FertilityNCT02772848
Fertility in Healthy Premenopausal Women
An observational study of Fertility, run by Fujirebio Diagnostics, Inc. at 2 sites in United States.
Trial summary
The study objectives are described below: 1. Obtain serum specimens collected for one ovulatory cycle or a maximum of 33 days, but not to exceed a total of 550 ml of whole blood per subject from a minimum of 60 healthy, premenopausal subjects. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2016to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: A minimum of 60 subjects will be enrolled in this study. Healthy, premenopausal women greater than or equal to 21 years of age having donated a serial blood collection throughout a single ovulation cycle or a maximum of 33 days will be eligible. Each site or mobile center will evaluate and select patients for enrollment using the inclusion and exclusion criteria listed below. Study subjects should be selected from all available patients at the site or mobile center. Each patient may be entered into the study only once. Subject enrollment and/or Day 1 blood draw is not associated with a specific time point in the ovulatory cycle.
Who may be able to join
- Females, age ≥ 21 years
- Premenopausal (defined as a woman that has had at least one menstrual cycle in the last 365 days).
- A minimum weight of 110 lbs
- The subject is not anemic (Hemoglobin ≥ 12.5 g/dL)
- Willing to provide a daily blood draw for one ovulatory cycle or a maximum of 33 days
- Able to understand and willing to provide informed consent.
Who cannot join
- Males
- Females, age <21 years
- Weighing < 110 lbs
- Anemic (Hemoglobin < 12.5 g/dL)
- History of bilateral oophorectomy
- Females taking any form of hormonal birth control including:
Show all 25Show fewer
- Oral contraceptive pill (combined or progestin-only) within five days enrollment.
- Contraceptive patch (such as Ortho Evra®) within seven days of enrollment.
- Vaginal contraceptive ring (such as NuvaRing™) within 21 days of enrollment.
- Contraceptive injection (such as Depo-Provera®) within 90 days of enrollment.
- Intra-uterine system (IUS) within 90 days of enrollment. An intra-uterine device (IUD) made of copper does not exclude the patient from participating in this study.
- Subdermal contraceptive implants (such as Nexplanon®) within 90 days of enrollment.
- Emergency contraceptive within 30 days of enrollment.
- Women in menopause (defined as the end of menstrual cycles or at least more than 365 days since the last menstrual cycle)
- Amenorrhea except for women that continue to ovulate as documented in a physician note available to the enrolling center.
- Has a current diagnosis of any clinically significant cardiac, respiratory, neurological, immunological, hematological, liver disease, renal disease, gastrointestinal (GI) disorder, including any history of hyper- or hypothyroid, peptic or gastric ulcers or GI bleeding, or any other condition which, in the opinion of the investigator, would deem the subject unhealthy and therefore, ineligible.
- Has a history of any clinically significant cardiac, respiratory, neurological, immunological, hematological, liver disease, renal disease, gastrointestinal (GI) disorder, including any history of hyper- or hypothyroid, peptic or gastric ulcers or GI bleeding, or any other condition which, in the opinion of the investigator, is unstable at the time of enrollment.
- Is receiving systemic chemotherapy or radiation treatment, has an active malignancy of any type, or has been diagnosed with cancer within 5 years before screening other than basal or squamous cell skin cancers or in-situ cervical cancer.
- History of seizures
- Diagnosed with an infectious disease including any sexually transmitted diseases.
- Diagnosed with HIV/AIDS or ever tested positive for HIV.
- History of hepatitis
- Subject that has had sexual contact with a person who has hepatitis within the last 12 months.
- Pregnancy, lactation or actively seeking to conceive (trying to become pregnant).
- Unable to provide informed consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Vita Pharma
Hialeah, Florida, 33016
American Blood Bank, Inc.
Miami, Florida, 33193
About this study
Official title: A Prospective Collection of Peripheral Blood Specimens to Study Fertility in Healthy, Premenopausal Women
The study objectives are described below:
- Obtain serum specimens collected for one ovulatory cycle or a maximum of 33 days, but not to exceed a total of 550 ml of whole blood per subject from a minimum of 60 healthy, premenopausal subjects. Specimens will be used to determine a reference range for estradiol, FSH, LH, and progesterone assays, used as an aid in the assessment of fertility in adult, premenopausal women.
- To store any remaining specimens for use in future assay development and to evaluate as yet undetermined assays for the development of IVDs, including additional estradiol, FSH, LH, and progesterone assays.
Read the detailed description
The purpose of this study is to obtain sufficient specimens and correlating clinical data from a well-controlled prospective clinical trial collecting specimens from healthy, premenopausal subjects to support domestic and international regulatory submissions on fertility biomarker assays, and to establish a collection of specimens that will support future assay discovery and validation efforts.
- Conditions
- Fertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of fertility hormone levels in 60 + healthy premenopausal women
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujirebio Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diana Dickson, Study director, Fujirebio Diagnostics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772848
- Sponsor's protocol ID
- FDI-81
- Status last verified
- Apr 2016
- First submitted
- 19 Apr 2016
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Collection of Peripheral Blood Specimens to Study Fertility in Healthy, Premenopausal Women
- ClinicalTrials.gov ID
- NCT02772848
- Acronym / sponsor ID
- FDI-81
- Conditions
- Fertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fujirebio Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objectives are described below:
- Obtain serum specimens collected for one ovulatory cycle or a maximum of 33 days, but not to exceed a total of 550 ml of whole blood per subject from a minimum of 60 healthy, premenopausal subjects. Specimens will be used to determine a reference range for estradiol, FSH, LH, and progesterone assays, used as an aid in the assessment of fertility in adult, premenopausal women.
- To store any remaining specimens for use in future assay development and to evaluate as yet undetermined assays for the development of IVDs, including additional estradiol, FSH, LH, and progesterone assays.
Detailed description
The purpose of this study is to obtain sufficient specimens and correlating clinical data from a well-controlled prospective clinical trial collecting specimens from healthy, premenopausal subjects to support domestic and international regulatory submissions on fertility biomarker assays, and to establish a collection of specimens that will support future assay discovery and validation efforts.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A minimum of 60 subjects will be enrolled in this study. Healthy, premenopausal women greater than or equal to 21 years of age having donated a serial blood collection throughout a single ovulation cycle or a maximum of 33 days will be eligible. Each site or mobile center will evaluate and select patients for enrollment using the inclusion and exclusion criteria listed below. Study subjects should be selected from all available patients at the site or mobile center. Each patient may be entered into the study only once. Subject enrollment and/or Day 1 blood draw is not associated with a specific time point in the ovulatory cycle.
Key inclusion criteria (6 listed)
- Females, age ≥ 21 years
- Premenopausal (defined as a woman that has had at least one menstrual cycle in the last 365 days).
- A minimum weight of 110 lbs
- The subject is not anemic (Hemoglobin ≥ 12.5 g/dL)
- Willing to provide a daily blood draw for one ovulatory cycle or a maximum of 33 days
Key exclusion criteria (25 listed)
- Males
- Females, age <21 years
- Weighing < 110 lbs
- Anemic (Hemoglobin < 12.5 g/dL)
- History of bilateral oophorectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of fertility hormone levels in 60 + healthy premenopausal women
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Dickson study director
Fujirebio Diagnostics, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility, run by Fujirebio Diagnostics, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of fertility hormone levels in 60 + healthy premenopausal women (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2016; AzTrials last refreshed its copy on 7 Nov 2026.