Clinical trial · Observational
Study of Preservation of Ovarian Reserve During Chemotherapy for Young Breast Cancer Patients
Effect of Goserelin on the Protection of Ovarian Reserve During (Neo)Adjuvant Chemotherapy for Young Breast Cancer Patients: A Prospective Cohort Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess efficacy of gonadotropin-releasing hormone agonist (goserelin) on the preservation of ovarian reserve function in young breast cancer patients treated with (neo)adjuvant chemotherapy by serial measuring ovarian reserve markers (AMH and AFC.etc) before and after chemotherapy and long-term pregnancy outcomes. Meanwhile, to evaluate the safety of this protective approach in young breast cancer patients by disease-free survival (DFS) and overall survival (OS) outcomes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Goserelin 3.6 MG | Drug | Goserelin | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Chemotherapy plus GnRHa
- description
- Patients of the group will receive (neo)chemotherapy plus GnRHa ( Goserelin 3.6mg will be administered every 28 days by subcutaneous injection starting at least 7-14 days before the first cycle of chemotherapy and continued throughout chemotherapy duration).
- interventionNames
- Drug: Goserelin 3.6 MG
- label
- Chemotherapy
- description
- Patients of the group will receive (neo)chemotherapy merely.
Primary outcomes (1)
- measure
- Recovery of serum AMH value(≥0.5ng/ml) in 2 years of post-chemotherapy
- timeFrame
- Phlebotomy will be carried out at 2 years (one month ahead or one month delayed could be accepted) after chemotherapy in both groups.
- description
- AMH can be measured on any day during the menstrual cycle.Serum AMH concentrations will be measured using the AMH Gen II ELISA, according to the manufacturer's instructions
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: For inclusion in the study patients must fulfil all of the following criteria: 1. Aged 45 years or younger 2. Have regular menstrual cycle 3. Newly diagnosed early-stage breast cancer (stages I to III) 4. Planned (neo)adjuvant chemotherapy 5. Signed informed consent document on file Exclusion Criteria: Any of the following is regarded as a criterion for exclusion from the study: 1. Pregnancy or lactation 2. Oral contraceptives before enrollment 3. Prior chemotherapy 4. Bilateral oophorectomy or ovarian irradiation before enrollment 5. History of other cancers 6. GnRHa -containing adjuvant endocrine therapy
References
Publications (1)
- BACKGROUNDWang S, Pei L, Hu T, Jia M, Wang S. Protective effect of goserelin on ovarian reserve during (neo)adjuvant chemotherapy in young breast cancer patients: a prospective cohort study in China. Hum Reprod. 2021 Mar 18;36(4):976-986. doi: 10.1093/humrep/deaa349. PMID 33411897