antimüllerian Hormone and Gonadotrophin Receptor Polymorphism as Predictors of Ovarian ResponseGREPAMORNCT03388099
Impact of Gonadotrophin REceptor Polimorphisms on the Relationship Between Serum AMH and Ovarian Response
An observational study of antimüllerian Hormone and Gonadotrophin Receptor Polymorphism as Predictors of Ovarian Response, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
Aim of study: To compare the relationship between serum AMH and ovarian response for IVF with the GnRH antagonist protocol in patients who are carriers of FSH and/or LH receptor polymorphisms with those that are not. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- antimüllerian Hormone and Gonadotrophin Receptor Polymorphism as Predictors of Ovarian Response
- How many people
- 296 participants
- Where
- 1 siteSpain
- Study dates
- 11 Jan 2018to 18 Dec 2019
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Infertile Patients undergoing IVF treatments
Who may be able to join
- 18-45 years of age presenting to IVF clinic
- BMI of 18-35 kg/m2
- Having been tested for serum AMH with the Elecsys assay
- Being planned to undergo ovarian stimulation cycle for IVF with the GnRH antagonist protocol
- Signed written informed consent or waiver
Who cannot join
- Current or past disease affecting ovaries, gonadotropin or sex steroid
- Current hormone therapy
Trial locations and contacts
1 site in 1 country.
Spain1 site
Valencian Institute of Infertility, IVI RMA. Valencia
Valencia, 46015
About this study
Aim of study: To compare the relationship between serum AMH and ovarian response for IVF with the GnRH antagonist protocol in patients who are carriers of FSH and/or LH receptor polymorphisms with those that are not.
Read the detailed description
Serum AMH has shown to have a high predictive capability of the ovarian response to stimulation for IVF. On the other hand, patients who are carriers of polymorphisms in the FSH and LH receptors, have shown to need higher doses of gonadotrophins for ovarian stimulation. The proportion of carriers has been described to be around 20% of the population. Nevertheless, the determination of these polymorphisms is not performed in routine practice. It is unknown if their presence affects to the relationship between serum AMH levels and ovarian response.
This is a prospective, single center, non-interventional, cohorts study.
- Conditions
- antimüllerian Hormone and Gonadotrophin Receptor Polymorphism as Predictors of Ovarian Response
- Keywords
- gonadotrophin receptor polymorphism, antimüllerian hormone, ovarian response, ovarian stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with FSH/LH polymorphisms | Infertile patients will undergo an ovarian stimulation with FSH and/or hMG. Doses will be chosen according to BMI, Antral follicle count, AMH and age. | |
| patients without FSH/LH polymorphisms | Infertile patients will undergo an ovarian stimulation with FSH and/or hMG. Doses will be chosen according to BMI, Antral follicle count, AMH and age. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gonadotrophin receptor polymorphisms and ovarian response and AMH value
To compare the relationship between serum AMH and ovarian response for IVF with the GnRH antagonist protocol in patients who are carriers of FSH and/or LH receptor polymorphisms with those that are not.
Measured: 1 year
Secondary outcomes (3)
polymorphisms in the FSH receptor (FSHR) variant N680S
To define the incidence of carriers of polymorphisms in the FSH receptor (FSHR) variant N680S (homozygous and heterozygous) among women undergoing ovarian stimulation for IVF.
Measured: 1 year
polymorphisms in the LH receptor (LHR) variant N312S
To define the incidence of carriers of polymorphisms in the LH receptor (LHR) variant N312S (homozygous and heterozygous) among women undergoing ovarian stimulation for IVF.
Measured: 1 year
Doses of gonadotrophin needed and polymorphisms
To analyse the doses of gonadotrophins needed for stimulation on each group of patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start11 Jan 2018
- Primary completion18 Dec 2019
- Study completion18 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for antimüllerian Hormone and Gonadotrophin Receptor Polymorphism as Predictors of Ovarian ResponseStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388099
- Sponsor's protocol ID
- 1706-VLC-058-EB
- Acronym
- GREPAMOR
- Status last verified
- Dec 2019
- First submitted
- 22 Dec 2017
- Last updated
- 20 Dec 2019
- 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 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Gonadotrophin REceptor Polimorphisms on the Relationship Between Serum AMH and Ovarian Response
- ClinicalTrials.gov ID
- NCT03388099
- Acronym / sponsor ID
- GREPAMOR / 1706-VLC-058-EB
- Conditions
- antimüllerian Hormone and Gonadotrophin Receptor Polymorphism as Predictors of Ovarian Response
- Keywords
- gonadotrophin receptor polymorphism, antimüllerian hormone, ovarian response, ovarian stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 2 Jan 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.
Aim of study: To compare the relationship between serum AMH and ovarian response for IVF with the GnRH antagonist protocol in patients who are carriers of FSH and/or LH receptor polymorphisms with those that are not.
Detailed description
Serum AMH has shown to have a high predictive capability of the ovarian response to stimulation for IVF. On the other hand, patients who are carriers of polymorphisms in the FSH and LH receptors, have shown to need higher doses of gonadotrophins for ovarian stimulation. The proportion of carriers has been described to be around 20% of the population. Nevertheless, the determination of these polymorphisms is not performed in routine practice. It is unknown if their presence affects to the relationship between serum AMH levels and ovarian response.
This is a prospective, single center, non-interventional, cohorts study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with FSH/LH polymorphisms | – | –Infertile patients will undergo an ovarian stimulation with FSH and/or hMG. Doses will be chosen according to BMI, Antral follicle count, AMH and age. |
| patients without FSH/LH polymorphisms | – | –Infertile patients will undergo an ovarian stimulation with FSH and/or hMG. Doses will be chosen according to BMI, Antral follicle count, AMH and age. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile Patients undergoing IVF treatments
Key inclusion criteria (5 listed)
- 18-45 years of age presenting to IVF clinic
- BMI of 18-35 kg/m2
- Having been tested for serum AMH with the Elecsys assay
- Being planned to undergo ovarian stimulation cycle for IVF with the GnRH antagonist protocol
- Signed written informed consent or waiver
Key exclusion criteria (2 listed)
- Current or past disease affecting ovaries, gonadotropin or sex steroid
- Current hormone therapy
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
Gonadotrophin receptor polymorphisms and ovarian response and AMH value
Time frame: 1 year
To compare the relationship between serum AMH and ovarian response for IVF with the GnRH antagonist protocol in patients who are carriers of FSH and/or LH receptor polymorphisms with those that are not.
3 secondary outcomes
polymorphisms in the FSH receptor (FSHR) variant N680S
Time frame: 1 year
polymorphisms in the LH receptor (LHR) variant N312S
Time frame: 1 year
Doses of gonadotrophin needed and polymorphisms
Time frame: 1 year
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 20 Dec 2019.
- 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.
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 antimüllerian Hormone and Gonadotrophin Receptor Polymorphism as Predictors of Ovarian Response, 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 20 Dec 2019. 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?
Gonadotrophin receptor polymorphisms and ovarian response and AMH value (time frame: 1 year). 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 20 Dec 2019.