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CompletedNCT03388099GREPAMORUpdated Dec 20, 2019

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

An observational study in antimüllerian Hormone and Gonadotrophin Receptor Polymorphism as Predictors of Ovarian Response, sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA. Completed at 1 site in Spain. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-12-20.

Sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
296
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • gonadotrophin receptor polymorphism
  • antimüllerian hormone
  • ovarian response
  • ovarian stimulation
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Infertile Patients undergoing IVF treatments

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

Exclusion Criteria:

  • Current or past disease affecting ovaries, gonadotropin or sex steroid
  • Current hormone therapy
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
296 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

Secondary outcomes

  1. 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.

    Time frame: 1 year

  2. 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.

    Time frame: 1 year

  3. Doses of gonadotrophin needed and polymorphisms

    To analyse the doses of gonadotrophins needed for stimulation on each group of patients

    Time frame: 1 year

06

Study locations

1 site
  • Valencian Institute of Infertility, IVI RMA. Valencia
    Valencia, 46015, Spain
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03388099
Lead sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
Responsible party
Sponsor
First posted
Jan 2, 2018
Start date
Jan 11, 2018
Primary completion
Dec 18, 2019
Completion
Dec 18, 2019
Last update
Dec 20, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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