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

antimüllerian Hormone and Gonadotrophin Receptor Polymorphism as Predictors of Ovarian Response Clinical Trial

— GREPAMOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03388099
• Other study ID #: 1706-VLC-058-EB
• Status: Completed
• Start date: January 11, 2018
• Est. completion date: December 18, 2019

Study information

• Verified date: December 2019
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: December 18, 2019
• Est. primary completion date: December 18, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Spain	Valencian Institute of Infertility, IVI RMA. Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	Doses of gonadotrophin needed and polymorphisms	To analyse the doses of gonadotrophins needed for stimulation on each group of patients	1 year