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Assessment of Stress Levels in Consumers Using Ovulation Tests in Order to Conceive

Swiss Precision Diagnostics (SPD) logo

Swiss Precision Diagnostics (SPD)

Status

Completed

Conditions

Stress

Study type

Observational

Funder types

Industry

Identifiers

NCT01084304
PROTOCOL-0172

Details and patient eligibility

About

Approximately 150 female volunteers wishing to become pregnant will be recruited via web recruitment from around the UK and randomised 1:1 to receive Clearblue Digital ovulation tests (active arm) or no aid to conception (control arm) for 2 full menstrual cycles. All volunteers will complete study questionnaires and provide a urine sample at designated time points though out the menstrual cycle.

A sub-arm to this study, applied the same protocol to women in an infertility treatment setting; Royal Hallamshire Hospital, Sheffield. Additional exclusion criteria were applied to this cohort; had regular menstrual cycles between 25 and 35 days, and who did not have a diagnosis of bilateral or unilateral tubal blockage, documented anovulation or severe male-factor infertility (with <5 million motile sperm per ejaculate). For this arm, the protocol was reviewed by Sheffield Research Ethics Committee 09/H1308/134.

Enrollment

150 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Provide written informed consent to participate in the study and agree to comply with study procedures.
  • Has menstrual bleeds.
  • Seeking to become pregnant.
  • Living in UK

Exclusion criteria

  • Used hormonal contraception within the last 3 months.
  • Currently undergoing fertility treatment or investigation.
  • Diagnosed as infertile following investigations.
  • Drug or alcohol dependency.
  • history of depression, anxiety or panic attacks

Trial design

150 participants in 2 patient groups

Active
Description:
Use of ovulation tests to aid conception
Control
Description:
No ovulation tests to aid conception

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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