InfertilityNCT02205866
Incidence of Non Receptive Endometrium in Obese Women
A study testing Endometrial Receptivity Array analysis of endometrial biopsy in people with Infertility, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 3 sites in 2 countries.
Trial summary
This study evaluates the incidence of Non Receptive endometrium in obese infertile women compared to infertile normal weight women using Endometrial Receptivity Array (ERA) test, containing 238 genes, identifying the receptivity status of an endometrial sample and diagnosing the patient's Window of Implantation… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Endometrial Receptivity Array analysis of endometrial biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Aug 2014to 31 Jul 2017
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertile women: > 1 year of regular unprotected intercourse without evidence of pregnancy.
- Normal uterus by 2D/3D ultrasound scan and/or hysteroscopy
- No endometriosis
- Presence of both ovaries
- < 45 years old (in ovum donation, outcome parameters are not affected until this age in all the current published studies).
Who cannot join
- Hydrosalpinx
- Stage 3-4 endometriosis diagnosed with ultrasound, laparoscopy/ laparotomy.
- Implantation failure (≥ 4 pre-embryos of good quality transferred without pregnancy)
- Recurrent pregnancy loss (≥ 2 pregnancies biochemical / clinical)
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Baylor College of Medicine
Houston, Texas, 77030
Stamford University
Palo Alto, California, 94305-5101
About this study
Official title: Incidence of Not Receptive Endometrium During the Window of Implantation as Body Mass Index by Testing ERA.
This study evaluates the incidence of Non Receptive endometrium in obese infertile women compared to infertile normal weight women using Endometrial Receptivity Array (ERA) test, containing 238 genes, identifying the receptivity status of an endometrial sample and diagnosing the patient's Window of Implantation, regardless of the histological appearance of the sample. An endometrial biopsy is collected from the uterine fundus, either in a natural cycle or in a hormonal replacement therapy (HRT) cycle and the test is performed.
- Conditions
- Infertility
- Being tested
- Endometrial Receptivity Array analysis of endometrial biopsy
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial Receptivity Array analysis of endometrial biopsyOther
A biopsy of endometrium is peformed and Endometrial Receptivity Array analysis is carried out, as well as analysis of fat distribution and risk factors of Metabolic Syndrome.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Non Obese patients Receives: Other: Endometrial Receptivity Array analysis of endometrial biopsy |
| Group B | Experimental | Obese patients Receives: Other: Endometrial Receptivity Array analysis of endometrial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non Receptive Endometrium
To evaluate the incidence of Not Receptive endometrium in obese infertile women compared to infertile normal weight women using an adequate sample size.
Measured: 25 days
Secondary outcomes (3)
Distribution of fat and risk factors
Carry out a subanalysis concerning the distribution of central and peripheric fat and risk factors of metabolic syndrome including: Age (years); Height (m); Weight (kg) ; BMI (kg/m2); Waist (cm) ; Hip (cm); Index waist-hip ratio (WHR) waist (cm) / hip (cm); Blood pressure; insulinemia Fasting blood glucose (mmol / L); PTG ( tolerance oral glucose ) (mmol / L), Total cholesterol and fractions; Triglycerides Microalbuminuria; bA1C, HC-reactive protein.
Measured: 4 months
Look for specific endometrial gene patterns.
Find patterns of expression of specific genes in endometrial obese women: we will by analyzing the expression of 238 genes obtained after endometrial endometrial biopsy.
Measured: 25 days
Evaluate the result of assisted reproduction treatment.
Relate if the displacement of the WOI induced by the obesity is clinically relevant after the personalized embryo transfer.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionJul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Bellver, Instituto Valenciano de Infertilidad, IVI VALENCIA
- Investigators
- Jose Bellver, MD PhD, Principal investigator, IVI Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205866
- Sponsor's protocol ID
- 1403-VLC-012-JB
- Status last verified
- Jun 2019
- First submitted
- 25 Jul 2014
- Last updated
- 28 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Comstock IA, Diaz-Gimeno P, Cabanillas S, Bellver J, Sebastian-Leon P, Shah M, Schutt A, Valdes CT, Ruiz-Alonso M, Valbuena D, Simon C, Lathi RB. Does an increased body mass index affect endometrial gene expression patterns in infertile patients? A functional genomics analysis. Fertil Steril. 2017 Mar;107(3):740-748.e2. doi: 10.1016/j.fertnstert.2016.11.009. Epub 2016 Dec 2.
PubMed 27919438
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Not Receptive Endometrium During the Window of Implantation as Body Mass Index by Testing ERA.
- ClinicalTrials.gov ID
- NCT02205866
- Acronym / sponsor ID
- 1403-VLC-012-JB
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 31 Jul 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.
This study evaluates the incidence of Non Receptive endometrium in obese infertile women compared to infertile normal weight women using Endometrial Receptivity Array (ERA) test, containing 238 genes, identifying the receptivity status of an endometrial sample and diagnosing the patient's Window of Implantation, regardless of the histological appearance of the sample. An endometrial biopsy is collected from the uterine fundus, either in a natural cycle or in a hormonal replacement therapy (HRT) cycle and the test is performed.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Endometrial Receptivity Array analysis of endometrial biopsyNon Obese patients |
| Group B | Experimental | Other: Endometrial Receptivity Array analysis of endometrial biopsyObese patients |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Infertile women: > 1 year of regular unprotected intercourse without evidence of pregnancy.
- Normal uterus by 2D/3D ultrasound scan and/or hysteroscopy
- No endometriosis
- Presence of both ovaries
- < 45 years old (in ovum donation, outcome parameters are not affected until this age in all the current published studies).
Key exclusion criteria (4 listed)
- Hydrosalpinx
- Stage 3-4 endometriosis diagnosed with ultrasound, laparoscopy/ laparotomy.
- Implantation failure (≥ 4 pre-embryos of good quality transferred without pregnancy)
- Recurrent pregnancy loss (≥ 2 pregnancies biochemical / clinical)
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 Receptivity Array analysis of endometrial biopsyA biopsy of endometrium is peformed and Endometrial Receptivity Array analysis is carried out, as well as analysis of fat distribution and risk factors of Metabolic Syndrome. | Other | Group A, Group B |
Primary outcome
Non Receptive Endometrium
Time frame: 25 days
To evaluate the incidence of Not Receptive endometrium in obese infertile women compared to infertile normal weight women using an adequate sample size.
3 secondary outcomes
Distribution of fat and risk factors
Time frame: 4 months
Look for specific endometrial gene patterns.
Time frame: 25 days
Evaluate the result of assisted reproduction treatment.
Time frame: 12 months
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 Jun 2019.
- Derived from this study: PubMed 27919438Comstock IA, Diaz-Gimeno P, Cabanillas S, Bellver J, Sebastian-Leon P, Shah M, Schutt A, Valdes CT, Ruiz-Alonso M, Valbuena D, Simon C, Lathi RB. Does an increased body mass index affect endometrial gene expression patterns in infertile patients? A functional genomics analysis. Fertil Steril. 2017 Mar;107(3):740-748.e2. doi: 10.1016/j.fertnstert.2016.11.009. Epub 2016 Dec 2.
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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.
Jose Bellver, MD PhD principal investigator
IVI Valencia
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endometrial Receptivity Array analysis of endometrial biopsy in people with Infertility, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 3 sites in 2 countries.
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 4 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 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, 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?
Non Receptive Endometrium (time frame: 25 days). 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 NCT02205866, which also lists 1 linked publication.
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 Jun 2019.