InfertilityNCT06023602
Effectiveness of Generic Versus Reference Cetrorelix Acetate for Ovarian Stimulation Using a Gonadotropin-releasing Hormone（GnRH）Antagonist Protocol in Women Undergoing IVF
A study testing Generic cetrorelix acetate and Reference cetrorelix acetate in people with Infertility, run by Northwest Women's and Children's Hospital, Xi'an, Shaanxi at 1 site in China.
Trial summary
The goal of this clinical trial is to compare the clinical outcomes using different cetrorelix acetate in the context of a GnRH antagonist protocol for ovarian stimulation in women undergoing IVF or intracytoplasmic sperm injection(ICSI) treatment.The main question it aims to answer is whether the generic cetrorelix… Read more about this study
- Who is it for?
- Ages 20 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Generic cetrorelix acetate and Reference cetrorelix acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,338 participants
- Where
- 1 siteChina
- Study dates
- 27 Feb 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Infertile couples plan to undergo IVF / ICSI pregnancy treatment into screening procedures and clinical study
- All subjects should sign the informed consent form
- Infertile women <43 years old
- With flexible GnRH antagonist
Who cannot join
- Subjects could not enter the study if they meet any one of the following criteria
- Preimplantation Genetic Testing (PGT)
- Untreated hydrosalpinges, moderate or severe endometriosis, recurrent spontaneous miscarriage, endometrial pathology, uterine malformations, etc
- Endocrine diseases (such as hyperthyroidism, hyperprolactinemia, etc.) or other systemic disease and other systemic diseases (such as hypertension, diabetes, etc.)．
- Other factors were considered inappropriate by the investigator to participate, or assisted reproductive technology/pregnancy contraindications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
He Cai
Xi'an, None Selected
He Cai, caihe@bjmu.edu.cn
About this study
Official title: Effectiveness of Generic Cetrorelix Acetate Versus Reference Cetrorelix Acetate for Ovarian Stimulation Using a GnRH Antagonist Protocol in Women Undergoing IVF: A Multicenter Non-inferiority, Randomised Controlled Trial
The goal of this clinical trial is to compare the clinical outcomes using different cetrorelix acetate in the context of a GnRH antagonist protocol for ovarian stimulation in women undergoing IVF or intracytoplasmic sperm injection(ICSI) treatment.The main question it aims to answer is whether the generic cetrorelix acetate is non-inferior to the reference product in the GnRH antagonist based protocol for women undergoing IVF. Ovarian stimulation was achieved by several types of follicle-stimulating hormone(FSH) or by FSH combined with luteinizing hormone activity. Daily dose of generic cetrorelix acetate (0.25 mg SC) or original cetrorelix acetate (0.25 mg SC) will be administered when the lead follicle was 14 mm. When more than two follicles reached 17 mm, oocyte maturation was triggered with 250 mcg of recombinant human chorionic gonadotropin.
- Conditions
- Infertility
- Being tested
- Generic cetrorelix acetate, Reference cetrorelix acetate
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generic cetrorelix acetateDrug
Generic cetrorelix acetate (0.25 mg SC)
Reference cetrorelix acetateDrug
reference cetrorelix acetate (0.25 mg SC)
| Study group | Role | What they receive |
|---|---|---|
| Generic cetrorelix acetate | Experimental | Not described Receives: Drug: Generic cetrorelix acetate |
| Reference cetrorelix acetate | Active comparator | Not described Receives: Drug: Reference cetrorelix acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative live birth rate
For the first live birth (gestation≥ 24 weeks) in one in vitro fertilization/intracytoplasmic sperm injection egg retrieval cycle (fresh and frozen-thawed embryo transfer cycle)
Measured: Through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start27 Feb 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwest Women's and Children's Hospital, Xi'an, Shaanxi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He Cai, Northwest Women's and Children's Hospital, Xi'an, Shaanxi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023602
- Sponsor's protocol ID
- 2023-038
- Status last verified
- Sep 2025
- First submitted
- 18 Aug 2023
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dovey S, McIntyre K, Jacobson D, Catov J, Wakim A. Is a premature rise in luteinizing hormone in the absence of increased progesterone levels detrimental to pregnancy outcome in GnRH antagonist in vitro fertilization cycles. Fertil Steril. 2011 Sep;96(3):585-9. doi: 10.1016/j.fertnstert.2011.06.042. Epub 2011 Jul 20.
PubMed 21774931Liu X, Wen W, Wang T, Tian L, Li N, Sun T, Wang T, Zhou H, Zhang N, Qu P, Mol BW, Li W, Shi J. Increased versus standard gonadotrophin dosing in predicted poor responders of IVF: an open-label randomized controlled trial. Hum Reprod. 2022 Jul 30;37(8):1806-1815. doi: 10.1093/humrep/deac113.
PubMed 35595197
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Generic Cetrorelix Acetate Versus Reference Cetrorelix Acetate for Ovarian Stimulation Using a GnRH Antagonist Protocol in Women Undergoing IVF: A Multicenter Non-inferiority, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06023602
- Acronym / sponsor ID
- 2023-038
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,338 participants (estimated)
- Lead sponsor
- Northwest Women's and Children's Hospital, Xi'an, ShaanxiUniversity, hospital or other
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 5 Sep 2023 (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 goal of this clinical trial is to compare the clinical outcomes using different cetrorelix acetate in the context of a GnRH antagonist protocol for ovarian stimulation in women undergoing IVF or intracytoplasmic sperm injection(ICSI) treatment.The main question it aims to answer is whether the generic cetrorelix acetate is non-inferior to the reference product in the GnRH antagonist based protocol for women undergoing IVF. Ovarian stimulation was achieved by several types of follicle-stimulating hormone(FSH) or by FSH combined with luteinizing hormone activity. Daily dose of generic cetrorelix acetate (0.25 mg SC) or original cetrorelix acetate (0.25 mg SC) will be administered when the lead follicle was 14 mm. When more than two follicles reached 17 mm, oocyte maturation was triggered with 250 mcg of recombinant human chorionic gonadotropin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Generic cetrorelix acetate | Experimental | Drug: Generic cetrorelix acetate |
| Reference cetrorelix acetate | Active comparator | Drug: Reference cetrorelix acetate |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Infertile couples plan to undergo IVF / ICSI pregnancy treatment into screening procedures and clinical study
Key exclusion criteria (5 listed)
- Subjects could not enter the study if they meet any one of the following criteria
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 |
|---|---|---|
| Generic cetrorelix acetateGeneric cetrorelix acetate (0.25 mg SC) | Drug | Generic cetrorelix acetate |
| Reference cetrorelix acetatereference cetrorelix acetate (0.25 mg SC) | Drug | Reference cetrorelix acetate |
Primary outcome
Cumulative live birth rate
Time frame: Through study completion, an average of 18 months
For the first live birth (gestation≥ 24 weeks) in one in vitro fertilization/intracytoplasmic sperm injection egg retrieval cycle (fresh and frozen-thawed embryo transfer cycle)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Results publication: PubMed 21774931Dovey S, McIntyre K, Jacobson D, Catov J, Wakim A. Is a premature rise in luteinizing hormone in the absence of increased progesterone levels detrimental to pregnancy outcome in GnRH antagonist in vitro fertilization cycles. Fertil Steril. 2011 Sep;96(3):585-9. doi: 10.1016/j.fertnstert.2011.06.042. Epub 2011 Jul 20.
- Results publication: PubMed 35595197Liu X, Wen W, Wang T, Tian L, Li N, Sun T, Wang T, Zhou H, Zhang N, Qu P, Mol BW, Li W, Shi J. Increased versus standard gonadotrophin dosing in predicted poor responders of IVF: an open-label randomized controlled trial. Hum Reprod. 2022 Jul 30;37(8):1806-1815. doi: 10.1093/humrep/deac113.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Generic cetrorelix acetate and Reference cetrorelix acetate in people with Infertility, run by Northwest Women's and Children's Hospital, Xi'an, Shaanxi at 1 site in China.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 19 Sep 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HE CAI, Doctor (+8613581613908, caihe@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative live birth rate (time frame: Through study completion, an average of 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06023602, which also lists 2 linked publications.
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 19 Sep 2025.