Genetic Variation in Gonadotropin and Gonadotropin Receptor Genes and Suboptimal Response

January 22, 2020 updated by: Nikolaos Polyzos, Institut Universitari Dexeus

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

364

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Dexeus Salud de la Mujer
  • Vietnam
      • Ho Chi Minh City, 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Infertile women undergoing ovarian stimulation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
prevalence of the main FSH receptor polymorphism
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Universitari Dexeus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

December 28, 2016

First Submitted That Met QC Criteria

December 28, 2016

First Posted (Estimate)

December 30, 2016

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2016.Polymorphisms_COS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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