Infertility Clinical Trial
Official title:
Human MATER and Idiopathic Infertility
Verified date | March 29, 2011 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Approximately 15 percent of couples experience infertility, yet no abnormalities can be
detected in the man or the woman. In a number of couples, their embryos unexpectedly slow
down growth or stop growth completely. Some of these situations may be genetically
determined. For instance, a portion of cases may be caused by poor egg quality related to
genetic or functional deficiencies in heretofore unidentified human maternal effect genes. A
model has been developed of such unexplained fertility by creating a mouse line lacking a
critical maternal effect gene. (Maternal effect genes produce mRNA or proteins that
accumulate in the egg and are required for normal early embryonic development.) This pilot
project will test the hypothesis that a similar defect may be a cause of human infertility.
Thirty cubic centimeters of blood will be collected from 40 women who have a clinical history
consistent with a defective maternal effect gene. DNA from these blood cells will be examined
and stored. Some of the blood cells will be treated so that they can be frozen and grown in
the laboratory to produce more DNA in the future. If certain mutations are not found, that
means that the prevalence of such mutations is less than 10 percent, and investigators may
initiate another study with 100 women. If a common mutation is found in at least four
patients, the investigators will seek to collect DNA from 150 normal fertile control women
for comparison.
This project is purely investigational; therefore, findings will not be shared with
participants.
Status | Completed |
Enrollment | 100 |
Est. completion date | March 29, 2011 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
- INCLUSION CRITERIA: Women to be included in this study will have a clinical infertility history that would be consistent with a possible defect in a maternal effect gene. This includes women who meet the following criteria: 1. a clinical diagnosis of infertility, 2. never been pregnant, and 3. undergone treatment by in vitro fertilization and had at least 8 fertilized eggs as part of at least one in vitro fertilization cycle that failed to lead to a clinical pregnancy. Women who have subsequently achieved a pregnancy by egg donation will be included. Women of any age are eligible as long as they have otherwise met the inclusion criteria. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Collins JA, Crosignani PG. Unexplained infertility: a review of diagnosis, prognosis, treatment efficacy and management. Int J Gynaecol Obstet. 1992 Dec;39(4):267-75. Review. — View Citation
Greenhouse S, Rankin T, Dean J. Genetic causes of female infertility: targeted mutagenesis in mice. Am J Hum Genet. 1998 Jun;62(6):1282-7. Review. — View Citation
Schultz RM. Regulation of zygotic gene activation in the mouse. Bioessays. 1993 Aug;15(8):531-8. Review. — View Citation
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