Clinical trial NCT06360471: Fertility Preservation and Pregnancy and Offspring Health Outcomes in Female Cancer
Official title: Fertility Preservation and Pregnancy and Offspring Health Outcomes in Female Cancer Patients: A Multicenter, Prospective, Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fertility Issues
Cancer
Keywords: fertility preservation
cancer
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 2800
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 2800 female cancer patients who have fertility desire

Brief 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 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.

Eligibility 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).

Primary outcomes:
measure: 5-year cumulative live birth rate
timeFrame: 5 years
Secondary outcomes:
measure: Ovarian function(AMH levels)
timeFrame: 5 years
measure: Ovarian function(AFC counts)
timeFrame: 5 years
measure: Newborn malformation rate
timeFrame: 5 years
measure: Tumor recurrence rate
timeFrame: 5 years
measure: Tumor survival rate
timeFrame: 5 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Clinical Center of Reproductive Medicine of First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
Study officials:
References: