Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Genetic Variation in Gonadotropin and Gonadotropin Receptor Genes and Suboptimal Response

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03007043
Recruitment Status : Completed
First Posted : December 30, 2016
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Nikolaos Polyzos, Institut Universitari Dexeus

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

Condition or disease Intervention/treatment
Fertility Disorders Other: blood sample

Layout table for study information
Study Type : Observational
Actual Enrollment : 364 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genetic Variation in Gonadotropin and Gonadotropin Receptor Genes as a Causative Factor of Suboptimal Response Following Ovarian Stimulation for IVF/ICSI. A Prospective Cohort Study
Study Start Date : November 2016
Actual Primary Completion Date : April 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Normal responders
Normal response following IVF
Other: blood sample
Suboptimal responders
Suboptimal response following IVF
Other: blood sample



Primary Outcome Measures :
  1. prevalence of the main FSH receptor polymorphism [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Infertile women undergoing ovarian stimulation
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03007043


Locations
Layout table for location information
Spain
Dexeus Salud de la Mujer
Barcelona, Spain
Vietnam
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
Sponsors and Collaborators
Institut Universitari Dexeus
Layout table for additonal information
Responsible Party: Nikolaos Polyzos, Professor, Institut Universitari Dexeus
ClinicalTrials.gov Identifier: NCT03007043    
Other Study ID Numbers: 2016.Polymorphisms_COS
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020