Ovarian CancerNCT00342446
A Follow-up Study of Women Evaluated and Treated for Infertility
An observational study of Ovarian Cancer and Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
To assess the relations of infertility causes and treatment to cancer risk, we will conduct a retrospective cohort study of approximately 12,000 women evaluated for infertility between 1965-1988. Read more about this study
- Who is it for?
- Ages 44 to 88 years, women only
- Conditions the study is for
- Ovarian Cancer, Breast Cancer, Endometrial Cancer
- How many people
- 12,193 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 1995to 11 Jan 2023
- 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 44 to 88 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Subjects were enrolled based on treatment at fertility clinic.@@@
Who may be able to join
- The following criteria for inclusion in the study cohort will apply:
- Patient is female.
- Patient was evaluated for infertility between (and including) 1965 and 1988.
- Patient had a U.S. address at the time of evaluation for infertility.
- Patient was seen twice by the physician, or was seen once but had a referral from another physician.
- Patient's infertility was not due to gonadal dysgenesis or congenital abnormalities of the reproductive system.
- Patient's visit to the infertility specialist was not to have a tubal ligation reversed.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow-Up Study of Women Evaluated and Treated for Infertility
To assess the relations of infertility causes and treatment to cancer risk, we will conduct a retrospective cohort study of approximately 12,000 women evaluated for infertility between 1965-1988. These women will be ascertained from several large infertility clinics and private practices in various geographic locations in the United States: Boston, Chicago, Detroit, New York, and Palo Alto. These practices were selected on the basis of their having large number of patients who received ovulation stimulating drugs many years in the distant past. Abstractors reviewed clinic medical records to identify eligible study participants and abstract data needed to classify causes of infertility and document therapies employed. Using a variety of tracing sources (including the National Death Index, credit bureaus, and postmasters), the vital status and location of the study subjects were determined. Subjects who were traced and identified as alive are being sent a detailed questionnaire that requests information on their health status as well as on a number of lifestyle practices. For subjects who report a cancer, medical verification is being sought from the diagnosing physicians and/or facilities. Death certificates are being sought for deceased subjects.
Read the detailed description
BACKGROUND: We previously conducted a retrospective cohort study of 12,193 patients evaluated for infertility between 1960-1988 at five clinical sites. Detailed information abstracted from the medical records, along with questionnaires administered to located patients and cancer incidence and mortality data derived from cancer registries and the National Death Index, allowed us to examine cancer risk related to different causes of infertility and treatments while controlling for other patient characteristics. Although there were some increases of certain cancers related to various causes of infertility, we generally did not observe substantial relationships related to use of different fertility drugs. The one exception was some increased risk of uterine cancers with clomiphene use, of interest given the drug's chemical similarity to tamoxifen. Our numbers of patients with certain cancers (e.g., ovarian, uterine) were, however, limited and we had insufficient power to evaluate subgroup effects (e.g., drug relationships among nulligravid women).
OBJECTIVES: We therefore conducted an updated follow-up of these patients in order to assess cancer risk in relation to causes of infertility and therapeutic regimens used to treat these causes.
ELIGIBILITY: This study gained an additional 10 years of follow-up among the patients deemed eligible for the previous investigation. This included women with both primary and second infertility. Approximately 39% of the cohort previously were prescribed clomiphene citrate, while 10% received gonadotrophins.
DESIGN: Passive follow-up was attempted for patients who previously did not participate and for whom only information available in clinic records could be retained. All other patients were traced for active as well as passive follow-up. Active follow-up involved requesting that patients complete a short questionnaire, whereas passive follow-up was via linkage to cancer registries and the National Death Index. While cancer risks were assessed in relation to the general population, the majority of comparisons were internal ones, involving the calculation of relative risks (RRs) associated with different causes of infertility or treatment regimens while controlling for other cancer risk predictors.
- Conditions
- Ovarian Cancer, Breast Cancer, Endometrial Cancer, Thyroid Cancer, Colorectal Cancer, Melanoma
- Keywords
- Gonadotropins, CLOMIPHENE, Ovulation-Stimulating Drugs, Natural History
- Medical subject headings
- Ovarian Neoplasms, Breast Neoplasms, Endometrial Neoplasms, Thyroid Neoplasms, Colorectal Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Infertility | Patients of all races with primary or secondary infertility, including women with recurrent miscarriages. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer
Breast, endometrial, ovarian, thyroid, melanoma
Measured: ongoing
Secondary outcomes (1)
Mortality
All cause and cancer-specific death
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start1 Oct 1995
- Primary completion31 Dec 2012
- Study completion11 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12,193 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Gretchen Benson, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00342446
- Sponsor's protocol ID
- 999996019
- Other IDs
- OH96-C-N019
- Status last verified
- Jan 2024
- First submitted
- 19 Jun 2006
- Last updated
- 11 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bamford PN, Steele SJ. Uterine and ovarian carcinoma in a patient receiving gonadotrophin therapy. Case report. Br J Obstet Gynaecol. 1982 Nov;89(11):962-4. doi: 10.1111/j.1471-0528.1982.tb05067.x. No abstract available.
PubMed 7171506Carter ME, Joyce DN. Ovarian carcinoma in a patient hyperstimulated by gonadotropin therapy for in vitro fertilization: a case report. J In Vitro Fert Embryo Transf. 1987 Apr;4(2):126-8. doi: 10.1007/BF01555453. No abstract available.
PubMed 3110335Atlas M, Menczer J. Massive hyperstimulation and borderline carcinoma of the ovary. A possible association. Acta Obstet Gynecol Scand. 1982;61(3):261-3. doi: 10.3109/00016348209156568.
PubMed 7124357
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-Up Study of Women Evaluated and Treated for Infertility
- ClinicalTrials.gov ID
- NCT00342446
- Acronym / sponsor ID
- 999996019
- Conditions
- Ovarian Cancer, Breast Cancer, Endometrial Cancer, Thyroid Cancer, Colorectal Cancer, Melanoma
- Keywords
- Gonadotropins, CLOMIPHENE, Ovulation-Stimulating Drugs, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,193 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 1 Oct 1995 (actual)
- Primary completion
- 31 Dec 2012 (actual)
- Study completion
- 11 Jan 2023 (actual)
- First posted
- 21 Jun 2006 (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.
To assess the relations of infertility causes and treatment to cancer risk, we will conduct a retrospective cohort study of approximately 12,000 women evaluated for infertility between 1965-1988. These women will be ascertained from several large infertility clinics and private practices in various geographic locations in the United States: Boston, Chicago, Detroit, New York, and Palo Alto. These practices were selected on the basis of their having large number of patients who received ovulation stimulating drugs many years in the distant past. Abstractors reviewed clinic medical records to identify eligible study participants and abstract data needed to classify causes of infertility and document therapies employed. Using a variety of tracing sources (including the National Death Index, credit bureaus, and postmasters), the vital status and location of the study subjects were determined. Subjects who were traced and identified as alive are being sent a detailed questionnaire that requests information on their health status as well as on a number of lifestyle practices. For subjects who report a cancer, medical verification is being sought from the diagnosing physicians and/or facilities. Death certificates are being sought for deceased subjects.
Detailed description
BACKGROUND: We previously conducted a retrospective cohort study of 12,193 patients evaluated for infertility between 1960-1988 at five clinical sites. Detailed information abstracted from the medical records, along with questionnaires administered to located patients and cancer incidence and mortality data derived from cancer registries and the National Death Index, allowed us to examine cancer risk related to different causes of infertility and treatments while controlling for other patient characteristics. Although there were some increases of certain cancers related to various causes of infertility, we generally did not observe substantial relationships related to use of different fertility drugs. The one exception was some increased risk of uterine cancers with clomiphene use, of interest given the drug's chemical similarity to tamoxifen. Our numbers of patients with certain cancers (e.g., ovarian, uterine) were, however, limited and we had insufficient power to evaluate subgroup effects (e.g., drug relationships among nulligravid women).
OBJECTIVES: We therefore conducted an updated follow-up of these patients in order to assess cancer risk in relation to causes of infertility and therapeutic regimens used to treat these causes.
ELIGIBILITY: This study gained an additional 10 years of follow-up among the patients deemed eligible for the previous investigation. This included women with both primary and second infertility. Approximately 39% of the cohort previously were prescribed clomiphene citrate, while 10% received gonadotrophins.
DESIGN: Passive follow-up was attempted for patients who previously did not participate and for whom only information available in clinic records could be retained. All other patients were traced for active as well as passive follow-up. Active follow-up involved requesting that patients complete a short questionnaire, whereas passive follow-up was via linkage to cancer registries and the National Death Index. While cancer risks were assessed in relation to the general population, the majority of comparisons were internal ones, involving the calculation of relative risks (RRs) associated with different causes of infertility or treatment regimens while controlling for other cancer risk predictors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Infertility | – | –Patients of all races with primary or secondary infertility, including women with recurrent miscarriages. |
Who may qualify
- Ages
- 44 to 88 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects were enrolled based on treatment at fertility clinic.@@@
Key inclusion criteria (7 listed)
- Patient is female.
- Patient was evaluated for infertility between (and including) 1965 and 1988.
- Patient had a U.S. address at the time of evaluation for infertility.
- Patient was seen twice by the physician, or was seen once but had a referral from another physician.
- Patient's infertility was not due to gonadal dysgenesis or congenital abnormalities of the reproductive system.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cancer
Time frame: ongoing
Breast, endometrial, ovarian, thyroid, melanoma
1 secondary outcome
Mortality
Time frame: Ongoing
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 11 Jan 2024.
- Background: PubMed 7171506Bamford PN, Steele SJ. Uterine and ovarian carcinoma in a patient receiving gonadotrophin therapy. Case report. Br J Obstet Gynaecol. 1982 Nov;89(11):962-4. doi: 10.1111/j.1471-0528.1982.tb05067.x. No abstract available.
- Background: PubMed 3110335Carter ME, Joyce DN. Ovarian carcinoma in a patient hyperstimulated by gonadotropin therapy for in vitro fertilization: a case report. J In Vitro Fert Embryo Transf. 1987 Apr;4(2):126-8. doi: 10.1007/BF01555453. No abstract available.
- Background: PubMed 7124357Atlas M, Menczer J. Massive hyperstimulation and borderline carcinoma of the ovary. A possible association. Acta Obstet Gynecol Scand. 1982;61(3):261-3. doi: 10.3109/00016348209156568.
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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.
Gretchen Benson, Ph.D. principal investigator
National Cancer Institute (NCI)
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 Ovarian Cancer and Breast Cancer, run by National Cancer Institute (NCI) 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 7 inclusion and 0 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 11 Jan 2024. 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?
Cancer (time frame: ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00342446, which also lists 3 linked publications.
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 11 Jan 2024.