NCT00341120

Brief Summary

This study is being conducted at the University Hospital of Lund University in Malmo, Sweden, in collaboration with the U.S. National Institute of Child Health and Human Development. The study will try to identify genetic causes of impaired sperm production and male infertility. It will focus on the possible role of the MTHFR and CBS genes, which regulate absorption and metabolism of the vitamin, folate in infertility. If the nutritional intake or metabolism of this vitamin is related to male infertility, then this cause of infertility would be potentially curable. Fertile and infertile men between 20 and 45 years of age may be eligible for this study. Criteria include the following:

  • Fertile men: men whose partners are younger than age 40 and are attending Lund University prenatal clinic; who have fathered one or more pregnancies and who stopped birth control to achieve the present pregnancy; who achieved the present pregnancy in less than 12 months of unprotected intercourse.
  • Infertile men: men referred to the Scandian Andrology Centre whose infertility is unexplained, whose partners are younger than age 40 and who have had regular sexual intercourse without contraception for at least 12 months without achieving a pregnancy. All participants will have the following tests and procedures:
  • Complete a questionnaire providing information about their reproductive and medical history and recent dietary history;
  • Provide blood samples for analysis of red cell folate, plasma folate, plasma homocysteine, plasma B12, and for genetic evaluation;
  • Provide a semen sample for routine analysis, including volume, sperm concentration, sperm motility, and sperm morphology. In addition, infertile men will undergo a physical examination and review of their medical records.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2003

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2003

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2012

Completed
Last Updated

April 5, 2018

Status Verified

August 29, 2012

First QC Date

June 19, 2006

Last Update Submit

April 4, 2018

Conditions

Male Infertility

Keywords

GenotypesMutationFolateMale InfertilityNutrition

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Referred to the Scanian Andrology Centre.
  • Age 20-45.
  • Partner age less than 40.
  • Having had regular sexual intercourse without contraception for a year or more without achieving a pregnancy.

You may not qualify if:

  • Klinefelters syndrome.
  • Hypogondotropic hypogonadism.
  • Y-chromosome microdeletion or abnormality.
  • Other genetic cause for infertility.
  • Obstructive azoospermia.
  • Partner with salpingitis.
  • Partner with polycystic ovarian syndrome.
  • Partner with disturbance of ovulation.
  • Partner with endometriosis.
  • History of cancer.
  • History of treatment with cytotoxic drugs, irradiation, or sulfasalazopyrine.
  • History of cryptorchidism.
  • History of mumps orchitis.
  • History of vasectomy.
  • Partner attending Lund University prenatal clinic.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malmo University Hospital

Malmo, Sweden

Location

Related Publications (3)

  • Ma K, Mallidis C, Bhasin S. The role of Y chromosome deletions in male infertility. Eur J Endocrinol. 2000 May;142(5):418-30. doi: 10.1530/eje.0.1420418.

    PMID: 10802517BACKGROUND

  • Ford WC. Biological mechanisms of male infertility. Lancet. 2001 Apr 21;357(9264):1223-4. doi: 10.1016/s0140-6736(00)04452-4. No abstract available.

    PMID: 11418145BACKGROUND

  • Ruiz-Pesini E, Lapena AC, Diez-Sanchez C, Perez-Martos A, Montoya J, Alvarez E, Diaz M, Urries A, Montoro L, Lopez-Perez MJ, Enriquez JA. Human mtDNA haplogroups associated with high or reduced spermatozoa motility. Am J Hum Genet. 2000 Sep;67(3):682-96. doi: 10.1086/303040. Epub 2000 Aug 9.

    PMID: 10936107BACKGROUND

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Richard J Levine, M.D.

    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

January 2, 2003

Study Completion

August 29, 2012

Last Updated

April 5, 2018

Record last verified: 2012-08-29

Locations

SE(1)