Gonadotropin Releasing Hormone AgonistsNCT07127315
Gonadotropin-Releasing Hormone Agonists Benefit in Preserving the Ovarian Function in Premenopausal Breast Cancer Patients During Chemotherapy
A study testing Gonadotropin-releasing hormone agonist and Chemotherapy in people with Gonadotropin Releasing Hormone Agonists and Ovarian Function, run by Helwan University at 1 site in Egypt.
Trial summary
The purpose of this study is to investigate the benefits of gonadotropin-releasing hormone agonist administration during chemotherapy on preserving ovarian function and Fertility in Premenopausal breast cancer patients, as assessed by anti-mullerian hormone levels, luteinizing hormone (LH), follicle-stimulating… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gonadotropin Releasing Hormone Agonists, Ovarian Function, Premenopausal
- What is being tested?
- Gonadotropin-releasing hormone agonist and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal female patients 18-45 years.
- Female patients with pathologically confirmed breast cancer and receiving a chemotherapy regimen, either adjuvant or neoadjuvant, containing a gonadotoxic agent.
- Female patients with performance status (PS) ≤ 2.
Who cannot join
- All female Patients with metastatic cancer.
- Patients underwent total abdominal hysterectomy and bilateral salpingo-oophorectomy, or patients received radiotherapy on the pelvis.
- Patient with end-organ failure.
- Patients with performance status >2.
- Male with breast cancer.
- Post-menopausal females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Concurrent Goserelin During Chemotherapy for Ovarian Function Preservation in Premenopausal Breast Cancer: An Open-Label Randomized Trial
The purpose of this study is to investigate the benefits of gonadotropin-releasing hormone agonist administration during chemotherapy on preserving ovarian function and Fertility in Premenopausal breast cancer patients, as assessed by anti-mullerian hormone levels, luteinizing hormone (LH), follicle-stimulating hormone (FSH), and estradiol (E2) levels.
Read the detailed description
The annually estimated number of females diagnosed with cancer is about 6.6 million, 10% of whom are premenopausal.
To minimize the risk of ovarian dysfunction and infertility for these patients, ovarian reserve differs widely from one female to another, but it could be assessed by Ultrasound to reveal antral follicle count (AFC). Also, the hormonal levels of anti-Müllerian hormone (AMH), estradiol (E2), and follicle-stimulating hormone FSH are valuable indicators for fertility.
- Conditions
- Gonadotropin Releasing Hormone Agonists, Ovarian Function, Premenopausal, Breast Cancer, Chemotherapy
- Being tested
- Gonadotropin-releasing hormone agonist, Chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gonadotropin-releasing hormone agonistDrug
Patients received chemotherapy plus a gonadotropin-releasing hormone agonist.
ChemotherapyDrug
Patients received chemotherapy alone.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients received chemotherapy with concurrent Goserelin 3.6 mg subcutaneously every 28 days Receives: Drug: Gonadotropin-releasing hormone agonist |
| Control group | Active comparator | Patients received chemotherapy alone. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-mullerian hormone level
Anti-mullerian hormone level was calculated.
Measured: Immediately post-procedure (Up to 1 hour)
Secondary outcomes (4)
Follicle-stimulating hormone level
Follicle-stimulating hormone level was calculated.
Measured: Immediately post-procedure (Up to 1 hour)
Estradiol level
Estradiol (E2) level was calculated.
Measured: Immediately post-procedure (Up to 1 hour)
Disease-free survival
Disease-free survival (DFS) was calculated.
Measured: 2 years post-procedure
Overall survival
Overall survival (OS) was calculated.
Measured: 2 years post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Jun 2022
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gonadotropin Releasing Hormone AgonistsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Mohsen Kamal, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127315
- Sponsor's protocol ID
- 51-2022
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Goserelin During Chemotherapy for Ovarian Function Preservation in Premenopausal Breast Cancer: An Open-Label Randomized Trial
- ClinicalTrials.gov ID
- NCT07127315
- Acronym / sponsor ID
- 51-2022
- Conditions
- Gonadotropin Releasing Hormone Agonists, Ovarian Function, Premenopausal, Breast Cancer, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the benefits of gonadotropin-releasing hormone agonist administration during chemotherapy on preserving ovarian function and Fertility in Premenopausal breast cancer patients, as assessed by anti-mullerian hormone levels, luteinizing hormone (LH), follicle-stimulating hormone (FSH), and estradiol (E2) levels.
Detailed description
The annually estimated number of females diagnosed with cancer is about 6.6 million, 10% of whom are premenopausal.
To minimize the risk of ovarian dysfunction and infertility for these patients, ovarian reserve differs widely from one female to another, but it could be assessed by Ultrasound to reveal antral follicle count (AFC). Also, the hormonal levels of anti-Müllerian hormone (AMH), estradiol (E2), and follicle-stimulating hormone FSH are valuable indicators for fertility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Gonadotropin-releasing hormone agonistPatients received chemotherapy with concurrent Goserelin 3.6 mg subcutaneously every 28 days |
| Control group | Active comparator | Drug: ChemotherapyPatients received chemotherapy alone. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Premenopausal female patients 18-45 years.
- Female patients with pathologically confirmed breast cancer and receiving a chemotherapy regimen, either adjuvant or neoadjuvant, containing a gonadotoxic agent.
- Female patients with performance status (PS) ≤ 2.
Key exclusion criteria (6 listed)
- All female Patients with metastatic cancer.
- Patients underwent total abdominal hysterectomy and bilateral salpingo-oophorectomy, or patients received radiotherapy on the pelvis.
- Patient with end-organ failure.
- Patients with performance status >2.
- Male with breast cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gonadotropin-releasing hormone agonistPatients received chemotherapy plus a gonadotropin-releasing hormone agonist. | Drug | Intervention group |
| ChemotherapyPatients received chemotherapy alone. | Drug | Control group |
Primary outcome
Anti-mullerian hormone level
Time frame: Immediately post-procedure (Up to 1 hour)
Anti-mullerian hormone level was calculated.
4 secondary outcomes
Follicle-stimulating hormone level
Time frame: Immediately post-procedure (Up to 1 hour)
Estradiol level
Time frame: Immediately post-procedure (Up to 1 hour)
Disease-free survival
Time frame: 2 years post-procedure
Overall survival
Time frame: 2 years post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Gonadotropin Releasing Hormone Agonists
Not yet recruiting
Surgery and ART For Endometrioma
Ovarian Endometrioma, Infertility, Female
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gonadotropin-releasing hormone agonist and Chemotherapy in people with Gonadotropin Releasing Hormone Agonists and Ovarian Function, run by Helwan University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-mullerian hormone level (time frame: Immediately post-procedure (Up to 1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.