NCT03007043

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

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
364

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Typical duration for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 30, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

2.4 years

First QC Date

December 28, 2016

Last Update Submit

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

Other: blood sample

Suboptimal responders

Suboptimal response following IVF

Other: blood sample

Interventions

Normal respondersSuboptimal responders

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

Study Sites (2)

Dexeus Salud de la Mujer

Barcelona, Spain

Location

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

Location

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.

  • 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.

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

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

Locations