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NCT03007043 Clinical Trial

Genetic Variation in Gonadotropin and Gonadotropin Receptor Genes and Suboptimal Response

Fertility Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03007043
Other study ID # 2016.Polymorphisms_COS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2016
Est. completion date December 2019

Study information
Verified date January 2020
Source Institut Universitari Dexeus
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 364
Est. completion date December 2019
Est. primary completion date April 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 38 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• blood sample

Locations
Country Name City State
Spain Dexeus Salud de la Mujer Barcelona
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

Sponsors (1)
Lead Sponsor Collaborator
Institut Universitari Dexeus

Countries where clinical trial is conducted

Spain,  Vietnam, 

Outcome
Type Measure Description Time frame Safety issue
Primary prevalence of the main FSH receptor polymorphism 12 months
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