InfertilityNCT01403688
Effects of Controlled Ovarian Hyperstimulation (COH) With Letrozole and Gonadotropin
An observational study of Infertility and Breast Cancer, run by University of Kansas at 1 site in United States.
Trial summary
Fertility drugs have the effect of increasing hormone levels. Higher hormone levels from infertility treatments may increase breast cancer risk, but there has not been enough research to know for sure. Researchers want to use a method of taking breast tissue cells from women who are having infertility treatment. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Breast Cancer
- What is being tested?
- RPFNA
- Type of treatment
- Surgery or procedure
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Infertility Patients undergoing COH treatment and at high risk for breast cancer
Who may be able to join
- Women must be at increased risk for breast cancer based on any of the following criteria:
- Age 30 or older with no prior live birth.
- Mutations associated with hereditary cancer (BRCA1 or 2, P53, PTEN)
- Family history of breast cancer including one first degree or multiple second degree relatives
- History of chest radiation before age 30
- Multiple prior breast biopsies
Show all 11Show fewer
- Precancerous conditions (DCIS, LCIS, AH)
- Prior history of breast or ovarian cancer
- Estimated mammographic breast density > 50%
- Must be undergoing infertility treatment at the University of Kansas with Controlled Ovarian Hyper-stimulation (COH)
- Must be between the ages of 21-45 (both inclusive) with Day 3 FSH less than 12 IU/L, Day 3 E2 less than 80 pg/ml
Who cannot join
- Women under 21 or over 45 years old
- Day 3 FSH over 12 IU/L, Day 3 E2 over 80 pg/ml
- Women who do not meet risk criteria above
- History of hypersensitivity to letrozole or gonadotropin
- Uterine and adnexal pathology
- Use of clomid or gonadotropin within 30days before the letrozole cycle
- Any severe chronic disease of relevance for reproductive function
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Effects of Controlled Ovarian Hyperstimulation (COH) With Letrozole and Gonadotropin in Women at High Risk for Breast Cancer
Fertility drugs have the effect of increasing hormone levels. Higher hormone levels from infertility treatments may increase breast cancer risk, but there has not been enough research to know for sure. Researchers want to use a method of taking breast tissue cells from women who are having infertility treatment. The breast tissue cells might show changes that would indicate an increased risk of cancer. The method of taking the breast tissue cells is called Fine Needle Aspiration (FNA).
The purpose of this study is to examine the changes in breast tissue, in women at high risk of breast cancer who are being treated with controlled ovarian hyperstimulation.
- Conditions
- Infertility, Breast Cancer
- Being tested
- RPFNA
- Keywords
- fertility high risk, controlled ovarian stimulation, breast cancer
- Medical subject headings
- Infertility, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPFNAProcedure or surgery
- Baseline RPFNA within 3 month prior to the initial COH cycle or within the first 10 days of the treatment cycle (delete this).
- Repeat RPFNA if pregnancy is not achieved: 6 to 18 months following baseline assessment
- Repeat RPFNA if pregnancy is achieved: approximately 12 months after discontinuation of breast feeding
| Study group | Role | What they receive |
|---|---|---|
| Random Fine Needle Aspiration (RPFNA) | RPFNA Receives: Procedure: RPFNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation with pre- and post-treatment(COH) breast cytomorphometry and biomarkers
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Kim, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403688
- Sponsor's protocol ID
- 11357
- Status last verified
- Sep 2014
- First submitted
- 14 Jul 2011
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Controlled Ovarian Hyperstimulation (COH) With Letrozole and Gonadotropin in Women at High Risk for Breast Cancer
- ClinicalTrials.gov ID
- NCT01403688
- Acronym / sponsor ID
- 11357
- Conditions
- Infertility, Breast Cancer
- Keywords
- fertility high risk, controlled ovarian stimulation, breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 27 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fertility drugs have the effect of increasing hormone levels. Higher hormone levels from infertility treatments may increase breast cancer risk, but there has not been enough research to know for sure. Researchers want to use a method of taking breast tissue cells from women who are having infertility treatment. The breast tissue cells might show changes that would indicate an increased risk of cancer. The method of taking the breast tissue cells is called Fine Needle Aspiration (FNA).
The purpose of this study is to examine the changes in breast tissue, in women at high risk of breast cancer who are being treated with controlled ovarian hyperstimulation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Random Fine Needle Aspiration (RPFNA) | – | Procedure: RPFNARPFNA |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Infertility Patients undergoing COH treatment and at high risk for breast cancer
Key inclusion criteria (11 listed)
- Women must be at increased risk for breast cancer based on any of the following criteria:
- Must be undergoing infertility treatment at the University of Kansas with Controlled Ovarian Hyper-stimulation (COH)
- Must be between the ages of 21-45 (both inclusive) with Day 3 FSH less than 12 IU/L, Day 3 E2 less than 80 pg/ml
Key exclusion criteria (7 listed)
- Women under 21 or over 45 years old
- Day 3 FSH over 12 IU/L, Day 3 E2 over 80 pg/ml
- Women who do not meet risk criteria above
- History of hypersensitivity to letrozole or gonadotropin
- Uterine and adnexal pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RPFNA1. Baseline RPFNA within 3 month prior to the initial COH cycle or within the first 10 days of the treatment cycle (delete this). 2. Repeat RPFNA if pregnancy is not achieved: 6 to 18 months following baseline assessment 3. Repeat RPFNA if pregnancy is achieved: approximately 12 months after discontinuation of breast feeding | Procedure or surgery | Random Fine Needle Aspiration (RPFNA) |
Primary outcome
evaluation with pre- and post-treatment(COH) breast cytomorphometry and biomarkers
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Kim, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Breast Cancer, run by University of Kansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation with pre- and post-treatment(COH) breast cytomorphometry and biomarkers (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2014.