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OpenTrials
Completed

NCT Number: NCT03388099

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

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.

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Key information

Conditions

antimüllerian Hormone and Gonadotrophin Receptor Polymorphism as Predictors of Ovarian Response

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Valencian Institute of Infertility, IVI RMA. Valencia

Valencia, 46015, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Other

Registry information

Acronym: GREPAMOR

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2018
Registry last updated
Dec 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.