NCT00642590

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
266

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2008

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

March 1, 2008

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2008

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

8.8 years

First QC Date

March 21, 2008

Last Update Submit

March 30, 2016

Conditions

InfertilityPregnancyFertilityNutritionLife Style

Keywords

FertilityPregnancyConceptionInfertilityBehavioralLifestyleNutrition

Outcome Measures

Primary Outcomes (2)

  • Time to pregnancy

    Time to pregnancy is defined as the number of menstrual cycles from the cessation of contraception to a clinically recognized pregnancy.

    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).

    First trimester of pregnancy

Study Arms (1)

1

Healthy couples who are planning their first pregnancy.

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Penn State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (12)

  • 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.

    PMID: 18535004BACKGROUND

  • Paine 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.), Humana Press, 2013.

    BACKGROUND

  • 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.

    PMID: 19469044BACKGROUND

  • Darche 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), in press.

    BACKGROUND

  • 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.

    RESULT

  • 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.

    RESULT

  • 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.

    PMID: 24355050RESULT

  • Pacis 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.

    RESULT

  • 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.

    RESULT

  • 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.

    RESULT

  • 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.

    PMID: 28629584RESULT

  • Hsiao 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.

    PMID: 31131783RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma, serum, urine

MeSH Terms

Conditions

InfertilityBehavior

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Marlene B. Goldman, MS, ScD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2008

First Posted

March 25, 2008

Study Start

March 1, 2008

Primary Completion

December 1, 2016

Study Completion

November 1, 2017

Last Updated

March 31, 2016

Record last verified: 2016-03

Locations

US(2)