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Clinical Trials/NCT01601171
NCT01601171
Recruiting
Not Applicable

The Genetics of Neuroendocrine Reproductive Disorders and of the Cleft Lip and/or Palate

Centre Hospitalier Universitaire Vaudois1 site in 1 country2,000 target enrollmentMarch 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Kallmann Syndrome
Sponsor
Centre Hospitalier Universitaire Vaudois
Enrollment
2000
Locations
1
Primary Endpoint
rare sequence variant(s) in gene(s)
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this study is to explore the genetic basis of reproductive disorders and cleft lip and/or palate.

Detailed Description

The World Health Organization estimates approximately 10% of couples experience some sort of infertility problem. In humans, puberty is the process through which we develop reproductive capacity. The timing of puberty varies greatly in the general population and is influenced by both genetic and environmental factors. In extreme cases of pubertal delay, puberty progresses only partially or not at all and results in the clinical picture of congenital hypogonadotropic hypogonadism (CHH), either accompanied by anosmia in 50% of cases (Kallmann syndrome \[KS\]) or by normal sense of smell (nCHH), with a male: female ratio of 4:1. CHH is due to GnRH deficiency (incidence 1: 4,000-10,000) and result in the failure of sexual maturation and infertility. It is genetically heterogeneous, with multiple patterns of inheritance and several associated loci. In the clinical spectrum of GnRH deficiency, CHH may also be associated with a cleft lip/palate (CL/P) in 5 to 7% of cases. However, this prevalence increases up to 40% in CHH patients carrying a mutation in a CL/P gene, suggesting a genetic overlap between CHH and CL/P. Disorders of puberty have provided insight into the biology of reproduction and genetic technologies have enabled us to deepen understanding in this field. The focus of this study is to better understand the genetic control of puberty and human reproduction as well as its link with CL/P. Increasing understanding of the molecular basis (genes) of inherited reproductive disorders and CL/P may enable investigators to: * improve diagnostic testing and treatments for these problems * develop new diagnostic tests and therapies for patients * enhance counseling for patients and families with reproductive disorders * enhance counseling for patients and families with cleft lip/palate

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
March 2030
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nelly Pitteloud

Professor of Medicine, Chief of Service

Centre Hospitalier Universitaire Vaudois

Eligibility Criteria

Inclusion Criteria

  • (any of the following conditions)
  • hypogonadotropic hypogonadism
  • Kallmann syndrome
  • adult-onset hypogonadotropic hypogonadism
  • hypothalamic amenorrhea
  • polycystic ovarian syndrome
  • primary gonadal failure
  • precocious puberty
  • cleft lip/palate
  • family members of the above groups

Exclusion Criteria

  • acute illness/hospitalization
  • pituitary tumors
  • iron overload (hemochromatosis)
  • infiltrative diseases (sarcoidosis)
  • chronic alcohol abuse
  • illicit drug use
  • anabolic steroid abuse

Outcomes

Primary Outcomes

rare sequence variant(s) in gene(s)

Time Frame: 1 year (ongoing if no variants are identified)

The investigators aim to discover genes associated with reproductive disorders by identifying rare sequence variants (mutations) in patients

Secondary Outcomes

  • functionality of identified rare sequence variants (mutations)(1 year (following variant identification))
  • genotype-phenotype correlation(1 year (following variant identification))
  • mode of inheritance(1 year (following variant identification))

Study Sites (1)

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