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C Terminal Variants of FSH Receptor

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01524588
First Posted: February 2, 2012
Last Update Posted: October 22, 2012
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.
Information provided by:
University Hospital, Tours
  Purpose

Follicle-stimulating hormone (FSH) is used in medically assisted procreation, to induce an ovarian stimulation in women. However, the FSH dose that has to be injected is quite hard to adjust, because an excess of exogenous hormone could lead to very severe complications for patient. This hormone acts on its cognate receptor, the FSHR, present on the granulosa cells surface, and which regulation involve the intra-cytoplasmic carboxy-terminus domain.

The investigators first aimed to research in the c-terminus part of the receptor the presence of allelic variants that could explain the variations of response to FSH stimulation.

The investigators also would want to complete the data already known on a functionally determinant single nucleotide polymorphism on 680 position in the c-terminus part of the hFSHR.

Then, the investigators would analyze the entire sequence of the hFSHR of patients presenting an unusual phenotype in response to FSH treatment, in order to detect a potential mutation involved in the receptor functionality.

The results of this study could allow us to increase our knowledge on the hFSHR physiology and functionality, in order to adjust treatment to the genetic profile of patients.


Condition
Infertility

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: C Terminal Peptide Variants of the Fsh Receptor in Women Involved in an Assisted Reproduction Programm : Mechanistic Approach

Further study details as provided by University Hospital, Tours:

Enrollment: 814
Study Start Date: April 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients involved in an assisted reproduction programm, once engaged in a stimulation protocol
Criteria

Inclusion Criteria:

  • patients above 18 years,
  • entering an IVF cycle
  • informed consent
  • NHS operative

Exclusion Criteria:

  Contacts and Locations
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): NCT01524588


Locations
France
CHRU de Tours
Tours, France, 37000
Sponsors and Collaborators
University Hospital, Tours
Investigators
Principal Investigator: Dominique ROYERE Tours Hospital
  More Information

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT01524588     History of Changes
Other Study ID Numbers: AOHP07-DR/VARFSHR
First Submitted: August 22, 2011
First Posted: February 2, 2012
Last Update Posted: October 22, 2012
Last Verified: October 2012

Keywords provided by University Hospital, Tours:
Genotype
Phenotype
Genotypic Variation Between Patients
Genotypic Phenotypic Relationships

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female


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