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Active, not recruitingNCT01421095Updated Jun 10, 2024

Ovarian Reserve Testing in Female Young Adult Cancer Survivors

An interventional study of recombinant FSH in Cancer and Infertility, sponsored by University of California, San Diego. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-06-10.

Sponsored by University of California, San Diego · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
18 Years to 35 Years
Sex
Female
01

Study summary

Young adult cancer survivors constitute an under served population to whom fertility potential is particularly important. For female young adult patients, cancer treatment such as alkylating chemotherapy are toxic to the finite number of eggs they have, resulting in risks of infertility and premature menopause related to ovarian failure. Reproductive issues are a major concern for young cancer survivors, but one that is understudied. Young cancer survivors have few tools to measure post-treatment ovarian reserve, or the quantity and quality of remaining eggs4. Accurate determination of ovarian reserve and fertility potential would not only be an important research tool, but also directly impact clinical management. The purpose of this study is to test if basal and provocative ovarian reserve testing can predict return of menses in female young adult cancer survivors, to compare basal and provocative ovarian reserve testing results between female young adult cancer survivors and healthy controls, and to compare basal and provocative ovarian reserve testing results between female young adult cancer survivors on and off of combined estrogen and progesterone hormone products.

Participants will be asked to keep track of their periods over three months. If a participant is taking birth control pills, patches, or vaginal ring, they will asked to come off the birth control for 3 months. Participants will also be asked to undergo ovarian reserve testing by blood draws and pelvic ultrasounds at the start and end of the 3 months.

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Same as brief summary

02

Conditions studied

  • Cancer
  • Infertility

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Keywords

  • Fertility
  • adolescent
  • young adult
  • cancer survivors
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 34 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

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Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Postmenarchal
  • Cancer diagnosis
  • Prior exposure to gonadotoxic therapy, inclusive of chemothearpy, pelvic or total body irradiation, unilateral oophorectomy
  • A minimum of 1 year since completion of gonoadotoxic therapy
  • Intact uterus
  • At least one ovary

Exclusion criteria

Exclusion Criteria:

  • Estrogen receptor positive cancers
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (estimated)

Study arms

  • Experimental
    Basal Testing

    Drug: recombinant FSH

Interventions

  • Drugrecombinant FSH

    Each participant will recieve recombinant FSH (150 IU) intravenously

    Also known as: Gonal F

06

What researchers measure

Primary outcomes

  1. Return of menses

    Self reported via bleeding calenders

    Time frame: 3 months

Secondary outcomes

  1. Blood levels of FSH

    Time frame: 3 months

  2. Blood levels of estradiol

    Time frame: 3 months

  3. Blood levels of AMH

    Time frame: 3 months

  4. Blood levels of inhibin B

    Time frame: 3 months

07

Study locations

1 site
  • UCSD Moores Cancer Center
    San Diego, California 91351, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01421095
Lead sponsor
University of California, San Diego
Responsible party
Hui-Chun Irene Su (Assistant Professor of Reproductive Medicine, University of California, San Diego) — Principal investigator
First posted
Aug 22, 2011
Start date
Jan 1, 2011
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jun 10, 2024

Study contacts

H. Irene Su, MD MSCE
principal investigator · UC San Diego

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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