Fertility IssuesNCT06360471
Fertility Preservation and Pregnancy and Offspring Health Outcomes in Female Cancer
An observational study of Fertility Issues and Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
To explore whether there is a significant difference in the cumulative live birth rate and maternal and child health outcomes between cancer patients who undergo or do not undergo fertility preservation before receiving anti-tumor treatment and non-cancer patients who undergo assisted reproductive technology… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Fertility Issues, Cancer
- What is being tested?
- fertility preservation
- How many people
- 2,800 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 1 Oct 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- Women only
- Adult
Study population: 2800 female cancer patients who have fertility desire
Who may be able to join
- Tumor confirmed (main focus: breast cancer, hematological disease/lymphoma, gynecological tumor (ovarian cancer), boundary tumors, nasopharyngeal cancer, colorectal cancer, and other tumors that require anti-tumor treatment;
- Having a desire for future fertility(including women who have already given birth);
- Age: 20-40 years old (patients planning to freeze their eggs are ≤35 years old, and those planning to freeze their embryos are ≤40 years old);
- Consent.
Who cannot join
- Patients with congenital or acquired uterine abnormalities, severe intrauterine adhesions, and other diseases that have a clear impact on pregnancy;
- Those with assisted reproductive technology and pregnancy contraindications;
- Tumors that are not suitable for pregnancy after multidisciplinary discussions on tumor fertility;
- Clinical diagnosis of POI (premature ovarian insufficiency).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Clinical Center of Reproductive Medicine of First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210000
Xiang Ma, MD. PHD, +8618001581878, sxmaxiang@126.com
Nan Lu, +8615950476023, nancylu1993@126.com
About this study
Official title: Fertility Preservation and Pregnancy and Offspring Health Outcomes in Female Cancer Patients: A Multicenter, Prospective, Cohort Study
To explore whether there is a significant difference in the cumulative live birth rate and maternal and child health outcomes between cancer patients who undergo or do not undergo fertility preservation before receiving anti-tumor treatment and non-cancer patients who undergo assisted reproductive technology treatment/natural pregnancy.
This study will be conducted in the Clinical Center of Reproductive Medicine, First Affiliated Hospital of Nanjing Medical University. 2800 women diagnosed with malignant cancers who has desire to reproduce will be enrolled in this study.
Statistical analysis of the data will be performed.
Read the detailed description
The number of new cancer cases among Chinese women in 2020 will be 2.09 million, showing a trend in younger age at the time of diagnosis. Incomplete statistics show that 25%~30% of young breast cancer patients in China Need for fertility preservation. In this study, we want to answer the question: Does fertility preservation affect the prognosis in female cancer patients.
This study will be conducted in the Clinical Center of Reproductive Medicine, First Affiliated Hospital of Nanjing Medical University. 2800 women diagnosed with malignant cancers who has desire to reproduce will be enrolled in this study.
If a female tumor patients (focusing on: breast cancer, hematological diseases/lymphoma, gynecological tumors (ovarian borderline tumors, etc.), nasopharyngeal cancer, colorectal cancer, etc.) have a desire to reproduce in the future, she would considered for enrollment. After being admitted into this study, according to the patients'own will, she will receive long term observation or fertility preservation followed by long term observation. Cumulative live birth rate, perinatal and perinatal complications, and offspring health of women who have or have not received fertility preservation before anti-tumor treatment and who have no tumor and who normally receive assisted reproductive technology treatment/natural pregnancy are all recorded, to assess the impact of the current new anti-tumor treatment on female fertility and offspring health.
- Conditions
- Fertility Issues, Cancer
- Being tested
- fertility preservation
- Keywords
- fertility preservation, cancer
- Medical subject headings
- Infertility, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fertility preservationOther
If a patient have a desire to fertility preservation, oocyte freezing or embryo freezing will be offered.
| Study group | Role | What they receive |
|---|---|---|
| Fertility preservation | patients who choose fertility preservation Receives: Other: fertility preservation | |
| Observation | patients who choose observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year cumulative live birth rate
5-year cumulative live birth rate for female patients who reproduce
Measured: 5 years
Secondary outcomes (5)
Ovarian function(AMH levels)
AMH levels of all patients
Measured: 5 years
Ovarian function(AFC counts)
AFC counts of of all patients
Measured: 5 years
Newborn malformation rate
Newborn malformation rate for female patients who reproduced
Measured: 5 years
Tumor recurrence rate
Tumor recurrence rate of all participants
Measured: 5 years
Tumor survival rate
Tumor survival rate of all participants
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Oct 2023
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility IssuesStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- 2,800 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360471
- Sponsor's protocol ID
- FS-FMC
- Status last verified
- Apr 2024
- First submitted
- 7 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol can be shared
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility Preservation and Pregnancy and Offspring Health Outcomes in Female Cancer Patients: A Multicenter, Prospective, Cohort Study
- ClinicalTrials.gov ID
- NCT06360471
- Acronym / sponsor ID
- FS-FMC
- Conditions
- Fertility Issues, Cancer
- Keywords
- fertility preservation, cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,800 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2032 (estimated)
- First posted
- 11 Apr 2024 (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.
To explore whether there is a significant difference in the cumulative live birth rate and maternal and child health outcomes between cancer patients who undergo or do not undergo fertility preservation before receiving anti-tumor treatment and non-cancer patients who undergo assisted reproductive technology treatment/natural pregnancy.
This study will be conducted in the Clinical Center of Reproductive Medicine, First Affiliated Hospital of Nanjing Medical University. 2800 women diagnosed with malignant cancers who has desire to reproduce will be enrolled in this study.
Statistical analysis of the data will be performed.
Detailed description
The number of new cancer cases among Chinese women in 2020 will be 2.09 million, showing a trend in younger age at the time of diagnosis. Incomplete statistics show that 25%~30% of young breast cancer patients in China Need for fertility preservation. In this study, we want to answer the question: Does fertility preservation affect the prognosis in female cancer patients.
This study will be conducted in the Clinical Center of Reproductive Medicine, First Affiliated Hospital of Nanjing Medical University. 2800 women diagnosed with malignant cancers who has desire to reproduce will be enrolled in this study.
If a female tumor patients (focusing on: breast cancer, hematological diseases/lymphoma, gynecological tumors (ovarian borderline tumors, etc.), nasopharyngeal cancer, colorectal cancer, etc.) have a desire to reproduce in the future, she would considered for enrollment. After being admitted into this study, according to the patients'own will, she will receive long term observation or fertility preservation followed by long term observation. Cumulative live birth rate, perinatal and perinatal complications, and offspring health of women who have or have not received fertility preservation before anti-tumor treatment and who have no tumor and who normally receive assisted reproductive technology treatment/natural pregnancy are all recorded, to assess the impact of the current new anti-tumor treatment on female fertility and offspring health.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fertility preservation | – | Other: fertility preservationpatients who choose fertility preservation |
| Observation | – | –patients who choose observation |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- 2800 female cancer patients who have fertility desire
Key inclusion criteria (4 listed)
- Tumor confirmed (main focus: breast cancer, hematological disease/lymphoma, gynecological tumor (ovarian cancer), boundary tumors, nasopharyngeal cancer, colorectal cancer, and other tumors that require anti-tumor treatment;
- Having a desire for future fertility(including women who have already given birth);
- Age: 20-40 years old (patients planning to freeze their eggs are ≤35 years old, and those planning to freeze their embryos are ≤40 years old);
- Consent.
Key exclusion criteria (4 listed)
- Patients with congenital or acquired uterine abnormalities, severe intrauterine adhesions, and other diseases that have a clear impact on pregnancy;
- Those with assisted reproductive technology and pregnancy contraindications;
- Tumors that are not suitable for pregnancy after multidisciplinary discussions on tumor fertility;
- Clinical diagnosis of POI (premature ovarian insufficiency).
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 |
|---|---|---|
| fertility preservationIf a patient have a desire to fertility preservation, oocyte freezing or embryo freezing will be offered. | Other | Fertility preservation |
Primary outcome
5-year cumulative live birth rate
Time frame: 5 years
5-year cumulative live birth rate for female patients who reproduce
5 secondary outcomes
Ovarian function(AMH levels)
Time frame: 5 years
Ovarian function(AFC counts)
Time frame: 5 years
Newborn malformation rate
Time frame: 5 years
Tumor recurrence rate
Time frame: 5 years
Tumor survival rate
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: Yes. Study protocol can be shared
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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.
Clinical Center of Reproductive Medicine of First Affiliated Hospital with Nanjing Medical University
Nanjing, China
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 Fertility Issues and Cancer, run by The First Affiliated Hospital with Nanjing Medical University 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: looking for participants now, as of the sponsor's last update on 16 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year cumulative live birth rate (time frame: 5 years). 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 16 Apr 2024.