NCT01577147

Brief Summary

Female volunteers, wishing to become pregnant will be offered the use of Clearblue ovulation prediction products to help identify their most fertile time and aid conception. Volunteers will provide SPD with a daily urine sample throughout the study period, which will be used for the development and validation of SPD products related to pregnancy and fertility.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,025

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 13, 2012

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

December 22, 2017

Status Verified

November 1, 2016

Enrollment Period

5.2 years

First QC Date

April 11, 2012

Last Update Submit

December 20, 2017

Conditions

Pregnancy

Keywords

pregnancy

Outcome Measures

Primary Outcomes (1)

  • Collection of early pregnancy urine samples.

    Volunteers who become pregnant during the study will continue to collect daily urine samples until day 60 of the conception cycle.

    60 days

Study Arms (1)

sample collection

OTHER

Ovulation prediction products provided to aid conception

Other: Ovulation predictions products

Interventions

Ovulation predictions productsOTHER

Home diagnostics for ovulation prediction will be provided to study volunteers

sample collection

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female, age 18-45
  • Have menstrual bleeds
  • Seeking to become pregnant
  • Willing to provide written, informed consent

You may not qualify if:

  • Known condition to contra-indicate pregnancy
  • Having treatment for infertility.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SPD Development Company Ltd

Bedford, Bedfordshire, MK44 3UP, United Kingdom

Location

Related Publications (2)

  • Gadsby R, Ivanova D, Trevelyan E, Hutton JL, Johnson S. The onset of nausea and vomiting of pregnancy: a prospective cohort study. BMC Pregnancy Childbirth. 2021 Jan 6;21(1):10. doi: 10.1186/s12884-020-03478-7.

    PMID: 33407214DERIVED

  • Johnson S, Marriott L, Zinaman M. Can apps and calendar methods predict ovulation with accuracy? Curr Med Res Opin. 2018 Sep;34(9):1587-1594. doi: 10.1080/03007995.2018.1475348. Epub 2018 May 25.

    PMID: 29749274DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2012

First Posted

April 13, 2012

Study Start

January 1, 2012

Primary Completion

March 1, 2017

Study Completion

September 1, 2017

Last Updated

December 22, 2017

Record last verified: 2016-11

Locations

GB(1)