Genetic Variation in Gonadotropin and Gonadotropin Receptor Genes and Suboptimal Response
1 other identifier
observational
364
2 countries
2
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2016
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 28, 2016
CompletedFirst Posted
Study publicly available on registry
December 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJanuary 27, 2020
January 1, 2020
2.4 years
December 28, 2016
January 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
prevalence of the main FSH receptor polymorphism
12 months
Study Arms (2)
Normal responders
Normal response following IVF
Suboptimal responders
Suboptimal response following IVF
Interventions
Eligibility Criteria
Infertile women undergoing ovarian stimulation
You may qualify if:
- Age between 18-38 years old
- BMI 18-28
- Antral follicle count (AFC) \> 9 or Anti-mullerian hormone (AMH) \>1.1 ng/ml
- st or 2nd ovarian stimulation cycle for IVF/ICSI
- Planned to undergo ovarian stimulation with 150IU of rFSH in a fixed GnRH antagonist protocol
You may not qualify if:
- Antral follicle count (AFC) \<9 and AMH\<1.1 ng/ml
- PCOS patients according to the Rotterdam criteria
- Patients undergoing in vitro maturation (IVM)
- Untreated endocrine abnormalities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundacion Dexeuslead
Study Sites (2)
Dexeus Salud de la Mujer
Barcelona, Spain
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
Related Publications (2)
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.
PMID: 36069495DERIVEDPolyzos 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.
PMID: 33889959DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 28, 2016
First Posted
December 30, 2016
Study Start
November 1, 2016
Primary Completion
April 1, 2019
Study Completion
December 1, 2019
Last Updated
January 27, 2020
Record last verified: 2020-01