The Longitudinal Ovarian Reserve Study

NCT02395341 | Completed DMC

• 1 other identifier: 806409
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Postmenarchal female cancer patients scheduled to undergo cancer therapy may enroll in this study to assess changes in existing and novel surrogate measures of fertility potential before, during and after chemotherapy. Measures of fertility potential to be tested include ultrasound imaging for antral follicle counts and ovarian volumes, endocrine evaluation, and assessment of oxidative stress.

Conditions

Effects of Chemotherapy

Keywords

reproductive hormones; cancer survivors; endocrine function; antral follicle counts; female infertility due to diminished ovarian reserve; perimenopause; premature menopause

Outcome Measures

Primary Outcomes (1)

• Change from baseline in reproductive hormone measures, during and after chemotherapy.

  20 mls blood will be obtained at stated timepoints for determining levels of Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol (E2), Inhibin B, and Anti-mullerian Hormone (AMH). In menstruating girls and young women hormone measures will be obtained during the early follicular phase of the menstrual cycle (days 1-4). In women with irregular cycles the testing will be done spontaneously without regard for the bleeding pattern.

  18-24 months: pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy.

Secondary Outcomes (6)

• Change from baseline in ovarian volume during and after chemotherapy.

  18-24 months: Pelvic ultrasound will be performed at Pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy.

• Change from baseline in antral follicle counts during and after chemotherapy.

  18-24 months: Pelvic ultrasound will be performed at Pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy.

• Change in urinary isoprostane levels from baseline to 6 months after end of chemotherapy

  18-24 months: 24 hour urine collection will be performed at Pre-chemotherapy baseline and at the final study visit.

• Change from baseline in menstrual characteristics

  18-24 months: Pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy.

• Change from baseline in menopausal symptoms

  18-24 months: Pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy.

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be referred for this study by their primary oncologists. Eligible reproductive-aged girls and women newly diagnosed with cancer or another condition requiring chemotherapeutic intervention will be enrolled

You may qualify if:

• Females with the diagnosis of cancer schedules to be treated with chemotherapy and or radiation therapy.
• Age between 15-45 years.
• Post-menarchal.
• Presence of a uterus and both ovaries.
• Ability and willingness to comply with study protocol.
• Have given written informed concent (or assent with parental consent in minors), prior to any study-related procedure, not part of normal medical care, with the understanding that consent may be withdrawn byt he patient at any time without prejudice to their future medical care.

You may not qualify if:

• Current pregnancy.
• Lactation within the previous 3 months.
• Any medical condition other than cancer, with in the judgment of the investigator is known to be associated with premature ovarian failure (such as Turner's Syndrome or Fragile X) or ovulatory dysfunction (such as thyroid disease, adrenal dysfunction, Cushing's syndrome, hyperprolactinemia, and polycystic ovarian syndrome).

Sponsors & Collaborators

• University of Pennsylvania: lead
• Children's Hospital of Philadelphia: collaborator

Study Sites (2)

Penn Reproductive Research Unit, 3701 Market Street, Suite 810

Philadelphia, Pennsylvania, 19104, United States

Location

Penn Medicine at Radnor, 250 King of Prussia Road

Radnor, Pennsylvania, 19087, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Menopause, Premature

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Clarisa R Gracia, MD, MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: March 23, 2015
• Study Start: May 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: April 1, 2013
• Last Updated: August 22, 2016

Record last verified: 2016-08

Locations

US (2)