InfertilityNCT00642590
Lifestyle and Fertility Study on Antioxidant Status, Diet and Early Pregnancy
An observational study of Infertility and Pregnancy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
Trial summary
Researchers believe that certain lifestyle factors can influence a couple's ability to conceive and have a baby. The ISIS Study will look at the health habits of couples who are planning their first pregnancy, and then attempt to measure the effect these habits have on the couple's fertility. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility, Pregnancy, Fertility
- How many people
- 266 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2008to Oct 2020
- 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 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: We are looking for couples who are planning a pregnancy. This must be a first pregnancy for women, ages 18 to 39, and both partners must be in good general health with no history of infertility.
Who may be able to join
- Female is between 18 and 39 years of age
- Female is having regular periods
- Couple is currently using some form of contraception (e.g., oral contraceptives, barrier methods, timing method), but planning to get pregnant in the near future.
Who cannot join
- Female has a previous pregnancy
- Female has tried for 12 months or more to achieve a pregnancy without success, or has undergone fertility treatment
- Female has received a diagnosis of polycystic ovary syndrome (PCOS)
- Female has another serious medical condition (e.g. heart disease, kidney disease, diabetes, thyroid disease, clinical depression, or an acute chronic infection)
- Male has tried for 12 months or more to achieve a conception without success
- Male has had a fertility related condition (e.g., zoo- or oligospermia, other abnormal semen analysis, cryptorchidism, or testicular cancer)
- Male has another serious medical condition (e.g. heart disease, kidney disease, diabetes, thyroid disease, clinical depression, or an acute chronic infection)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Marlene Goldman
Concord, New Hampshire, 03301
Penn State University
University Park, Pennsylvania, 16802
About this study
Official title: Antioxidant Status, Diet and Early Pregnancy
Researchers believe that certain lifestyle factors can influence a couple's ability to conceive and have a baby. The ISIS Study will look at the health habits of couples who are planning their first pregnancy, and then attempt to measure the effect these habits have on the couple's fertility. The ISIS Study hopes to clarify the link between lifestyle and fertility, and believes that information gained in this project may help future couples in their attempts to conceive.
Read the detailed description
Only one-fourth to one-third of fertilized human eggs are likely to survive to produce a term baby. The causes of these reproductive failures are substantially unknown, but scientific evidence suggests that they may, in part, be due to exposures such as pre-conception nutrition, that may result in insults to the oocyte and periconceptual embryo. Early reproductive events may have long-lasting impact as several have recently been identified as antecedents to adult-onset diseases. The goal of this prospective epidemiologic study is to evaluate the hypothesis that increased oxidative stress results in delayed time-to-pregnancy or early pregnancy loss. Recently, reactive oxygen species (ROS) have been associated with spontaneous abortion, preeclampsia, and premature preterm rupture of the membranes in women and defective sperm function in men. In living cells ROS are formed continuously as a consequence of both biochemical reactions and external factors. In this prospective cohort study of healthy couples who are planning pregnancy, we are evaluating time-to-pregnancy, defined as the number of menstrual cycles from the cessation of contraception to a clinically recognized pregnancy, and early unrecognized pregnancy loss. Unrecognized pregnancy and subsequent early loss will be determined by measuring urinary human chorionic gonadotropin (hCG). Diet will be assessed in both partners prior to conception using the Block food frequency questionnaire and serum assays for the antioxidants vitamins C and E, the carotenoids, and selenium. Two urinary biomarkers of oxidative stress, 8-hydroxy-2'-deoxyguanosine and F2a-isoprostanes, and a serum biomarker of antioxidative capacity, oxygen radical absorbance capacity, will be measured in the women. The proposed study has a number of strengths: 1) it is large and prospective in design, with diet and oxidative stress measured prior to conception; 2) a highly sensitive and specific assay for hCG will be used to detect conceptions as early as the time of implantation; 3) dietary intake and biomarker assays of antioxidant status will be assessed twice during the preconception period using state-of-the-art assessment methods including a diet calibration substudy; 4) the proposed research has the potential to fill gaps in our understanding of the role of diet in achieving successful conception, an area where very little investigation has been done.
- Conditions
- Infertility, Pregnancy, Fertility, Nutrition, Life Style
- Keywords
- Fertility, Pregnancy, Conception, Infertility, Behavioral, Lifestyle, Nutrition
- Medical subject headings
- Infertility, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Healthy nulliparous women ages 18-39 and their male partners were enrolled at one of four enrollment sites in the United States. Dietary and supplemental intake were assessed using 24-hour dietary recalls. Couples were followed to determine time to pregnancy and pregnancy outcome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to pregnancy
Time to pregnancy is defined as the number of menstrual cycles from the cessation of contraception to a clinically recognized pregnancy.
Measured: Couples will be followed from preconception to the outcome of pregnancy.
Early pregnancy loss
Pregnancy and subsequent early loss will be determined by measuring urinary human chorionic gonadotropin (hCG).
Measured: First trimester of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2016
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Dartmouth College, Penn State University, Tufts University, Emory University
- Responsible party
- Sponsor
- Investigators
- Marlene B. Goldman, ScD, Principal investigator, Geisel Medical School at Dartmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642590
- Sponsor's protocol ID
- R01HD049762
- Status last verified
- May 2026
- First submitted
- 21 Mar 2008
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Ruder EH, Hartman TJ, Blumberg J, Goldman MB. Oxidative stress and antioxidants: exposure and impact on female fertility. Hum Reprod Update. 2008 Jul-Aug;14(4):345-57. doi: 10.1093/humupd/dmn011. Epub 2008 Jun 4.
PubMed 18535004Paine MA, Ruder EH, Hartman TJ, Blumberg J, Goldman MB. Oxidative stress, oogenesis, and folliculogenesis. In: Studies on Women's Health. Oxidative Stress in Applied Basic Research and Clinical Practice. Agarwal A, Aziz N, Rizk B (eds.), Studies on Women's Health. New York: Springer, 2013.
Ruder EH, Hartman TJ, Goldman MB. Impact of oxidative stress on female fertility. Curr Opin Obstet Gynecol. 2009 Jun;21(3):219-22. doi: 10.1097/gco.0b013e32832924ba.
PubMed 19469044Darche RL, Ruder EH, Blumberg J, Hartman TJ, Goldman MB. Antioxidants in reproductive health and fertility. In Al-Gubory KH, Laher I (eds). Nutritional Antioxidant Therapies: Treatments and Perspectives. Springer-Verlag (Germany), 2017. https://doi.org/10.1007/978-3-319-676258.
Patchell FS, Ruder EH, Mitchell DC, Hartman TJ, Goldman MB. A comparison of energy and antioxidant intake using the Block FFQ and unannounced 24-hour recalls among couples planning pregnancy. 7th International Conference on Diet and Activity Methods, June 4-7, 2009, Washington, DC.
Patchell FS, Ruder EH, Mitchell DC, Jacques PF, Hartman TJ, Goldman MB. A comparison of selected nutrient intakes between the Block FFQ and unannounced 24-hour dietary recalls in periconceptional couples. Experimental Biology, Washington, DC, April 9-13, 2011.
Ruder EH, Hartman TJ, Reindollar RH, Goldman MB. Female dietary antioxidant intake and time to pregnancy among couples treated for unexplained infertility. Fertil Steril. 2014 Mar;101(3):759-66. doi: 10.1016/j.fertnstert.2013.11.008. Epub 2013 Dec 17.
PubMed 24355050Pacis MM, Goldman MB, Fung JL, Reindollar RH. Is there an association between Vitamin D intake and time to conception? Data from the FASTT trial. American Society for Reproductive Medicine, Boston, MA, October 12-17, 2013.
Hsiao PY, Fung JL, Mitchell DC, Hartman TJ, Goldman MB. Dietary quality in nulliparous women planning pregnancy: results from the ISIS study. Experimental Biology 2015, Boston, MA, March 28-April 1, 2015.
Goldman MB, Fung JL, Blumberg J, Hartman TJ. Antioxidant intake, oxidative stress, and pregnancy: results from the lifestyle and fertility study (ISIS). Reprod Sci 2016:23 (Suppl 1);186A.
Fung JL, Hartman TJ, Schleicher RL, Goldman MB. Association of vitamin D intake and serum levels with fertility: results from the Lifestyle and Fertility Study. Fertil Steril. 2017 Aug;108(2):302-311. doi: 10.1016/j.fertnstert.2017.05.037. Epub 2017 Jun 16.
PubMed 28629584Hsiao PY, Fung JL, Mitchell DC, Hartman TJ, Goldman MB. Dietary quality, as measured by the Alternative Healthy Eating Index for Pregnancy (AHEI-P), in couples planning their first pregnancy. Public Health Nutr. 2019 Dec;22(18):3385-3394. doi: 10.1017/S1368980019001290. Epub 2019 May 27.
PubMed 31131783Hartman TJ, Fung JL, Hsiao PY, Fan W, Mitchell DC, Goldman MB. Dietary Energy Density and Fertility: Results from the Lifestyle and Fertility Study. Curr Dev Nutr. 2021 Apr 28;5(5):nzab075. doi: 10.1093/cdn/nzab075. eCollection 2021 May.
PubMed 34084994Goldman MB, Fung JL, Blumberg J, Mitchell DC, Hartman JL. Antioxidant status in women planning a first pregnancy: results from the Lifestyle and Fertility Study. Submitted.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antioxidant Status, Diet and Early Pregnancy
- ClinicalTrials.gov ID
- NCT00642590
- Acronym / sponsor ID
- R01HD049762
- Conditions
- Infertility, Pregnancy, Fertility, Nutrition, Life Style
- Keywords
- Fertility, Pregnancy, Conception, Infertility, Behavioral, Lifestyle, Nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Collaborators
- Dartmouth College, Penn State University, Tufts University, Emory University
- Study start
- Mar 2008 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 25 Mar 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.
Researchers believe that certain lifestyle factors can influence a couple's ability to conceive and have a baby. The ISIS Study will look at the health habits of couples who are planning their first pregnancy, and then attempt to measure the effect these habits have on the couple's fertility. The ISIS Study hopes to clarify the link between lifestyle and fertility, and believes that information gained in this project may help future couples in their attempts to conceive.
Detailed description
Only one-fourth to one-third of fertilized human eggs are likely to survive to produce a term baby. The causes of these reproductive failures are substantially unknown, but scientific evidence suggests that they may, in part, be due to exposures such as pre-conception nutrition, that may result in insults to the oocyte and periconceptual embryo. Early reproductive events may have long-lasting impact as several have recently been identified as antecedents to adult-onset diseases. The goal of this prospective epidemiologic study is to evaluate the hypothesis that increased oxidative stress results in delayed time-to-pregnancy or early pregnancy loss. Recently, reactive oxygen species (ROS) have been associated with spontaneous abortion, preeclampsia, and premature preterm rupture of the membranes in women and defective sperm function in men. In living cells ROS are formed continuously as a consequence of both biochemical reactions and external factors. In this prospective cohort study of healthy couples who are planning pregnancy, we are evaluating time-to-pregnancy, defined as the number of menstrual cycles from the cessation of contraception to a clinically recognized pregnancy, and early unrecognized pregnancy loss. Unrecognized pregnancy and subsequent early loss will be determined by measuring urinary human chorionic gonadotropin (hCG). Diet will be assessed in both partners prior to conception using the Block food frequency questionnaire and serum assays for the antioxidants vitamins C and E, the carotenoids, and selenium. Two urinary biomarkers of oxidative stress, 8-hydroxy-2'-deoxyguanosine and F2a-isoprostanes, and a serum biomarker of antioxidative capacity, oxygen radical absorbance capacity, will be measured in the women. The proposed study has a number of strengths: 1) it is large and prospective in design, with diet and oxidative stress measured prior to conception; 2) a highly sensitive and specific assay for hCG will be used to detect conceptions as early as the time of implantation; 3) dietary intake and biomarker assays of antioxidant status will be assessed twice during the preconception period using state-of-the-art assessment methods including a diet calibration substudy; 4) the proposed research has the potential to fill gaps in our understanding of the role of diet in achieving successful conception, an area where very little investigation has been done.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Healthy nulliparous women ages 18-39 and their male partners were enrolled at one of four enrollment sites in the United States. Dietary and supplemental intake were assessed using 24-hour dietary recalls. Couples were followed to determine time to pregnancy and pregnancy outcome. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- We are looking for couples who are planning a pregnancy. This must be a first pregnancy for women, ages 18 to 39, and both partners must be in good general health with no history of infertility.
Key inclusion criteria (3 listed)
- Female is between 18 and 39 years of age
- Female is having regular periods
- Couple is currently using some form of contraception (e.g., oral contraceptives, barrier methods, timing method), but planning to get pregnant in the near future.
Key exclusion criteria (7 listed)
- Female has a previous pregnancy
- Female has tried for 12 months or more to achieve a pregnancy without success, or has undergone fertility treatment
- Female has received a diagnosis of polycystic ovary syndrome (PCOS)
- Female has another serious medical condition (e.g. heart disease, kidney disease, diabetes, thyroid disease, clinical depression, or an acute chronic infection)
- Male has tried for 12 months or more to achieve a conception without success
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
Time to pregnancy
Time frame: Couples will be followed from preconception to the outcome of pregnancy.
Time to pregnancy is defined as the number of menstrual cycles from the cessation of contraception to a clinically recognized pregnancy.
Early pregnancy loss
Time frame: First trimester of pregnancy
Pregnancy and subsequent early loss will be determined by measuring urinary human chorionic gonadotropin (hCG).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Background: PubMed 18535004Ruder EH, Hartman TJ, Blumberg J, Goldman MB. Oxidative stress and antioxidants: exposure and impact on female fertility. Hum Reprod Update. 2008 Jul-Aug;14(4):345-57. doi: 10.1093/humupd/dmn011. Epub 2008 Jun 4.
- BackgroundPaine MA, Ruder EH, Hartman TJ, Blumberg J, Goldman MB. Oxidative stress, oogenesis, and folliculogenesis. In: Studies on Women's Health. Oxidative Stress in Applied Basic Research and Clinical Practice. Agarwal A, Aziz N, Rizk B (eds.), Studies on Women's Health. New York: Springer, 2013.
- Background: PubMed 19469044Ruder EH, Hartman TJ, Goldman MB. Impact of oxidative stress on female fertility. Curr Opin Obstet Gynecol. 2009 Jun;21(3):219-22. doi: 10.1097/gco.0b013e32832924ba.
- BackgroundDarche RL, Ruder EH, Blumberg J, Hartman TJ, Goldman MB. Antioxidants in reproductive health and fertility. In Al-Gubory KH, Laher I (eds). Nutritional Antioxidant Therapies: Treatments and Perspectives. Springer-Verlag (Germany), 2017. https://doi.org/10.1007/978-3-319-676258.
- Results publicationPatchell FS, Ruder EH, Mitchell DC, Hartman TJ, Goldman MB. A comparison of energy and antioxidant intake using the Block FFQ and unannounced 24-hour recalls among couples planning pregnancy. 7th International Conference on Diet and Activity Methods, June 4-7, 2009, Washington, DC.
- Results publicationPatchell FS, Ruder EH, Mitchell DC, Jacques PF, Hartman TJ, Goldman MB. A comparison of selected nutrient intakes between the Block FFQ and unannounced 24-hour dietary recalls in periconceptional couples. Experimental Biology, Washington, DC, April 9-13, 2011.
- Results publication: PubMed 24355050Ruder EH, Hartman TJ, Reindollar RH, Goldman MB. Female dietary antioxidant intake and time to pregnancy among couples treated for unexplained infertility. Fertil Steril. 2014 Mar;101(3):759-66. doi: 10.1016/j.fertnstert.2013.11.008. Epub 2013 Dec 17.
- Results publicationPacis MM, Goldman MB, Fung JL, Reindollar RH. Is there an association between Vitamin D intake and time to conception? Data from the FASTT trial. American Society for Reproductive Medicine, Boston, MA, October 12-17, 2013.
- Results publicationHsiao PY, Fung JL, Mitchell DC, Hartman TJ, Goldman MB. Dietary quality in nulliparous women planning pregnancy: results from the ISIS study. Experimental Biology 2015, Boston, MA, March 28-April 1, 2015.
- Results publicationGoldman MB, Fung JL, Blumberg J, Hartman TJ. Antioxidant intake, oxidative stress, and pregnancy: results from the lifestyle and fertility study (ISIS). Reprod Sci 2016:23 (Suppl 1);186A.
- Results publication: PubMed 28629584Fung JL, Hartman TJ, Schleicher RL, Goldman MB. Association of vitamin D intake and serum levels with fertility: results from the Lifestyle and Fertility Study. Fertil Steril. 2017 Aug;108(2):302-311. doi: 10.1016/j.fertnstert.2017.05.037. Epub 2017 Jun 16.
- Results publication: PubMed 31131783Hsiao PY, Fung JL, Mitchell DC, Hartman TJ, Goldman MB. Dietary quality, as measured by the Alternative Healthy Eating Index for Pregnancy (AHEI-P), in couples planning their first pregnancy. Public Health Nutr. 2019 Dec;22(18):3385-3394. doi: 10.1017/S1368980019001290. Epub 2019 May 27.
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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.
Marlene B. Goldman, ScD principal investigator
Geisel Medical School at Dartmouth
2 sites 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 Pregnancy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Time to pregnancy (time frame: Couples will be followed from preconception to the outcome of pregnancy.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00642590, which also lists 14 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 18 May 2026.