About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 population
2800 female cancer patients who have fertility desire
Trial design
Cohort
Prospective
Treatments tested in this trial
fertility preservation
Other interventionIf a patient have a desire to fertility preservation, oocyte freezing or embryo freezing will be offered.
Treatment groups
Trial outcomes
Primary outcomes
5-year cumulative live birth rate
5-year cumulative live birth rate for female patients who reproduce
Secondary outcomes
Ovarian function(AMH levels)
AMH levels of all patients
Ovarian function(AFC counts)
AFC counts of of all patients
Newborn malformation rate
Newborn malformation rate for female patients who reproduced
Tumor recurrence rate
Tumor recurrence rate of all participants
Sponsors and contacts
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