Ovarian Reserve After Cancer: Longitudinal Effects

NCT02467231 | Active Not Recruiting

• 1 other identifier: 809406
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

Women of reproductive age who will receive treatment for cancer that includes chemotherapy may participate in a study measuring ovarian function over time. Eligible women are asked to complete a questionnaire, a menstrual diary, a brief physical examination, an ultrasound, and a blood test before, during and after cancer treatment.

Conditions

Effects of Chemotherapy; Premature Ovarian Failure

Keywords

new diagnosis of cancer; chemotherapy; oncofertility; alkylating agent; fertility preservation; fertility after cancer; late effects

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.

  18-30 months: pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy.

Secondary Outcomes (1)

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

  18-30 months: pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy.

Other Outcomes (3)

• Change from baseline in menstrual function, during and after chemotherapy

  18-30 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 during and after chemotherapy.

  18-30 months: Pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy.

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

  18-30 months: Pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy.

Study Arms (1)

Exposed

Females ages 11-35 to be exposed to alkylating agent chemotherapy

Eligibility Criteria

• Age: 11 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Postmenarchal females, ages 11-35, who will require chemotherapy; An unexposed cohort balanced to the exposed cohort with respect to age and oral contraceptive use.

You may qualify if:

• Postmenarchal females to be treated with chemotherapy
• between the ages of 11-35 years,
• with a uterus and at least one ovary
• healthy postmenarchal females
• no prior or planned exposure to chemotherapy
• between the ages of 11-35,
• with a uterus and at least one ovary
• regular menstrual cycles (21-35 days)

You may not qualify if:

• positive pregnancy test at enrollment
• lactation within the previous 1 month,
• previous treatment with chemotherapy or radiation therapy with the exception of radioactive iodine for thyroid cancer.
• previous diagnosis of an illness associated with premature ovarian failure (Turner's syndrome, Fragile X permutation carrier)
• endocrine disorder associated with irregular menstrual cycles (Cushing's disease, Thyroid disease, hyper-prolactinemia, congenital adrenal hyperplasia).
• a history of infertility, defined as at least 12 months of unprotected intercourse without conception
• polycystic ovary syndrome (PCOS)

Sponsors & Collaborators

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

Study Sites (1)

University of Pennsylvania, Reproductive Research Unit

Philadelphia, Pennsylvania, 19104-5509, United States

Location

Related Publications (2)

• Dillon KE, Sammel MD, Prewitt M, Ginsberg JP, Walker D, Mersereau JE, Gosiengfiao Y, Gracia CR. Pretreatment antimullerian hormone levels determine rate of posttherapy ovarian reserve recovery: acute changes in ovarian reserve during and after chemotherapy. Fertil Steril. 2013 Feb;99(2):477-83. doi: 10.1016/j.fertnstert.2012.09.039. Epub 2012 Oct 18.

  PMID: 23084267 BACKGROUND

• Cameron K, Sammel MD, Prewitt M, Gracia C. Differential Rates of Change in Measures of Ovarian Reserve in Young Cancer Survivors Across the Reproductive Lifespan. J Clin Endocrinol Metab. 2019 May 1;104(5):1813-1822. doi: 10.1210/jc.2018-02257.

  PMID: 30566616 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System 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: July 22, 2013
• First Posted: June 9, 2015
• Study Start: February 1, 2009
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 28, 2025

Record last verified: 2025-10

Locations

US (1)