EndometriumNCT00436462
Expression of Steroid Receptors in Endometrium
An observational study of Endometrium, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
Expression of steroid receptors in endometrium during ovarian stimulation. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Endometrium
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- Dec 2005to Dec 2007
- 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 20 to 39 years
- Women only
- No healthy volunteers
- Adult
Study population: infertile women
Who may be able to join
- Treatment by IUI,
- BMI:18-29KGR/M2,
- No previous ovarian surgery,
- Normal hysterosalpingography,
- Estradiol < 80pg/ml and progesterone < 1.6ng/ml on day 2 of the cycle
Who cannot join
- Endometriosis,
- Severe male factor
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: Expression of Steroid Receptors in Endometrium During the Early Follicular Phase in Stimulated Cycles
Expression of steroid receptors in endometrium during ovarian stimulation.
Read the detailed description
The purpose of this study is to examine in stimulated cycles a) whether there is a difference in expression of steroid receptors in stroma and glands of endometrium between different days during the follicular phase b)whether there are secretory changes detected by endometrium histology before ovulation c)whether there is an association between expression of steroid receptors in endometrium and exposure to oestradiol and progesterone during the follicular phase.
- Conditions
- Endometrium
- Keywords
- Steroid receptors, Endometrium, IVF, Follicular phase
What is being measured
The primary outcome is the main question the study is designed to answer.
Steroid receptors expression in endometrium during early follicular phase
Measured: 3 months
Secondary outcomes (1)
In which day:day o+2, day 0+4 or day HCG
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startDec 2005
- Primary completionDec 2007
- Study completionDec 2007
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 EndometriumStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Investigators
- Basil C Tarlatzis, MD,PhD, Study director, Unit of Human Reproduction, 1st Department of Obst & Gyn, Aristotle University of Thessaloniki, Papageorgiou Hospital, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436462
- Sponsor's protocol ID
- UHR-4
- Status last verified
- Nov 2009
- First submitted
- 16 Feb 2007
- Last updated
- 9 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Kolibianakis E, Bourgain C, Albano C, Osmanagaoglu K, Smitz J, Van Steirteghem A, Devroey P. Effect of ovarian stimulation with recombinant follicle-stimulating hormone, gonadotropin releasing hormone antagonists, and human chorionic gonadotropin on endometrial maturation on the day of oocyte pick-up. Fertil Steril. 2002 Nov;78(5):1025-9. doi: 10.1016/s0015-0282(02)03323-x.
PubMed 12413988Papanikolaou EG, Bourgain C, Kolibianakis E, Tournaye H, Devroey P. Steroid receptor expression in late follicular phase endometrium in GnRH antagonist IVF cycles is already altered, indicating initiation of early luteal phase transformation in the absence of secretory changes. Hum Reprod. 2005 Jun;20(6):1541-7. doi: 10.1093/humrep/deh793. Epub 2005 Feb 10.
PubMed 15705618
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Steroid Receptors in Endometrium During the Early Follicular Phase in Stimulated Cycles
- ClinicalTrials.gov ID
- NCT00436462
- Acronym / sponsor ID
- UHR-4
- Conditions
- Endometrium
- Keywords
- Steroid receptors, Endometrium, IVF, Follicular phase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 19 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.
Expression of steroid receptors in endometrium during ovarian stimulation.
Detailed description
The purpose of this study is to examine in stimulated cycles a) whether there is a difference in expression of steroid receptors in stroma and glands of endometrium between different days during the follicular phase b)whether there are secretory changes detected by endometrium histology before ovulation c)whether there is an association between expression of steroid receptors in endometrium and exposure to oestradiol and progesterone during the follicular phase.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- infertile women
Key inclusion criteria (5 listed)
- Treatment by IUI,
- BMI:18-29KGR/M2,
- No previous ovarian surgery,
- Normal hysterosalpingography,
- Estradiol < 80pg/ml and progesterone < 1.6ng/ml on day 2 of the cycle
Key exclusion criteria (2 listed)
- Endometriosis,
- Severe male factor
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
Steroid receptors expression in endometrium during early follicular phase
Time frame: 3 months
1 secondary outcome
In which day:day o+2, day 0+4 or day HCG
Time frame: 1 month
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 9 Nov 2009.
- Background: PubMed 12413988Kolibianakis E, Bourgain C, Albano C, Osmanagaoglu K, Smitz J, Van Steirteghem A, Devroey P. Effect of ovarian stimulation with recombinant follicle-stimulating hormone, gonadotropin releasing hormone antagonists, and human chorionic gonadotropin on endometrial maturation on the day of oocyte pick-up. Fertil Steril. 2002 Nov;78(5):1025-9. doi: 10.1016/s0015-0282(02)03323-x.
- Background: PubMed 15705618Papanikolaou EG, Bourgain C, Kolibianakis E, Tournaye H, Devroey P. Steroid receptor expression in late follicular phase endometrium in GnRH antagonist IVF cycles is already altered, indicating initiation of early luteal phase transformation in the absence of secretory changes. Hum Reprod. 2005 Jun;20(6):1541-7. doi: 10.1093/humrep/deh793. Epub 2005 Feb 10.
Related trials for Endometrium
Active, not recruitingPhase 3
Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer
Endometrial Neoplasms
RecruitingPhase 1/2
Pembrolizumab, Lenvatinib and IL-15 Superagonist N-803 in Combination With HER2 Targeting Autologous Dendritic Cell (AdHER2DC) Vaccine in Participants With Advanced or Metastatic Endometrial Cancer
Endometrial Cancer, Cancer of Endometrium
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
RecruitingPhase 2
Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Low-grade Cancer of the Endometrium
Endometrial Cancer, Atypical Hyperplasia
Not yet recruitingObservational study
Endometrial Immune Profile in Recurrent Implantation Failure
Recurrent Implantation Failure, Infertility (IVF Patients)
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 Obst & Gyn, 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 Endometrium, 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 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 9 Nov 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 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?
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?
Steroid receptors expression in endometrium during early follicular phase (time frame: 3 months). 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 NCT00436462, 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 9 Nov 2009.