Fertility Preservation and Pregnancy and Offspring Health Outcomes in Female Cancer

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06360471
• Other study ID #: FS-FMC
• Status: Recruiting
• Start date: October 1, 2023
• Est. completion date: October 1, 2032

Study information

• Verified date: April 2024
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2800
• Est. completion date: October 1, 2032
• Est. primary completion date: October 1, 2027
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cancer
• Fertility Issues
• Infertility

Intervention

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

Locations

Country	Name	City	State
China	Clinical Center of Reproductive Medicine of First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-year cumulative live birth rate	5-year cumulative live birth rate for female patients who reproduce	5 years
Secondary	Ovarian function(AMH levels)	AMH levels of all patients	5 years
Secondary	Ovarian function(AFC counts)	AFC counts of of all patients	5 years
Secondary	Newborn malformation rate	Newborn malformation rate for female patients who reproduced	5 years
Secondary	Tumor recurrence rate	Tumor recurrence rate of all participants	5 years
Secondary	Tumor survival rate	Tumor survival rate of all participants	5 years