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

Completed

• Conditions: antimüllerian Hormone and Gonadotrophin Receptor Polymorphism as Predictors of Ovarian Response

• Registration Number: NCT03388099
• Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

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.

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 Timeline

• Study First Submitted: 2017-12-22
• Study First Submitted QC: 2017-12-22
• Study First Posted: 2018-01-02
• Study Start: 2018-01-11
• Status Verified: 2019-12
• Primary Completion: 2019-12-18
• Study Completion: 2019-12-18
• Last Update Submitted: 2019-12-19
• Last Update Posted: 2019-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 296

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gonadotrophin receptor polymorphisms and ovarian response and AMH value	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

Name	Time	Method
polymorphisms in the LH receptor (LHR) variant N312S	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.
Doses of gonadotrophin needed and polymorphisms	1 year	To analyse the doses of gonadotrophins needed for stimulation on each group of patients
polymorphisms in the FSH receptor (FSHR) variant N680S	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.

Trial Locations

Locations (1)

Valencian Institute of Infertility, IVI RMA. Valencia; 🇪🇸 Valencia, Spain