Accuracy of SPD Persona LH Assay When Compared to Ultrasound Observed Ovulation and Other Indices of Ovulation

NCT01802060 | Completed

• 1 other identifier: PROTOCOL-0449
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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 ovulation.

Conditions

Ovulation

Keywords

Persona; E3G; LH; ovulation

Outcome Measures

Primary Outcomes (1)

• Ultrasound

  Accuracy of the LH urine assay contained within PERSONA at predicting ovulation, by comparing the day of the LH surge with ultrasound observed ovulation

  Participants will be followed for one menstrual cycle, anticipated average of four weeks.

Secondary Outcomes (2)

• Quantitative determination of urinary and serum levels of LH and E3G

  Participants will be followed one menstrual cycle, an anticipated four weeks

• Volunteer recorded BBT and cervical secretion observations.

  Participants will be followed for one menstrual cycle, an anticipated four weeks

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

General Public

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SPD Development Company Limited: lead

Study Sites (1)

Green-ivf, Rheydter Strasse 143, Grevenboich

Düsseldorf, 41515, Germany

Location

Related Publications (2)

• Gnoth C, Roos J, Broomhead D, Schiffner J, Godehardt E, Freundl G, Johnson S. Antimullerian hormone levels and numbers and sizes of antral follicles in regularly menstruating women of reproductive age referenced to true ovulation day. Fertil Steril. 2015 Dec;104(6):1535-43.e1-4. doi: 10.1016/j.fertnstert.2015.08.027. Epub 2015 Sep 15.

  PMID: 26384163 DERIVED

• Johnson S, Weddell S, Godbert S, Freundl G, Roos J, Gnoth C. Development of the first urinary reproductive hormone ranges referenced to independently determined ovulation day. Clin Chem Lab Med. 2015 Jun;53(7):1099-108. doi: 10.1515/cclm-2014-1087.

  PMID: 25720077 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples Serum samples

Study Officials

• Christian Gnoth, Dr

  Green-ivf, Rheydter Strasse 143

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2013
• First Posted: March 1, 2013
• Study Start: February 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 2, 2014

Record last verified: 2014-11

Locations

DE (1)