Molecular Markers of Human Sperm Function

NCT00767611 | Withdrawn

• 2 other identifiers: 99990900109-E-N001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: Male factor infertility is poorly understood and our ability to evaluate the male contribution to a couple's infertility is very limited. The overarching goal of this project is to understand at the molecular level what functional activities in human sperm are required for successful fertilization leading to full term development. These findings will allow us to develop new methods to determine the impact of environmental exposures on sperm quality and male fertility. A sperm protein known as phospholipase C zeta (PLC zeta) initiates embryo development at fertilization. The primary objective of this study is to test the hypothesis that human PLC zeta activity correlates directly with the proportion of fertilized eggs that undergo early cleavage during an in vitro fertilization (IVF) cycle. Secondary objectives for the study are to generate preliminary data regarding the variability in sperm PLC zeta activity within and between individuals and to determine if there are clinical or laboratory correlates for sperm PLC zeta activity. Study population: The study population will consist of 178 infertile couples undergoing IVF procedures at Duke Fertility Center (DFC) from which we will obtain 154 evaluable couples for the study. Overall Design: An observational cohort study design will be used to assess the association of PLC zeta activity in the residual sperm from the sample used for an IVF cycle with the proportion of eggs per couple that undergo early cleavage during the same cycle. Infertile couples enrolling in an IVF treatment cycle at DFC will be approached for inclusion in the study. Consent will be obtained from both male and female partners, and historical medical information and information about their IVF cycle will be collected by chart review. Blood for isolation of serum and DNA will be collected only from the male partner for evaluation of hormone levels and genetic analyses related to infertility. On the day of the egg retrieval, residual sperm not needed for clinical purposes will be transported via courier to NIEHS. Sperm PLC zeta activity will be measured in the investigator's laboratory using an experimental bioassay. Sperm PLC zeta protein will be analyzed at the University of Massachusetts. Outcome Parameters: The primary outcome will be the proportion of embryos that undergo early cleavage. Secondary outcomes will include proportion of eggs fertilized, embryo development parameters, and p...

Conditions

Infertility; Reproduction; Reproductive Techniques, Assisted

Keywords

Infertility; Sperm; Embryo Development; In Vitro Fertilization

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Infertile couples undergoing an ART cycle at DFC in which eggs are retrieved from the female partner. This type of ART cycle comprises approximately 80-90 percent of the ART cycles at DFC.
• Infertile couples undergoing an ART cycle at DFC in which the eggs are retrieved from an anonymous egg donor. Approximately 10-20 percent of the ART cycles at DFC involve anonymous egg donation.
• Willing and able to provide informed consent.
• Age greater than or equal to 18 (both partners in couple). Essentially all infertile couples who enter clinical ART programs at least age 18.

You may not qualify if:

• Previous completed participation in the study. A complete data set will be obtained from either partner of a couple only once for this study.
• Cancellation of the ART cycle prior to egg retrieval, or no fertilizable eggs retrieved. In this case it would not be possible to determine our primary outcome.
• Age less than 18 (either partner in couple). Because they so rarely experience clinical infertility, we do not expect any couples under age 18 to enter the ART program, so we will not include these as subjects.

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (3)

• Chandra A, Martinez GM, Mosher WD, Abma JC, Jones J. Fertility, family planning, and reproductive health of U.S. women: data from the 2002 National Survey of Family Growth. Vital Health Stat 23. 2005 Dec;(25):1-160.

  PMID: 16532609 BACKGROUND

• Esfandiari N, Javed MH, Gotlieb L, Casper RF. Complete failed fertilization after intracytoplasmic sperm injection--analysis of 10 years' data. Int J Fertil Womens Med. 2005 Jul-Aug;50(4):187-92.

  PMID: 16405104 BACKGROUND

• Kouchi Z, Fukami K, Shikano T, Oda S, Nakamura Y, Takenawa T, Miyazaki S. Recombinant phospholipase Czeta has high Ca2+ sensitivity and induces Ca2+ oscillations in mouse eggs. J Biol Chem. 2004 Mar 12;279(11):10408-12. doi: 10.1074/jbc.M313801200. Epub 2003 Dec 29.

  PMID: 14701816 BACKGROUND

MeSH Terms

Conditions

Infertility; Helping Behavior

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Social Behavior; Behavior

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 4, 2008
• First Posted: October 7, 2008
• Study Start: October 1, 2008
• Study Completion: July 1, 2009
• Last Updated: May 10, 2012

Record last verified: 2012-05

Locations

US (1)