Effectiveness of Generic Versus Reference Cetrorelix Acetate for Ovarian Stimulation Using a Gonadotropin-releasing Hormone(GnRH)Antagonist Protocol in Women Undergoing IVF
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06023602 |
Recruitment Status :
Not yet recruiting
First Posted : September 5, 2023
Last Update Posted : November 15, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infertility | Drug: Generic cetrorelix acetate Drug: Reference cetrorelix acetate | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1338 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Estimated Study Start Date : | December 1, 2023 |
Estimated Primary Completion Date : | December 1, 2024 |
Estimated Study Completion Date : | December 1, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Generic cetrorelix acetate |
Drug: Generic cetrorelix acetate
Generic cetrorelix acetate (0.25 mg SC) |
Active Comparator: Reference cetrorelix acetate |
Drug: Reference cetrorelix acetate
reference cetrorelix acetate (0.25 mg SC) |
- 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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 42 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
-
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
Exclusion Criteria:
-
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06023602
Contact: HE CAI, Doctor | +8613581613908 | caihe@bjmu.edu.cn | |
Contact: Juanzi Shi, Doctor | +18602991568 | shijuanziart@126.com |
China, None Selected | |
He Cai | |
Xi'an, None Selected, China | |
Contact: He Cai caihe@bjmu.edu.cn |
Responsible Party: | He Cai, Principal Investigator, Northwest Women's and Children's Hospital, Xi'an, Shaanxi |
ClinicalTrials.gov Identifier: | NCT06023602 |
Other Study ID Numbers: |
2023-038 |
First Posted: | September 5, 2023 Key Record Dates |
Last Update Posted: | November 15, 2023 |
Last Verified: | November 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Infertility Genital Diseases Urogenital Diseases Cetrorelix Fertility Agents, Female |
Fertility Agents Reproductive Control Agents Physiological Effects of Drugs Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |