Fertility Preservation and Pregnancy and Offspring Health Outcomes in Female Cancer

April 15, 2024 updated by: The First Affiliated Hospital with Nanjing Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

2800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Clinical Center of Reproductive Medicine of First Affiliated Hospital with Nanjing Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

2800 female cancer patients who have fertility desire

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fertility preservation
patients who choose fertility preservation
Other: fertility preservation
If a patient have a desire to fertility preservation, oocyte freezing or embryo freezing will be offered.
Observation
patients who choose observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year cumulative live birth rate
Time Frame: 5 years
5-year cumulative live birth rate for female patients who reproduce
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ovarian function(AMH levels)
Time Frame: 5 years
AMH levels of all patients
5 years
Ovarian function(AFC counts)
Time Frame: 5 years
AFC counts of of all patients
5 years
Newborn malformation rate
Time Frame: 5 years
Newborn malformation rate for female patients who reproduced
5 years
Tumor recurrence rate
Time Frame: 5 years
Tumor recurrence rate of all participants
5 years
Tumor survival rate
Time Frame: 5 years
Tumor survival rate of all participants
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2032

Study Registration Dates

First Submitted

April 7, 2024

First Submitted That Met QC Criteria

April 7, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FS-FMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol can be shared

IPD Sharing Time Frame

5 years

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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