Status:
COMPLETED
Accuracy of SPD Persona LH Assay When Compared to Ultrasound Observed Ovulation and Other Indices of Ovulation
Lead Sponsor:
SPD Development Company Limited
Conditions:
Ovulation
Eligibility:
FEMALE
18-40 years
Brief Summary
This study will examine the performance of the Persona assays in identifying the time when risk of pregnancy is highest by comparing results to ultrasound observed ovulation and other indices of ovula...
Detailed Description
Persona is a CE marked, natural method of contraception that works by monitoring hormone changes in a woman's urine to identify the days of her menstrual cycle when she is likely to become pregnant fo...
Eligibility Criteria
Inclusion
- Female
- Aged 18 - 40 years
- Menstrual cycle length between 23 and 35 days
- Had two natural cycles prior to study participation
- Using non-hormonal contraception to avoid pregnancy OR abstaining from intercourse for the last three months and the present cycle
- N.B: Non hormonal contraception includes barrier methods such as male and female condoms, diaphragms or caps, non-hormonal intra-uterine devices such as coils, male and female sterilisation or natural family planning
Exclusion
- Unwilling to provide written informed consent to participate in the study or comply with study procedures
- Pregnant
- Breastfeeding
- Has menopausal symptoms such as night sweats or hot flushes
- Using any hormonal treatments e.g. hormonal contraception, fertility treatments and hormone replacement therapy (except thyroxin)
- Taking antibiotics (based on decision by principle investigator)
- Has a diagnosis of polycystic ovarian syndrome (PCOS)
- Has impaired liver or kidney function
- Intending to use PERSONA as a contraceptive during the study period
- Contraindications to frequent blood sampling e.g. anaemia, hypotonia and blood clotting diseases
- Contraindications to frequent ultrasound examinations e.g. morbid obesity and recent abdominal surgery
Key Trial Info
Start Date :
February 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01802060
Start Date
February 1 2013
End Date
November 1 2013
Last Update
December 2 2014
Active Locations (1)
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1
Green-ivf, Rheydter Strasse 143, Grevenboich
Düsseldorf, Germany, 41515