2014to Apr 2015
- 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 34 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: A total of 5 volunteers from our egg donation program were included in the study from Setember 2014 to jnuary 2015
Who may be able to join
- age between 18 and 35 years
- regular menstrual cycles (between 25 and 35 days)
- normal basal hormones(follicle-stimulating hormone [FSH] and LH <10 IU/ mL and estradiol <60 pg/mL)
- normal karyotype
- body massindex between 18 and 25 kg/m2
- negative serology
- normal cervical cytology in the past year, and a vaginal ultrasound without evidence of any pathologic conditions
Who cannot join
- endometriosis
- polycystic ovariansyndrome
- use of an intrauterine device in the last 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endometrial Gene Expression in Different Protocols of Endometrial Preparation
Do differences in endometrial gene expression exist after different protocols of endometrial preparation for embryo transfer? The recent apparition of endometrial receptive arrays technology let us know if endometrial is receptive or not in patients with some problems of infertility as implantation failure, for that we want to know if this technology would tell us if the different kind of protocols for endometrial preparation origin differences that could explain some of the founded results.
Read the detailed description
Do differences in endometrial gene expression exist after different protocols of endometrial preparation for embryo transfer? The clinical results in different publications showed different results, some of them described the natural cycle superior as the substituted cycles, and in contrast other large series showed superior results in substituted cycles than natural but with an increased of pregnancies losses. The recent apparition of endometrial receptive arrays technology let us know if endometrial is receptive or not in patients with some problems of infertility as implantation failure, for that we want to know if this technology would tell us if the different kind of protocols for endometrial preparation origin differences that could explain some of the founded results.
- Conditions
- Endometrial
- Being tested
- Endometrial Biopsy
- Keywords
- ERA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial BiopsyProcedure or surgery
4 endometrial biopsy
| Study group | Role | What they receive |
|---|---|---|
| pilot study | A total of 5 volunteers from our egg donation program were included in the study with 4 endometrial biopsies for each one after 4 diferente protocols
* Endometrial biopsy after Stimulated cycle
* Endometrial biopsy after Natural Cycle
* Endometrial biopsy after Natural modified cycle: the biopsy is taken seven days after the hCG
* Endometrial biopsy after Hormone Replacement Therapy Cycle Receives: Procedure: Endometrial Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial receptivity
Total RNA was extracted using the TRIzol method according to the manufacturer's recommendations (Life Technologies). Approximately 1-2 mg of total RNA was obtained per milligram of endometrial tissue. The RNA quality was assessed by loading 300 ng of total RNA onto an RNA LabChip and was analyzed in an A2100 Bioanalyzer (Agilent Technologies). Only samples with a RNA integrity number >7 were selected for microarray analysis.
Sample preparation and hybridization was adapted from the Agilent technical manual. Hybridized microarrays were scanned in an Axon 4100A scanner (Molecular Devices), and the data were extracted with the GenePix Pro 6.0 software (Molecular Devices). The ERA microarray validation has been previously published. Reverse transcriptase-polymerase chain reaction (PCR) was performed for four selected up-regulated genes: GPX3, FXYD2, SPP1, and MT1G.
The ERA gene expression values were preprocessed, normalized, and statistically analyzed. Briefly, the half background
Measured: 4 months
Secondary outcomes (1)
Hormonal profile
Hormonal profile different dates of protocols
Measured: LH,E2,P4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometrialStudies 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
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Igenomix
- Responsible party
- Principal investigator, mcerrillo, IVI Madrid
- Investigators
- Cerrillo M Maria, doctor, Principal investigator, IVI Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280798
- Sponsor's protocol ID
- 1407-MAD-056-MC
- Acronym
- ERA
- Status last verified
- Feb 2016
- First submitted
- 16 Sep 2014
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Gene Expression in Different Protocols of Endometrial Preparation
- ClinicalTrials.gov ID
- NCT02280798
- Acronym / sponsor ID
- ERA / 1407-MAD-056-MC
- Conditions
- Endometrial
- Keywords
- ERA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- IVI MadridUniversity, hospital or other
- Collaborators
- Igenomix
- Study start
- Dec 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 3 Nov 2014 (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.
Do differences in endometrial gene expression exist after different protocols of endometrial preparation for embryo transfer? The recent apparition of endometrial receptive arrays technology let us know if endometrial is receptive or not in patients with some problems of infertility as implantation failure, for that we want to know if this technology would tell us if the different kind of protocols for endometrial preparation origin differences that could explain some of the founded results.
Detailed description
Do differences in endometrial gene expression exist after different protocols of endometrial preparation for embryo transfer? The clinical results in different publications showed different results, some of them described the natural cycle superior as the substituted cycles, and in contrast other large series showed superior results in substituted cycles than natural but with an increased of pregnancies losses. The recent apparition of endometrial receptive arrays technology let us know if endometrial is receptive or not in patients with some problems of infertility as implantation failure, for that we want to know if this technology would tell us if the different kind of protocols for endometrial preparation origin differences that could explain some of the founded results.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pilot study | – | Procedure: Endometrial BiopsyA total of 5 volunteers from our egg donation program were included in the study with 4 endometrial biopsies for each one after 4 diferente protocols * Endometrial biopsy after Stimulated cycle * Endometrial biopsy after Natural Cycle * Endometrial biopsy after Natural modified cycle: the biopsy is taken seven days after the hCG * Endometrial biopsy after Hormone Replacement Therapy Cycle |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A total of 5 volunteers from our egg donation program were included in the study from Setember 2014 to jnuary 2015
Key inclusion criteria (7 listed)
- age between 18 and 35 years
- regular menstrual cycles (between 25 and 35 days)
- normal basal hormones(follicle-stimulating hormone [FSH] and LH <10 IU/ mL and estradiol <60 pg/mL)
- normal karyotype
- body massindex between 18 and 25 kg/m2
Key exclusion criteria (3 listed)
- endometriosis
- polycystic ovariansyndrome
- use of an intrauterine device in the last 3 months.
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 Biopsy4 endometrial biopsy | Procedure or surgery | pilot study |
Primary outcome
Endometrial receptivity
Time frame: 4 months
Total RNA was extracted using the TRIzol method according to the manufacturer's recommendations (Life Technologies). Approximately 1-2 mg of total RNA was obtained per milligram of endometrial tissue. The RNA quality was assessed by loading 300 ng of total RNA onto an RNA LabChip and was analyzed in an A2100 Bioanalyzer (Agilent Technologies). Only samples with a RNA integrity number >7 were selected for microarray analysis. Sample preparation and hybridization was adapted from the Agilent technical manual. Hybridized microarrays were scanned in an Axon 4100A scanner (Molecular Devices), and the data were extracted with the GenePix Pro 6.0 software (Molecular Devices). The ERA microarray validation has been previously published. Reverse transcriptase-polymerase chain reaction (PCR) was performed for four selected up-regulated genes: GPX3, FXYD2, SPP1, and MT1G. The ERA gene expression values were preprocessed, normalized, and statistically analyzed. Briefly, the half background
1 secondary outcome
Hormonal profile
Time frame: LH,E2,P4
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 23 Feb 2016.
- Individual participant dataSharing planned: Yes
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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.
Cerrillo M Maria, doctor principal investigator
IVI Madrid
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 Endometrial, run by IVI Madrid 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 7 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 23 Feb 2016. 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?
Endometrial receptivity (time frame: 4 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 23 Feb 2016.