Exploring fertility preservation and health outcomes in female cancer patients
Fertility Preservation and Pregnancy and Offspring Health Outcomes in Female Cancer Patients: A Multicenter, Prospective, Cohort Study
This study is testing if women with cancer who take steps to save their ability to have children before treatment have better chances of having healthy babies compared to those who don’t and to women without cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2800 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Female |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06360471 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the differences in cumulative live birth rates and maternal and child health outcomes between female cancer patients who undergo fertility preservation before anti-tumor treatment and those who do not, as well as non-cancer patients undergoing assisted reproductive technology or natural pregnancy. The study will enroll 2800 women diagnosed with various malignant cancers who wish to preserve their fertility. Participants will be observed over the long term to assess the impact of fertility preservation on reproductive outcomes and offspring health. Statistical analyses will be conducted to evaluate the data collected.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 20-40 diagnosed with malignant cancers who desire to preserve their fertility.
Not a fit: Patients with congenital or acquired uterine abnormalities, severe intrauterine adhesions, or those with contraindications to assisted reproductive technology may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the benefits of fertility preservation for female cancer patients, potentially improving their reproductive outcomes and offspring health.
How similar studies have performed: Other studies have shown promising results regarding fertility preservation in cancer patients, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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; 2. Having a desire for future fertility(including women who have already given birth); 3. 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); 4. Consent. Exclusion Criteria: 1. Patients with congenital or acquired uterine abnormalities, severe intrauterine adhesions, and other diseases that have a clear impact on pregnancy; 2. Those with assisted reproductive technology and pregnancy contraindications; 3. Tumors that are not suitable for pregnancy after multidisciplinary discussions on tumor fertility; 4. Clinical diagnosis of POI (premature ovarian insufficiency).
Where this trial is running
Nanjing, Jiangsu
- Clinical Center of Reproductive Medicine of First Affiliated Hospital with Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.