Fertility in Healthy Premenopausal Women

NCT02772848 | Completed

• 1 other identifier: FDI-81
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The study objectives are described below:

1. 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. 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.
2. 2.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.

Conditions

Fertility

Outcome Measures

Primary Outcomes (1)

• Measurement of fertility hormone levels in 60 + healthy premenopausal women

  3 months

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Fujirebio Diagnostics, Inc.: lead

Study Sites (2)

Vita Pharma

Hialeah, Florida, 33016, United States

Location

American Blood Bank, Inc.

Miami, Florida, 33193, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

Study Officials

• Diana Dickson

  Fujirebio Diagnostics, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: May 16, 2016
• Study Start: April 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 10, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)