Actively Recruiting
Fertility Preservation and Pregnancy and Offspring Health Outcomes in Female Cancer Patients: A Multicenter, Prospective, Cohort Study
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-04-16
2800
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether fertility preservation affects the live birth rate and the health of mothers and their children among women diagnosed with cancer who wish to have children. The study compares cancer patients who undergo fertility preservation before receiving anti-tumor treatment to those who do not, as well as to women without cancer who conceive naturally or use assisted reproductive technology. This research is being conducted at the Clinical Center of Reproductive Medicine, First Affiliated Hospital of Nanjing Medical University, enrolling 2800 women with various malignant cancers such as breast, hematological, gynecological, nasopharyngeal, and colorectal cancers. Participants may choose to undergo fertility preservation procedures like oocyte or embryo freezing if they wish, or they may opt for observation without preservation. The study follows these groups over time to record outcomes related to cumulative live births, pregnancy complications, and the health of offspring. The observation period includes long-term monitoring to assess the effects of anti-tumor treatments on fertility and child health. Women involved in the study will be followed for up to five years, during which ovarian function, newborn malformation rates, tumor recurrence, and survival rates will be monitored. Data collection includes clinical evaluations and health assessments of both mothers and children. Statistical analysis will be conducted to compare outcomes across groups, helping to understand the impact of fertility preservation in cancer patients who desire future pregnancies.
CONDITIONS
Brief Title
Fertility Preservation and Pregnancy and Offspring Health Outcomes in Female Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women diagnosed with malignant tumors such as breast cancer, hematological disease/lymphoma, gynecological tumors (including ovarian and borderline tumors), nasopharyngeal cancer, colorectal cancer, or other cancers needing anti-tumor treatment
- Desire for future fertility, including women who have already given birth
- Age between 20 and 40 years old (patients planning egg freezing up to 35 years old; embryo freezing up to 40 years old)
- Provide informed consent
You will not qualify if you...
- Congenital or acquired uterine abnormalities or severe intrauterine adhesions that clearly impact pregnancy
- Contraindications to assisted reproductive technology or pregnancy
- Tumors unsuitable for pregnancy based on multidisciplinary tumor fertility discussions
- Clinical diagnosis of premature ovarian insufficiency (POI)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants choose either fertility preservation involving oocyte or embryo freezing before anti-tumor treatment or long-term observation without preservation.
Visits scheduled according to participant's choice and clinical follow-up
Duration - Up to 5 years
Participants are observed for fertility outcomes, pregnancy, offspring health, and tumor status over five years.
Periodic visits over 5 years for assessments
Trial Site Locations
Total: 1 location
1
Clinical Center of Reproductive Medicine of First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here