Breast CancerNCT04767607
Study of Prediction of Ovarian Reserve in Yong Breast Cancer Patients Treated With Chemotherapy
An observational study of Breast Cancer, run by International Peace Maternity and Child Health Hospital at 1 site in China.
Trial summary
The purpose of this study is to predict the ovarian reserve, especially premature ovarian insufficient (POI), in young breast cancer patients during chemotherapy treatment using ultrasensitive anti-Müllerian hormone (AMH) detection method. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 1 Jul 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: 200 premenopausal breast cancer female patients of age 18-50 treated in the International Peace Maternity and Child Health Hospital
Who may be able to join
- Female 18-50 years.
- Suffering from breast cancer.
- Treated with adjuvant or neoadjuvant chemotherapy.
- Having regular menstrual cycle before chemotherapy.
Who cannot join
- Bilateral oophorectomy or ovarian irradiation before enrollment.
- Prior chemotherapy.
- Oral contraceptives before enrollment.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
China1 site
The International Peace Maternity and Child Health Hospital
Shanghai, Shanghai Municipality, 200030
About this study
Official title: International Peace Maternity and Child Health Hospital (IPMCH) Affiliated to School of Medicine, Shanghai Jiaotong University, Shanghai, China
The purpose of this study is to predict the ovarian reserve, especially premature ovarian insufficient (POI), in young breast cancer patients during chemotherapy treatment using ultrasensitive anti-Müllerian hormone (AMH) detection method.
Read the detailed description
Young breast cancer women are often treated with adjuvant chemotherapy and neoadjuvant chemotherapy regiments include cyclophosphamide, anthracyclines and a taxane. These treatments can adversely affect ovarian function across the lifespan, causing premature menopause, infertility, and POI. AMH is currently the most robust marker of prediction of ovarian injury in cancer patients during chemotherapy in compare with other sexual hormone marker (such as follicle stimulating hormone (FSH), inhibin B) and ovarian volume, and is a more convenient way of prediction of ovarian reserve compare antral follicle count (AFC). But most of the patients' AMH levels become undetectable (using common AMH kits) after several cycle of chemotherapy, and some of these patients' AMH levels will maintained at a low level after chemotherapy, while others will recover. Using the ultrasensitive AMH detection method is expected to accurately assess the ovarian reserve during the chemotherapy treatment, predicting the risk of ovarian failure, and providing patients with ovarian and fertility function protection recommendations, such as using GnRHa regents during treatment and providing assisted reproductive technology consultants.
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Chemotherapy, ovarian reserve
- Medical subject headings
- Breast Neoplasms
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 |
|---|---|---|
| Breast cancer plus chemotherapy | Patients of the group will receive chemotherapy treatment. | |
| Breast cancer without chemotherapy | Patients of the group will not receive chemotherapy treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the trend of anti-Müllerian hormone (AMH) level at chemotherapy process and post-chemotherapy in breast cancer patients.
Serum anti-Müllerian hormone (AMH) concentration can be measured on any day during the menstrual cycle. Serum AMH will be measured at each chemotherapy administration and 1 year post-chemotherapy.
Measured: 1 year.
Secondary outcomes (1)
To evaluate the trend of Follicle-Stimulating Hormone (FSH) level at chemotherapy process and post-chemotherapy in breast cancer patients.
Serm FSH concentration will be measured at each chemotherapy process and 1 year post-chemotherapy.
Measured: 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Jun 2020
- Primary completion1 Jul 2022
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Peace Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- School of Biomedical Engineering, Shanghai Jiao Tong University
- Responsible party
- Principal investigator, Dongmei Lai, International Peace Maternity and Child Health Hospital
- Investigators
- Dongmei Lai, M.D., Principal investigator, The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767607
- Sponsor's protocol ID
- GFY202001
- Status last verified
- Mar 2024
- First submitted
- 26 Jan 2021
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The public can require the data and protocol from clinicaltrials.gov posted by investigator.
Publications
Dezellus A, Barriere P, Campone M, Lemanski C, Vanlemmens L, Mignot L, Delozier T, Levy C, Bendavid C, Debled M, Bachelot T, Jouannaud C, Loustalot C, Mouret-Reynier MA, Gallais-Umbert A, Masson D, Freour T. Prospective evaluation of serum anti-Mullerian hormone dynamics in 250 women of reproductive age treated with chemotherapy for breast cancer. Eur J Cancer. 2017 Jul;79:72-80. doi: 10.1016/j.ejca.2017.03.035. Epub 2017 Apr 29.
PubMed 28463758Freour T, Barriere P, Masson D. Anti-mullerian hormone levels and evolution in women of reproductive age with breast cancer treated with chemotherapy. Eur J Cancer. 2017 Mar;74:1-8. doi: 10.1016/j.ejca.2016.12.008. Epub 2017 Jan 28.
PubMed 28135602Lie Fong S, Lugtenburg PJ, Schipper I, Themmen AP, de Jong FH, Sonneveld P, Laven JS. Anti-mullerian hormone as a marker of ovarian function in women after chemotherapy and radiotherapy for haematological malignancies. Hum Reprod. 2008 Mar;23(3):674-8. doi: 10.1093/humrep/dem392. Epub 2008 Jan 23.
PubMed 18216040Kuang X, Ji M, Tang Y, Wang Q, Pan S, He J, Anderson RA, Wang BS, Xu H, Lai D. Monitoring ovarian reserve dynamics via a high-sensitivity anti-Mullerian hormone assay in premenopausal breast cancer patients undergoing chemotherapy. Hum Reprod. 2026 Aug 28:deag136. doi: 10.1093/humrep/deag136. Online ahead of print.
PubMed 42664366
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Peace Maternity and Child Health Hospital (IPMCH) Affiliated to School of Medicine, Shanghai Jiaotong University, Shanghai, China
- ClinicalTrials.gov ID
- NCT04767607
- Acronym / sponsor ID
- GFY202001
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Chemotherapy, ovarian reserve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- International Peace Maternity and Child Health HospitalUniversity, hospital or other
- Collaborators
- School of Biomedical Engineering, Shanghai Jiao Tong University
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 23 Feb 2021 (actual)
- 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.
The purpose of this study is to predict the ovarian reserve, especially premature ovarian insufficient (POI), in young breast cancer patients during chemotherapy treatment using ultrasensitive anti-Müllerian hormone (AMH) detection method.
Detailed description
Young breast cancer women are often treated with adjuvant chemotherapy and neoadjuvant chemotherapy regiments include cyclophosphamide, anthracyclines and a taxane. These treatments can adversely affect ovarian function across the lifespan, causing premature menopause, infertility, and POI. AMH is currently the most robust marker of prediction of ovarian injury in cancer patients during chemotherapy in compare with other sexual hormone marker (such as follicle stimulating hormone (FSH), inhibin B) and ovarian volume, and is a more convenient way of prediction of ovarian reserve compare antral follicle count (AFC). But most of the patients' AMH levels become undetectable (using common AMH kits) after several cycle of chemotherapy, and some of these patients' AMH levels will maintained at a low level after chemotherapy, while others will recover. Using the ultrasensitive AMH detection method is expected to accurately assess the ovarian reserve during the chemotherapy treatment, predicting the risk of ovarian failure, and providing patients with ovarian and fertility function protection recommendations, such as using GnRHa regents during treatment and providing assisted reproductive technology consultants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast cancer plus chemotherapy | – | –Patients of the group will receive chemotherapy treatment. |
| Breast cancer without chemotherapy | – | –Patients of the group will not receive chemotherapy treatment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 200 premenopausal breast cancer female patients of age 18-50 treated in the International Peace Maternity and Child Health Hospital
Key inclusion criteria (4 listed)
- Female 18-50 years.
- Suffering from breast cancer.
- Treated with adjuvant or neoadjuvant chemotherapy.
- Having regular menstrual cycle before chemotherapy.
Key exclusion criteria (4 listed)
- Bilateral oophorectomy or ovarian irradiation before enrollment.
- Prior chemotherapy.
- Oral contraceptives before enrollment.
- Pregnancy or lactation.
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
To evaluate the trend of anti-Müllerian hormone (AMH) level at chemotherapy process and post-chemotherapy in breast cancer patients.
Time frame: 1 year.
Serum anti-Müllerian hormone (AMH) concentration can be measured on any day during the menstrual cycle. Serum AMH will be measured at each chemotherapy administration and 1 year post-chemotherapy.
1 secondary outcome
To evaluate the trend of Follicle-Stimulating Hormone (FSH) level at chemotherapy process and post-chemotherapy in breast cancer patients.
Time frame: 1 year.
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 6 Mar 2024.
- Background: PubMed 28463758Dezellus A, Barriere P, Campone M, Lemanski C, Vanlemmens L, Mignot L, Delozier T, Levy C, Bendavid C, Debled M, Bachelot T, Jouannaud C, Loustalot C, Mouret-Reynier MA, Gallais-Umbert A, Masson D, Freour T. Prospective evaluation of serum anti-Mullerian hormone dynamics in 250 women of reproductive age treated with chemotherapy for breast cancer. Eur J Cancer. 2017 Jul;79:72-80. doi: 10.1016/j.ejca.2017.03.035. Epub 2017 Apr 29.
- Background: PubMed 28135602Freour T, Barriere P, Masson D. Anti-mullerian hormone levels and evolution in women of reproductive age with breast cancer treated with chemotherapy. Eur J Cancer. 2017 Mar;74:1-8. doi: 10.1016/j.ejca.2016.12.008. Epub 2017 Jan 28.
- Background: PubMed 18216040Lie Fong S, Lugtenburg PJ, Schipper I, Themmen AP, de Jong FH, Sonneveld P, Laven JS. Anti-mullerian hormone as a marker of ovarian function in women after chemotherapy and radiotherapy for haematological malignancies. Hum Reprod. 2008 Mar;23(3):674-8. doi: 10.1093/humrep/dem392. Epub 2008 Jan 23.
- Derived from this study: PubMed 42664366Kuang X, Ji M, Tang Y, Wang Q, Pan S, He J, Anderson RA, Wang BS, Xu H, Lai D. Monitoring ovarian reserve dynamics via a high-sensitivity anti-Mullerian hormone assay in premenopausal breast cancer patients undergoing chemotherapy. Hum Reprod. 2026 Aug 28:deag136. doi: 10.1093/humrep/deag136. Online ahead of print.
- Individual participant dataSharing planned: Yes. The public can require the data and protocol from clinicaltrials.gov posted by investigator.
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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.
Dongmei Lai, M.D. principal investigator
The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University
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 Breast Cancer, run by International Peace Maternity and Child Health Hospital at 1 site in China.
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 4 inclusion and 4 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 6 Mar 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 China. 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?
To evaluate the trend of anti-Müllerian hormone (AMH) level at chemotherapy process and post-chemotherapy in breast cancer patients. (time frame: 1 year.). 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 NCT04767607, which also lists 4 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 6 Mar 2024.