Ovarian Damage in Young Premenopausal Women Undergoing Chemotherapy for Cancer

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 14 to 35 years
• Women only
• No healthy volunteers
• Child, Adult

Study population: premenopausal women undergoing chemotherapy for cancer

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Effects of Cytotoxic Chemotherapy on Ovarian Structure and Function

Conditions

Leukemia, Long-term Effects Secondary to Cancer Therapy in Adults, Long-term Effects Secondary to Cancer Therapy in Children, Lymphoma, Sexual Dysfunction and Infertility, Sexuality and Reproductive Issues

Being tested

laboratory biomarker analysis, fertility assessment and management, management of therapy complications, ultrasound imaging

Keywords

long-term effects secondary to cancer therapy in adults, long-term effects secondary to cancer therapy in children, sexual dysfunction and infertility, sexuality and reproductive issues, adult acute lymphoblastic leukemia in remission, childhood acute lymphoblastic leukemia in remission, recurrent adult acute lymphoblastic leukemia, recurrent childhood acute lymphoblastic leukemia, untreated adult acute lymphoblastic leukemia, untreated childhood acute lymphoblastic leukemia, adult acute myeloid leukemia in remission, recurrent adult acute myeloid leukemia, recurrent childhood acute myeloid leukemia, untreated adult acute myeloid leukemia, untreated childhood acute myeloid leukemia and other myeloid malignancies, secondary acute myeloid leukemia, stage I adult Hodgkin lymphoma, stage I childhood Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage II childhood Hodgkin lymphoma

Medical subject headings

Leukemia, Lymphoma, Sexual Dysfunction, Physiological, Infertility, Sexuality, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• laboratory biomarker analysisOther

  Patients undergo blood collection at the same time points for follicle-stimulating hormone, estradiol, and inhibin B levels.

• fertility assessment and managementProcedure or surgery

  Patients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles.

• management of therapy complicationsProcedure or surgery

  Patients are also asked to fill out questionnaires on estrogen-depletion symptoms at those times. Patients also keep a calendar of menstrual bleeding and hormonal medications.

• ultrasound imagingProcedure or surgery

  Patients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Incidence of ovarian damage after cytotoxic chemotherapy as determined by changes in ovarian volume, antral follicle count, and follicle-stimulating hormone, estradiol, and inhibin B levels

   Measured: Ultrasound to measure the ovarian volume and count the number of antral follicles at baseline, 3 months after beginning cytotoxic chemotherapy, and at 6 months after completion of treatment. Patients undergo blood collection at the same time points.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted23 Nov 2006 (estimated)
2. Study startFeb 2004
3. Study completionMay 2007

Why it stopped: slow accrual

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for LeukemiaStudies 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.