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NCT01143844 · ClinicalTrials.gov registry record

Assessing Fertility Potential in Female Cancer Survivors

A clinical trial of Effects of Chemotherapy, sponsored by University of Pennsylvania.

Completed
Registry status
391
Enrollment target
2
Study locations

NCT01143844: Completed study of Effects of Chemotherapy, sponsored by University of Pennsylvania.

NCT01143844 is a study of Effects of Chemotherapy that has completed, run by University of Pennsylvania. The registered enrollment target is 391 participants. The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01143844, a study of Effects of Chemotherapy, has completed, sponsored by University of Pennsylvania.

COMPLETED
Registry status
391 participants
Enrollment target
2
Study locations

Study Summary

Hypothesis: Girls and women exposed to chemotherapy and/or radiation therapy experience endocrine changes more similar to women in their late reproductive years than to same-age peers. These changes will be more dramatic in women who receive high dose therapy compared to women who receive low dose therapy. At annual visits over 3-5 years, a combination of physical exam, medical history, menstrual diary keeping, pelvic ultrasound and blood hormones tests will be used to measure "ovarian reserve" , that is the number and quality of the eggs that remain in the ovaries. The study will also try to learn if those who received higher doses of certain chemotherapies are more likely to have changes in these tests sooner than those women who received smaller doses of these same drugs. Additionally a DNA (deoxyribonucleic acid) sample will be collected to look for gene variations that may predict susceptibility to ovarian damage from cancer treatments. Information learned from this study may help researchers to develop guidelines to identify problems with a female cancer survivor's ovaries before irregular menses or other symptoms of ovarian failure occur.

Primary Outcome

Primary Outcomes for this study will include mean and changes in reproductive hormone measures obtained during the early follicular phase of the menstrual cycle (days 1-4).

Conditions Studied

Study Locations (2)

Pennsylvania

  • Penn Reproductive Research Unit, 3701 Market Street, Suite 810 - Philadelphia
  • Penn Medicine at Radnor, 250 King of Prussia Road - Radnor

Trial Details

FieldValue
Enrollment Target 391 participants
Start Date 2006-03
Est. Completion 2020-03-30
University of Pennsylvania

1,423 total trials

What the finished NCT01143844 record still lists

NCT01143844 is an observational study that tracks outcomes without assigning an intervention. The registered 391 participants enrollment target is mid-sized for trials with a published cap.

The record links to 1 condition, with Effects of Chemotherapy appearing as the primary indexed condition, and to 0 interventions.

NCT01143844 reports a single indexed study location in Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT01143844 about?

NCT01143844 is a clinical study titled "Assessing Fertility Potential in Female Cancer Survivors". Hypothesis: Girls and women exposed to chemotherapy and/or radiation therapy experience endocrine changes more similar to women in their late reproductive years than to same-age peers. These changes will be more dramatic in women who receive high dose therapy compared to women who receive low dose t...

What is the current status of trial NCT01143844?

This trial is currently completed. The enrollment target is 391 participants. The study started on 2006-03. Estimated completion is 2020-03-30.

What conditions does trial NCT01143844 study?

This clinical trial studies the following conditions: Effects of Chemotherapy.

Who is sponsoring clinical trial NCT01143844?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01143844 being conducted?

This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT01143844, the US trial registry maintained by the National Library of Medicine. NCT01143844 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.