CTRI/2025/07/090950尚未招募3 期
A Randomized, Assessor-Blind, Active-Controlled, Parallel Group, Two-Arm, Phase-3 Study To Compare Safety, Efficacy and Immunogenicity of R-hFSH (Recombinant Human Follicle Stimulating Hormone (Follitropin Alfa) Injection of Intas Pharmaceuticals Ltd., With Recombinant Human Follicle Stimulating Hormone (r-hFSH) Follitropin Alfa (Gonal-F) of Merk Serono Ltd. in Adult Females Undergoing Assisted Reproductive Technology.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 320
- 试验地点
- 9
- 主要终点
- equivalence of r-hFSH-test
研究概览
简要总结
To establish the therapeutic equivalence and compare the pharmacodynamic effects and to characterize additional efficacy parameters of r hFSH-test compared with r hFSH reference in the fresh cycle in women undergoing controlled ovarian stimulation for ART.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 38.00 Year(s)（—）
- 性别
- Female
入选标准
- •Must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study as described in Appendix 10.1.3 and in this protocol and is willing to participate in the study. 2) Female with menstrual cycle of 21-35 days (maximum up to 42 days) presumed to be ovulatory, who desires pregnancy and is eligible for ART. 3) Age of 21 to 38 at the time of signing the informed consent. 4) BMI within 18-35 kg per m2 (inclusive) at screening. 5) Participants with minimum of one menstrual cycle without treatment with fertility modifiers (E.g., Clomiphene Citrate; Participants with these drug use can be considered after appropriate washout period is completed before screening) as determined by the investigator at the time of signing the informed consent. 6) Documented history of infertility.
- •means unable to conceive for at least 12 months in less than 35 years or for at least 6 months if receiving donor sperm OR greater than 35 years with following laboratory parameters to be assessed: i) A Day 2 or Day 3 (early follicular phase) serum FSH level between 1 and 12 IU per L (or 1 and 12 mIU per mL) (both inclusive), the results of which should be obtained within 3 months prior to randomization or at randomization. ii) Antral follicle count greater than 5 follicle and antral mullerian hormone level (AMH) greater than 0.5 ng per mL (or greater than 3.57 pmol per L) at screening or within 3 months prior to randomization as determined by investigator. 7) Ultrasonographic examination (transvaginal and or abdominal) documenting presence and adequate visualization of both ovaries and adnexa, without evidence of significant abnormality (e.g., hydrosalpinx) and uterus consistent with expected normal function with no congenital structural abnormality at screening or within 1 year prior to randomization. Note: This also includes females who have been diagnosed with any of the medical conditions related to uterus (e. g, fibroids) but have had them surgically corrected prior to randomization. 8) r-hFSH naïve participant who are appropriate to undergo ART procedure should be first cycle of present series. 9) Negative serum pregnancy test at screening and on the day 1 of stimulation with gonadotropins prior to administration of gonadotropin as well non-lactating for controlled ovarian stimulation. 10) Total testosterone, prolactin, and thyroid stimulating hormone (TSH) within the normal limits for the clinical laboratory or considered not clinically significant by the Investigator at screening or within 12 months prior to screening. Participants are eligible for COS cycle 2 only if all of the following criteria apply: 11) Having undergone the oocyte retrieval procedure, or having had cycle cancellation prior to oocyte retrieval due to poor ovarian response or excessive ovarian response, in the previous COS cycle 1 (fresh cycle). 12) Failure to achieve ongoing pregnancy and early pregnancy loss in the previous COS cycle 1.
排除标准
- •Known allergies, hypersensitivity, or intolerance to any of the study interventions, or components excipients thereof (refer to the SmPC)2, or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study.
- •Documented medical history of uncontrolled, clinically significant intercurrent cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances or any other medical condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocolspecified assessments.
- •Contraindications to the use of investigational intervention per SmPC of Gonal-f.
- •Presence of hepatitis B surface antigen (HbsAg) at screening or within 3 months prior to first dose of investigational intervention.
- •Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of investigational intervention.
- •NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA test is obtained.
- •Has known human immunodeficiency virus (HIV) seropositive status, or positive HIV antibody test at screening.
- •History of abuse of alcohol, nicotine containing products or drugs.
- •History of recurrent miscarriages (3 or more consecutive miscarriages) within 1 year before screening.
- •Documented evidence of Severe ovarian hyperstimulation syndrome (OHSS) in a previous ART treatment.
- •Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to Baseline.
- •Previous IVF or ART failure due to a poor response to gonadotropins (greater than 20 days of gonadotropin stimulation).
- •(Poor response is defined as development of less than or equal to 3 oocytes or history of 2 previous cycle cancellations prior to oocyte retrieval due to poor response).
- •History or current evidence of tumors of ovary, breast, uterus, adrenal glands, pituitary or hypothalamus or any other malignant neoplasm such as endometriosis stage III-IV.
- •Any hormonal treatment within 1 month before the start of the r-hFSH treatment (except stable participants who are on thyroid hormone).
- •Taken any disallowed therapies as noted in Section 6.9, before the planned first dose of investigational intervention.
- •Received an investigational intervention or used an invasive investigational medical device within 30 days or 5 half-lives prior to the first dose of study intervention, whichever is longer.
- •History of randomization in the current study for r-FSH administration.
- •Participant or his partner has a known genetic abnormality and/or require pre-implantation genetic diagnosis which makes participant unfit for the trial as determined by investigator.
- •Participant is ovum donor.
- •Presence of clinically significant polycystic ovarian syndrome (PCOS) according to Rotterdam criteria 20033 as determined by investigator.
- •Known abnormal cervical cytology of clinical significance observed within three years prior to randomization (unless the clinical significance has been resolved).
- •Known currently active pelvic inflammatory disease.
- •Participants meeting any of the criteria listed below will not be eligible for COS cycle 2: 22) Non-compliance to protocol compliance in the previous cycle which impact overall safety of the participants and study assessments.
- •Having undergone any stimulation with gonadotropins since the end-of-trial / end-of-cycle visit in the previous COS cycle
- •Use of any investigational medicinal product since the end-of-trial end-of-cycle visit in the previous COS cycle
- •One or more follicles greater than or equal to 10 mm observed on the transvaginal ultrasound prior to start of dosing on stimulation day 1 (COS cycle 2).
- •Pregnancy (negative urinary pregnancy test must be documented prior to start of dosing on stimulation day 1 of COS cycle 2).
- •Severe OHSS in a previous COS cycle
- •Any clinically relevant change to any of the eligibility criteria in the previous COS cycle
- •In case of late pregnancy loss and thus failure to achieve live birth in the COS cycle 1.
结局指标
主要结局
equivalence of r-hFSH-test
时间窗: Day 2 to 5 up to 20
compared with r-hFSHreference
时间窗: Day 2 to 5 up to 20
in the fresh cycle in
时间窗: Day 2 to 5 up to 20
women undergoing controlled
时间窗: Day 2 to 5 up to 20
ovarian stimulation for ART
时间窗: Day 2 to 5 up to 20
To establish the therapeutic
时间窗: Day 2 to 5 up to 20
次要结局
- To compare the(pharmacodynamic effects and)
- To compare the pregnancy(related outcomes of r-hFSHtest)
研究者
Dr Naman Shah
Lambda Therapeutic Research Ltd
研究点 (9)
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