Overview

This trial is active, not recruiting.

Condition healthy
Treatment no intervention
Sponsor University of North Carolina, Chapel Hill
Collaborator Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date April 2008
End date September 2016
Trial size 850 participants
Trial identifier NCT01028365, 1R21HD060229-01A1, UNC-Chapel Hill

Summary

The purpose of this research study is to learn a way to measure a person's fertility. After 1 year of trying, 1 out of every 7 women will not be pregnant. This is called infertility. This results in significant distress and anxiety. Infertility is common; however, the investigators have no markers to predict who will be infertile. For couples diagnosed with infertility, the investigators have used blood and urine hormone levels (follicle stimulating hormone (FSH), inhibin B, and antimullerian hormone (AMH)) to tell us who will get pregnant with fertility treatment. The investigators don't know if these hormone levels can predict if regular people trying to get pregnant will be able to get pregnant. This study will try to determine if these hormone levels can predict fertility and infertility.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Study participants will not be asked to make any changes to their daily lifestyle or existing health care routine. Participants also will not be asked to take any medications or change their diet.
no intervention No intervention
Study participants will not be asked to make any changes to their daily lifestyle or existing health care routine. Participants also will not be asked to take any medications or change their diet.

Primary Outcomes

Measure
Conception
time frame: 12 months, or until conception

Eligibility Criteria

Female participants from 30 years up to 44 years old.

Inclusion Criteria: - women between the ages of 30 and 44 - hoping to get pregnant and about to start trying or have been trying for less than 3 months - living with male partner Exclusion Criteria: - currently using birth control with no intention of stopping - have been trying to get pregnant for more than 3 months - have used hormone shots for birth control in the past year - have renal failure - have known fertility problems, such as polycystic ovarian syndrome (PCOS) - plan on moving outside of the Triangle Area in the next 6 months

Additional Information

Official title Time to Conceive: A Study of Fertility: Biomarkers of Fertility
Principal investigator Anne Z Steiner, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill.