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Assessing Fertility Potential in Female Cancer Survivors


N/A
15 Years
50 Years
Open (Enrolling)
Female
History of Cancer

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Trial Information

Assessing Fertility Potential in Female Cancer Survivors


A total of 291 females will participate in this study: 3 groups with 97 women in each group.

- Cancer survivors, ages 15-40, who have been exposed to alkylating agent chemotherapy
and/or radiation therapy

- Unexposed peers, ages 15-40, never exposed to chemotherapy or radiation therapy

- Late Reproductive Aged volunteers, ages 41-50 never exposed to chemotherapy or
radiation therapy

Inclusion Criteria


Inclusion Criteria for cancer survivors:

- Previous treatment with chemotherapy and/or radiation therapy for either cancer
or another illness.

- Age between 15-40 years.

- Post-menarchal.

- Presence of a uterus and at least one ovary.

- Ability and willingness to comply with stuy protocol.

- Have given written informed consent, prior to any study-related procedure, not part
of normal medical care, with the understanding that consent may be withdrawn by the
patient at any time without prejudice to their future medical care.

Inclusion Criteria for controls:

- Healthy females who have never been treated for cancer.

- Age between 15 and 50 years.

- Post-menarchal with regular cyclic menses (every 21-35 days)

- Presence of a uterus and at least 1 ovary.

- Ability and willingness to comply with study protocol.

- Have given written informed concent, prior to any study-related procedure, not part
of normal medical care, with the understanding that consent may be withdrawn by the
patient at any time without prejudice to their future medical care.

Exclusion Criteria:

- Current pregnancy.

- Use of hormonal contraception or use of hormone replacement therapy within the
previous 4 weeks.

- Lactation within the previous 3 months.

- Chronic illness that would limit ability of participant to comply with study
protocol.

- Any known medical condition, other than cancer, which in the judgement 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).

- For controls, a history of infertility.

Additional inclusion criteria for clomiphene citrate sub-study:

- Age between 18 and 42 years.

Additional exclusion criteria for the clomiphene citrate sub-study:

- Known allergy or hypersensitivity to clomiphene citrate.

- History of liver dysfunction.

- Abnormal uterine bleeding.

- Ovarian cysts

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Authority:

United States: Institutional Review Board

Study ID:

804237

NCT ID:

NCT01143844

Start Date:

March 2006

Completion Date:

July 2015

Related Keywords:

  • History of Cancer
  • Oncofertility
  • Fertility
  • Late effects
  • cancer
  • chemotherapy
  • radiation therapy
  • survivor
  • ovarian reserve
  • premature ovarian failure
  • early menopause
  • healthy volunteers
  • perimenopause
  • middle age
  • pediatric survivors

Name

Location

Penn Reproductive Research Unit, 3701 Market Street, Suite 810Philadelphia, Pennsylvania  19104
Penn Medicine at Radnor, 250 King of Prussia RoadRadnor, Pennsylvania  19087