InfertilityNCT00767611
Molecular Markers of Human Sperm Function
An observational study of Infertility and Reproduction, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Infertility, Reproduction, Reproductive Techniques, Assisted
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Use of frozen sperm to inseminate eggs. The rationale for this exclusion is that the effect of cryopreservation reagents on PLC zeta activity is unknown, and very few of the ART cycles at DFC utilize donor sperm so we would not be able to control appropriately for this confounder.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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...
Read the detailed description
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 pregnancy outcome. Association of PLC zeta activity with male partner's clinical or laboratory information will be determined. Variability in sperm PLC zeta activity will be determined within and between individuals.
- Conditions
- Infertility, Reproduction, Reproductive Techniques, Assisted
- Keywords
- Infertility, Sperm, Embryo Development, In Vitro Fertilization
- Medical subject headings
- Infertility, Helping Behavior
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startOct 2008
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767611
- Sponsor's protocol ID
- 999909001
- Other IDs
- 09-E-N001
- Status last verified
- May 2012
- First submitted
- 4 Oct 2008
- Last updated
- 10 May 2012
- Results posted
- No
Publications
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.
PubMed 16532609Esfandiari 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.
PubMed 16405104Kouchi 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.
PubMed 14701816
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Markers of Human Sperm Function
- ClinicalTrials.gov ID
- NCT00767611
- Acronym / sponsor ID
- 999909001
- Conditions
- Infertility, Reproduction, Reproductive Techniques, Assisted
- Keywords
- Infertility, Sperm, Embryo Development, In Vitro Fertilization
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- Oct 2008
- Study completion
- Jul 2009 (actual)
- First posted
- 7 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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...
Detailed description
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 pregnancy outcome. Association of PLC zeta activity with male partner's clinical or laboratory information will be determined. Variability in sperm PLC zeta activity will be determined within and between individuals.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
- Use of frozen sperm to inseminate eggs. The rationale for this exclusion is that the effect of cryopreservation reagents on PLC zeta activity is unknown, and very few of the ART cycles at DFC utilize donor sperm so we would not be able to control appropriately for this confounder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2012.
- Background: PubMed 16532609Chandra 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.
- Background: PubMed 16405104Esfandiari 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.
- Background: PubMed 14701816Kouchi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Reproduction, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00767611, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2012.