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Completed

NCT Number: NCT02518191

Effects of GnRHa on Ovarian Function Against Chemotherapy-induced-gonadotoxicity

This prospective randomized controlled study is conducted to analyze the effect of Goserelin on ovarian function in women with breast cancer in China.

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Key information

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Premenopausal women 18 to 49 years of age are eligible for enrollment
  • Patients have operable stage I to IIIA breast cancer for which treatment with adjuvant or neoadjuvant cyclophosphamide-containing chemotherapy was planned.
  • Eligible participants had taken no estrogens, antiestrogens, selective estrogen-receptor modulators, aromatase inhibitors, or hormonal contraceptives within the month before enrollment.
  • Human chorionic gonadotropin negative by urine test before entering the group.
  • Informed consent, understanding and compliance with the requirements of the study.
  • No significant chronic disease and any organ dysfunction.

Exclusion criteria

  • Exceptions were made for the use of hormonal contraception in women younger than 35 years of age that was discontinued before randomization.
  • Use of hormonal treatment for up to 2 months for the purposes of in vitro fertilization and cryopreservation of embryos or oocytes before randomization.
  • Patients with metastatic lesions or history of bilateral ovariectomy,ovarian radiation were excluded.
  • Patients received previous adjuvant endocrine therapy for breast cancer are not suitable to this trial.
  • Patients with uterine and/or adnexal diseases needing medical or surgical treatment are not suitable.
  • Allergic to active or inactive excipients of GnRHa is an exclusion criterion.

Treatment and study plan

GnRHa

Drug

3.6mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy.

Other names: goserelin

Primary outcomes

  1. Number of Participants With Premature Ovarian Insufficiency

    Time frame: 1 years

    The serum levels of anti-Müllerian hormone (AMH) were measured using human AMH ELISA kit (11351, Biofine)). POI (premature ovarian insufficiency) was defined as AMH<0.5ng/mL in this study.

Secondary outcomes

  1. Survival Rate

    Time frame: 5 years

    Overall Survival & Tumor Free Survival

Sponsors and collaborators

Lead sponsor

Xiangyun Zong

Other

Collaborators

  • Zhejiang Cancer Hospital

Registry information

Official study title

Effects of GnRHa on Ovarian Function Against Chemotherapy-induced-gonadotoxicity in Women With Breast Cancer in China

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Aug 7, 2015
Registry last updated
Jun 11, 2021

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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