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NCT Number: NCT06360471

Fertility Preservation and Pregnancy and Offspring Health Outcomes in Female Cancer

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

fertility preservation

Other

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

Primary outcomes

  1. 5-year cumulative live birth rate

    Time frame: 5 years

    5-year cumulative live birth rate for female patients who reproduce

Secondary outcomes

  1. Ovarian function(AMH levels)

    Time frame: 5 years

    AMH levels of all patients

  2. Ovarian function(AFC counts)

    Time frame: 5 years

    AFC counts of of all patients

  3. Newborn malformation rate

    Time frame: 5 years

    Newborn malformation rate for female patients who reproduced

  4. Tumor recurrence rate

    Time frame: 5 years

    Tumor recurrence rate of all participants

  5. Tumor survival rate

    Time frame: 5 years

    Tumor survival rate of all participants

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2032
First posted
Apr 11, 2024
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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