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

NCT ID: NCT03388099

Last Updated: 2019-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

296 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-11

Study Completion Date

2019-12-18

Brief Summary

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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

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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.

Conditions

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antimüllerian Hormone and Gonadotrophin Receptor Polymorphism as Predictors of Ovarian Response

Keywords

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gonadotrophin receptor polymorphism antimüllerian hormone ovarian response ovarian stimulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Valencian Institute of Infertility, IVI RMA. Valencia

Valencia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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1706-VLC-058-EB

Identifier Type: -

Identifier Source: org_study_id