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

December 19, 2019 updated by: Instituto Valenciano de Infertilidad, IVI VALENCIA
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

296

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46015
        • Valencian Institute of Infertility, IVI RMA. Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Infertile Patients undergoing IVF treatments

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
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.
1 year
Doses of gonadotrophin needed and polymorphisms
Time Frame: 1 year
To analyse the doses of gonadotrophins needed for stimulation on each group of patients
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2018

Primary Completion (Actual)

December 18, 2019

Study Completion (Actual)

December 18, 2019

Study Registration Dates

First Submitted

December 22, 2017

First Submitted That Met QC Criteria

December 22, 2017

First Posted (Actual)

January 2, 2018

Study Record Updates

Last Update Posted (Actual)

December 20, 2019

Last Update Submitted That Met QC Criteria

December 19, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1706-VLC-058-EB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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