NCT01524588

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
814

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 2, 2012

Completed
Last Updated

October 22, 2012

Status Verified

October 1, 2012

Enrollment Period

3 years

First QC Date

August 22, 2011

Last Update Submit

October 19, 2012

Conditions

Infertility

Keywords

GenotypePhenotypeGenotypic Variation Between PatientsGenotypic Phenotypic Relationships

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients involved in an assisted reproduction programm, once engaged in a stimulation protocol

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Tours

Tours, 37000, France

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Dominique ROYERE

    Tours Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 22, 2011

First Posted

February 2, 2012

Study Start

April 1, 2008

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

October 22, 2012

Record last verified: 2012-10

Locations

FR(1)