Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Gonadotrophin REceptor Polimorphisms on the Relationship Between Serum AMH and Ovarian Response (GREPAMOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03388099
Recruitment Status : Completed
First Posted : January 2, 2018
Last Update Posted : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
Instituto Valenciano de Infertilidad, IVI VALENCIA

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease
antimüllerian Hormone and Gonadotrophin Receptor Polymorphism as Predictors of Ovarian Response

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 296 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Gonadotrophin REceptor Polimorphisms on the Relationship Between Serum AMH and Ovarian Response
Actual Study Start Date : January 11, 2018
Actual Primary Completion Date : December 18, 2019
Actual Study Completion Date : December 18, 2019
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. polymorphisms in the FSH receptor (FSHR) variant N680S [ Time Frame: 1 year ]
    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.

  2. polymorphisms in the LH receptor (LHR) variant N312S [ Time Frame: 1 year ]
    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.

  3. Doses of gonadotrophin needed and polymorphisms [ Time Frame: 1 year ]
    To analyse the doses of gonadotrophins needed for stimulation on each group of patients


Biospecimen Retention:   Samples With DNA
Whole blood samples

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only women will undergo an ovarian stimulation for IVF treatment
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infertile Patients undergoing IVF treatments
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Current or past disease affecting ovaries, gonadotropin or sex steroid
  • Current hormone therapy
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388099


Locations
Layout table for location information
Spain
Valencian Institute of Infertility, IVI RMA. Valencia
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier: NCT03388099    
Other Study ID Numbers: 1706-VLC-058-EB
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Instituto Valenciano de Infertilidad, IVI VALENCIA:
gonadotrophin receptor polymorphism
antimüllerian hormone
ovarian response
ovarian stimulation