Androgen Receptor Gene OverexpressionNCT03433768
Androgen Receptor mRNA Expression is Positively Associated With Live Birth in Women Undergoing IVF Independently of the Type of Ovarian Response
An observational study of Androgen Receptor Gene Overexpression and Normal Responders, run by Aristotle University Of Thessaloniki.
Trial summary
AR is a steroid hormone receptor that regulates various genes' expression and affects cellular proliferation and differentiation. Androgens interact with AR, exert their paracrine action on granulosa cells and regulate gonadotropin synthesis, follicle development, oocyte maturation and corpus luteum function. Read more about this study
- Who is it for?
- Ages 20 to 42 years, women only
- Conditions the study is for
- Androgen Receptor Gene Overexpression, Normal Responders, Poor Ovarian Response
- What is being tested?
- Real time PCR
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 14 Sep 2014to 10 Jan 2018
- How long will I take part?
- 4 Weeks
- 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 42 years
- Women only
- Adult
Study population: Forty normal responders and twenty-seven poor responders according to Bologna criteria, undergoing IVF/ICSI. Ovarian stimulation was performed with 200 IU recombinant follicle stimulating hormone (rFSH) and gonadotrophin releasing hormone (GnRH) antagonists. Triggering of final oocyte maturation was performed by recombinant human chorionic gonadotrophic (rhCG)
Who may be able to join
- Women with poor ovarian response according to bologna criteria
- Advanced maternal age (≥40 years) or any other risk factor for poor ovarian response
- A previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol)
- Abnormal ovarian reserve test, (AFC ˂5-7 follicles or AMH ˂0.5-1.1 ng/ml).
- Women with normal ovarian response with normal menstrual cycles, normal astral follicle count and normal hormonal assay.
Who cannot join
- Not more than 43 years old.
- No history of malignancies, endometriosis or polycystic ovary syndrome.
- Underlying genetic cause of infertility
- History of severe cardiac, hepatic or renal disease.
- History of systemic disease or treatment during the last three (3) months
- Participation in another interventional study and a likelihood of being unavailable for follow-up.
About this study
Official title: Androgen Receptor (AR) mRNA Expression is Positively Associated With Live Birth in Women Undergoing In-vitro Fertilization Independently of the Type of Ovarian Response
AR is a steroid hormone receptor that regulates various genes' expression and affects cellular proliferation and differentiation. Androgens interact with AR, exert their paracrine action on granulosa cells and regulate gonadotropin synthesis, follicle development, oocyte maturation and corpus luteum function. Estrogens increase AR mRNA and testosterone binding site in uterine endometrium and leiomyoma. In human cancer cells, low estradiol increases AR levels, suggesting the estrogen/androgen ratio as a predictor of sex steroid response. AR mRNA expression is, also, regulated by progesterone. Although AR mRNA is expressed in the female reproductive tissues, its expression has never been studied in peripheral blood.
- Conditions
- Androgen Receptor Gene Overexpression, Normal Responders, Poor Ovarian Response, Bologna Criteria
- Being tested
- Real time PCR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real time PCRGenetic
We take peripheral blood sample at day one, six and ten of ovarian stimulation and measure mRNA expression of androgen receptor.
| Study group | Role | What they receive |
|---|---|---|
| poor responders | Not described Receives: Genetic: Real time PCR | |
| normal responders | Not described Receives: Genetic: Real time PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Androgen Receptor mRNA expression
The expression of androgen receptor mRNA in peripheral blood of normal and poor responders level of expression in peripheral blood according to the Delta-Delta-Ct (ddCt) Algorithm.
Percentage of increase?
Measured: day one, six and ten of ovarian stimulation
Secondary outcomes (3)
Serum LH levels in peripheral blood of normal and poor responders
level of hormone in international unit.
Measured: day one, six and ten of ovarian stimulation
Serum progesterone levels in peripheral blood of normal and poor responders.
level of hormone in international unit.
Measured: day one, six and ten of ovarian stimulation
Serum estradiol levels in peripheral blood of normal and poor responders
level of hormone in international unit.
Measured: day one, six and ten of ovarian stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start14 Sep 2014
- Primary completion10 Oct 2017
- Study completion10 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgen Receptor Gene OverexpressionStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, E.M. Kolibianakis, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433768
- Sponsor's protocol ID
- UHR 13
- Status last verified
- Feb 2018
- First submitted
- 31 Jan 2018
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Androgen Receptor (AR) mRNA Expression is Positively Associated With Live Birth in Women Undergoing In-vitro Fertilization Independently of the Type of Ovarian Response
- ClinicalTrials.gov ID
- NCT03433768
- Acronym / sponsor ID
- UHR 13
- Conditions
- Androgen Receptor Gene Overexpression, Normal Responders, Poor Ovarian Response, Bologna Criteria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 14 Sep 2014 (actual)
- Primary completion
- 10 Oct 2017 (actual)
- Study completion
- 10 Jan 2018 (actual)
- First posted
- 15 Feb 2018 (actual)
- 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.
AR is a steroid hormone receptor that regulates various genes' expression and affects cellular proliferation and differentiation. Androgens interact with AR, exert their paracrine action on granulosa cells and regulate gonadotropin synthesis, follicle development, oocyte maturation and corpus luteum function. Estrogens increase AR mRNA and testosterone binding site in uterine endometrium and leiomyoma. In human cancer cells, low estradiol increases AR levels, suggesting the estrogen/androgen ratio as a predictor of sex steroid response. AR mRNA expression is, also, regulated by progesterone. Although AR mRNA is expressed in the female reproductive tissues, its expression has never been studied in peripheral blood.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| poor responders | – | Genetic: Real time PCR |
| normal responders | – | Genetic: Real time PCR |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Forty normal responders and twenty-seven poor responders according to Bologna criteria, undergoing IVF/ICSI. Ovarian stimulation was performed with 200 IU recombinant follicle stimulating hormone (rFSH) and gonadotrophin releasing hormone (GnRH) antagonists. Triggering of final oocyte maturation was performed by recombinant human chorionic gonadotrophic (rhCG)
Key inclusion criteria (5 listed)
- Women with poor ovarian response according to bologna criteria
- Women with normal ovarian response with normal menstrual cycles, normal astral follicle count and normal hormonal assay.
Key exclusion criteria (6 listed)
- Not more than 43 years old.
- No history of malignancies, endometriosis or polycystic ovary syndrome.
- Underlying genetic cause of infertility
- History of severe cardiac, hepatic or renal disease.
- History of systemic disease or treatment during the last three (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 |
|---|---|---|
| Real time PCRWe take peripheral blood sample at day one, six and ten of ovarian stimulation and measure mRNA expression of androgen receptor. | Genetic | normal responders, poor responders |
Primary outcome
Androgen Receptor mRNA expression
Time frame: day one, six and ten of ovarian stimulation
The expression of androgen receptor mRNA in peripheral blood of normal and poor responders level of expression in peripheral blood according to the Delta-Delta-Ct (ddCt) Algorithm. Percentage of increase?
3 secondary outcomes
Serum LH levels in peripheral blood of normal and poor responders
Time frame: day one, six and ten of ovarian stimulation
Serum progesterone levels in peripheral blood of normal and poor responders.
Time frame: day one, six and ten of ovarian stimulation
Serum estradiol levels in peripheral blood of normal and poor responders
Time frame: day one, six and ten of ovarian stimulation
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 2018.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Androgen Receptor Gene Overexpression and Normal Responders, run by Aristotle University Of Thessaloniki.
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 6 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 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Androgen Receptor mRNA expression (time frame: day one, six and ten of ovarian stimulation). 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 2018.