Genetic Variation in Gonadotropin and Gonadotropin Receptor Genes and Suboptimal Response

NCT ID: NCT03007043

Last Updated: 2020-01-27

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

364 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-12-31

Brief Summary

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To evaluate the difference in the prevalence of the main FSHR polymorphism (ASN680Ser), as well as other, less studied, gonadotropin polymorphisms between ovarian response groups, following ovarian stimulation

Detailed Description

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Conditions

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Fertility Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal responders

Normal response following IVF

blood sample

Intervention Type OTHER

Suboptimal responders

Suboptimal response following IVF

blood sample

Intervention Type OTHER

Interventions

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blood sample

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age between 18-38 years old
2. BMI 18-28
3. Antral follicle count (AFC) \> 9 or Anti-mullerian hormone (AMH) \>1.1 ng/ml
4. 1st or 2nd ovarian stimulation cycle for IVF/ICSI
5. Planned to undergo ovarian stimulation with 150IU of rFSH in a fixed GnRH antagonist protocol

Exclusion Criteria

1. Antral follicle count (AFC) \<9 and AMH\<1.1 ng/ml
2. PCOS patients according to the Rotterdam criteria
3. Patients undergoing in vitro maturation (IVM)
4. Untreated endocrine abnormalities
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fundacion Dexeus

OTHER

Sponsor Role lead

Responsible Party

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Nikolaos Polyzos

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dexeus Salud de la Mujer

Barcelona, , Spain

Site Status

Department of Obstetrics and Gynecology, University of Medicine and Pharmacy HCMC, Ho Chi Minh City, Vietnam and Research Center for Genetics and Reproductive Health (CGRH), School of Medicine, Vietnam National University HCMC

Ho Chi Minh City, , Vietnam

Site Status

Countries

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Spain Vietnam

References

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Neves AR, Vuong NL, Blockeel C, Garcia S, Alviggi C, Spits C, Ma PQM, Ho MT, Tournaye H, Polyzos NP. The effect of polymorphisms in FSHR gene on late follicular phase progesterone and estradiol serum levels in predicted normoresponders. Hum Reprod. 2022 Oct 31;37(11):2646-2654. doi: 10.1093/humrep/deac193.

Reference Type DERIVED
PMID: 36069495 (View on PubMed)

Polyzos NP, Neves AR, Drakopoulos P, Spits C, Alvaro Mercadal B, Garcia S, Ma PQM, Le LH, Ho MT, Mertens J, Stoop D, Tournaye H, Vuong NL. The effect of polymorphisms in FSHR and FSHB genes on ovarian response: a prospective multicenter multinational study in Europe and Asia. Hum Reprod. 2021 May 17;36(6):1711-1721. doi: 10.1093/humrep/deab068.

Reference Type DERIVED
PMID: 33889959 (View on PubMed)

Other Identifiers

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2016.Polymorphisms_COS

Identifier Type: -

Identifier Source: org_study_id

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