Fertility Preservation and Pregnancy and Offspring Health Outcomes in Female Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-40
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial population

2800 female cancer patients who have fertility desire

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • fertility preservation

    Other intervention

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

Treatment groups

2,800 Participants
are divided into 2 treatment groups
Group A: Fertility preservation1 intervention
Group B: Observation0 interventions

Trial outcomes

Primary outcomes

1

5-year cumulative live birth rate

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

Time frame
5 years

Secondary outcomes

1

Ovarian function(AMH levels)

AMH levels of all patients

Time frame
5 years
2

Ovarian function(AFC counts)

AFC counts of of all patients

Time frame
5 years
3

Newborn malformation rate

Newborn malformation rate for female patients who reproduced

Time frame
5 years
4

Tumor recurrence rate

Tumor recurrence rate of all participants

Time frame
5 years

Other outcomes

Sponsors and contacts

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