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Fertility Preservation and Pregnancy and Offspring Health Outcomes in Female Cancer

Fertility Preservation and Pregnancy and Offspring Health Outcomes in Female Cancer Patients: A Multicenter, Prospective, Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06360471
Enrollment
2800
Registered
2024-04-11
Start date
2023-10-01
Completion date
2032-10-01
Last updated
2024-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Fertility Issues

Keywords

fertility preservation, cancer

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.

Interventions

OTHERfertility preservation

If a patient have a desire to fertility preservation, oocyte freezing or embryo freezing will be offered.

Sponsors

The First Affiliated Hospital with Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years

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).

Design outcomes

Primary

MeasureTime frameDescription
5-year cumulative live birth rate5 years5-year cumulative live birth rate for female patients who reproduce

Secondary

MeasureTime frameDescription
Ovarian function(AMH levels)5 yearsAMH levels of all patients
Ovarian function(AFC counts)5 yearsAFC counts of of all patients
Newborn malformation rate5 yearsNewborn malformation rate for female patients who reproduced
Tumor recurrence rate5 yearsTumor recurrence rate of all participants
Tumor survival rate5 yearsTumor survival rate of all participants

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026