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To Compare the Efficacy and Safety of Oral SHR 7280 Tablets With Ganirelix Acetate Injection in Infertile Female Subjects

Primary Purpose

Infertile Female Subjects Undergoing Controlled Ovarian Hyperstimulation to Suppress Premature LH Surge and Prevent Early Ovulation

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
SHR7280;Ganirelix Acetate Injection simulant
SHR7280 simulant; Ganirelix Acetate Injection
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertile Female Subjects Undergoing Controlled Ovarian Hyperstimulation to Suppress Premature LH Surge and Prevent Early Ovulation

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Married infertile female subjects aged 20 to 39 years with indications for in vitro fertilization-embryo transfer (IVF-ET) or intracytoplasmic sperm injection (ICSI); Body mass index (BMI) 18 ~ 28kg/m2 (both exclusive) and weight 45Kg ~ 75Kg (both inclusive); Regular menstrual cycle (24 ~ 35 days, both inclusive) for the last 3 months prior to screening; Anticipated normal ovarian response; Willingness of the subject to undergo fresh cycle transfer with one or two embryos at a time in the first IVF-ET cycle; Normal cervical cytology results (TCT) or with limited clinically significance within 1 year prior to screening or on the screening visit; or subjects with atypical squamous cells of undetermined significance (ASC-US) of TCT tested negative for high-risk types of human papillomavirus (HPV); Informed consent of subjects and their spouses; Exclusion Criteria: Prior to screening, individuals underwent three or more IVF/ICSI-ET COH cycles without achieving clinical pregnancy; Previous IVF/ ICSI failure due to sperm/fertilization problems and no improvement in related medical condition; Subjects with more than 2 times of spontaneous abortion; Subjects at high risk of OHSS, judged by the investigator according to the Golan classification (e.g., those with moderate to severe OHSS during previous COH cycles, polycystic ovary syndrome (PCOS), or with previous cancelled COH cycles due to OHSS); Subjects with decreased ovarian reserve; TSH test result above or equal to 2.5 mIU/L for subjects with prior hypothyroidism or subclinical hypothyroidism on screening visit; Any pregnancy that occurred within 3 months prior to screening visit; Unexplained abnormal vaginal bleeding; Infectious disease screening indicates any of the following: positive for HIV antibodies, positive for syphilis spirochete antibodies; positive for Hepatitis C virus (HCV) antibodies and positive HCV-RNA test; positive for Hepatitis B surface antigen (HBsAg) and HBV-DNA ≥ 1×103 kIU/L (or IU/mL); Use of fertility regulators within one month before ovarian stimulation, such as clomiphene citrate, letrozole, gonadotropins (Gn), metformin, hormonal drugs (including oral contraceptives, estrogens, progestogens, etc.). Past medical history or gynecological ultrasound indicates clinically significant conditions; ALT and AST levels at the screening visit or the start of ovarian stimulation were more than twice the upper limit of normal; Positive serum β-hCG test results on the screening visit or the start day of ovarian stimulation; Blood or blood component donation within one month before screening, or a blood loss equivalent to at least 200 mL, or a blood transfusion within two months; Severe infection, severe trauma, or major surgery within six months before screening; Any disease or symptom that can affect systemic function and may affect the absorption, accumulation, metabolism, or excretion of the test drug (e.g., chronic intestinal diseases, Crohn's disease, ulcerative colitis). Major systemic diseases, endocrine or metabolic abnormalities; Thromboembolic diseases or a history of thromboembolic diseases; The subject or her spouse requires oocyte or sperm donation, or either or both of them carry a chromosomal abnormality deemed clinically significant by the researcher, or suffer from a known monogenic hereditary disease or a severe disease with genetic susceptibility requiring pre-implantation genetic testing (PGT); Smoking (more than 5 cigarettes or equivalent tobacco daily) or alcohol abuse (drinking ≥14 units of alcohol weekly: 1 unit = 360 mL beer, or 25 mL of 40% or higher spirits, or 1 glass of wine, 180 mL) within three months before screening; History of drug abuse or drug dependence; Allergic constitution or allergy to two or more foods or drugs, including a known allergy to any component of the test drug or non-test drug; contraindication or allergy to GnRH agonists or GnRH antagonists, recombinant or urinary FSH, hCG, progesterone drugs; Participation in any drug or medical device clinical trial within three months before screening, or still in the follow-up period of a clinical study before screening, or within the 5 half-lives of the test drug (whichever is longer); Malignant tumor or history of malignant tumor (except basal cell or squamous cell skin cancer, in situ cancer), or a high risk of malignant tumor onset/recurrence; Known history of severe mental illness, or inability to understand the purpose, methods, etc., of this clinical trial, or non-compliance with research procedures; Any other reasons deemed by the researcher as unsuitable for participation in this study.

Sites / Locations

  • Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Number of oocyte retrieved per COH cycle
number of oocytes obtained after one COH cycle;
Inhibition rate of premature LH surge
premature LH surge is defined as: LH ≥ 10 IU/L and progesterone P ≥ 1 ng/mL (3.18 nmol/L);

Secondary Outcome Measures

2PN rate
number of 2 pronuclei(2PN) oocytes/ number of oocytes retrieved or number of MII oocytes×100%;
High quality embryo rate
number of high-quality embryos/ cleavage number×100%;
Chemical pregnancy rate
number of pregnancy cycles/ number of transplantation cycles×100%;
Clinical pregnancy rate
number of clinical pregnancy cycles/ number of transplantation cycles×100%;
Persistent pregnancy rate
number of clinical pregnancy cycles/ number of transplantation cycles×100%;
Adverse drug events

Full Information

First Posted
August 9, 2023
Last Updated
October 24, 2023
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05994378
Brief Title
To Compare the Efficacy and Safety of Oral SHR 7280 Tablets With Ganirelix Acetate Injection in Infertile Female Subjects
Official Title
To Compare the Efficacy and Safety of Oral SHR7280 Tablets With Ganirelix Acetate Injection in Female Subjects With Infertility Receiving Controlled Ovarian Hyperstimulation Therapy: A Multi-center, Randomized, Parallel-Group, Double-Blind, Dual-Simulation, Non-Inferiority Phase III Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 29, 2023 (Actual)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study is a multi-center, randomized, double-blind, positive drug-controlled, non-inferiority Phase III clinical trial. The study will enroll approximately 316 infertile female subjects undergoing controlled ovarian hyperstimulation (COH) for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertile Female Subjects Undergoing Controlled Ovarian Hyperstimulation to Suppress Premature LH Surge and Prevent Early Ovulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
316 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
SHR7280;Ganirelix Acetate Injection simulant
Intervention Description
SHR7280 200mg Q12h and Ganirelix Acetate Injection simulant 0.5mL qd;
Intervention Type
Drug
Intervention Name(s)
SHR7280 simulant; Ganirelix Acetate Injection
Intervention Description
SHR7280 simulant 200mg Q12h and Ganirelix Acetate Injection 0.5mL:0.25mg qd;
Primary Outcome Measure Information:
Title
Number of oocyte retrieved per COH cycle
Description
number of oocytes obtained after one COH cycle;
Time Frame
On oocyte retrieval 1 day
Title
Inhibition rate of premature LH surge
Description
premature LH surge is defined as: LH ≥ 10 IU/L and progesterone P ≥ 1 ng/mL (3.18 nmol/L);
Time Frame
the hCG injection 1 day
Secondary Outcome Measure Information:
Title
2PN rate
Description
number of 2 pronuclei(2PN) oocytes/ number of oocytes retrieved or number of MII oocytes×100%;
Time Frame
16-18 hours (h) after fertilization
Title
High quality embryo rate
Description
number of high-quality embryos/ cleavage number×100%;
Time Frame
3 days after fertilization
Title
Chemical pregnancy rate
Description
number of pregnancy cycles/ number of transplantation cycles×100%;
Time Frame
on chemical pregnancy test 1 day
Title
Clinical pregnancy rate
Description
number of clinical pregnancy cycles/ number of transplantation cycles×100%;
Time Frame
on clinical pregnancy test 1 day
Title
Persistent pregnancy rate
Description
number of clinical pregnancy cycles/ number of transplantation cycles×100%;
Time Frame
on persistent pregnancy test 1 day
Title
Adverse drug events
Time Frame
Day 1 to persistent pregnancy test day/ or End-of-trial visit 1 day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Married infertile female subjects aged 20 to 39 years with indications for in vitro fertilization-embryo transfer (IVF-ET) or intracytoplasmic sperm injection (ICSI); Body mass index (BMI) 18 ~ 28kg/m2 (both exclusive) and weight 45Kg ~ 75Kg (both inclusive); Regular menstrual cycle (24 ~ 35 days, both inclusive) for the last 3 months prior to screening; Anticipated normal ovarian response; Willingness of the subject to undergo fresh cycle transfer with one or two embryos at a time in the first IVF-ET cycle; Normal cervical cytology results (TCT) or with limited clinically significance within 1 year prior to screening or on the screening visit; or subjects with atypical squamous cells of undetermined significance (ASC-US) of TCT tested negative for high-risk types of human papillomavirus (HPV); Informed consent of subjects and their spouses; Exclusion Criteria: Prior to screening, individuals underwent three or more IVF/ICSI-ET COH cycles without achieving clinical pregnancy; Previous IVF/ ICSI failure due to sperm/fertilization problems and no improvement in related medical condition; Subjects with more than 2 times of spontaneous abortion; Subjects at high risk of OHSS, judged by the investigator according to the Golan classification (e.g., those with moderate to severe OHSS during previous COH cycles, polycystic ovary syndrome (PCOS), or with previous cancelled COH cycles due to OHSS); Subjects with decreased ovarian reserve; TSH test result above or equal to 2.5 mIU/L for subjects with prior hypothyroidism or subclinical hypothyroidism on screening visit; Any pregnancy that occurred within 3 months prior to screening visit; Unexplained abnormal vaginal bleeding; Infectious disease screening indicates any of the following: positive for HIV antibodies, positive for syphilis spirochete antibodies; positive for Hepatitis C virus (HCV) antibodies and positive HCV-RNA test; positive for Hepatitis B surface antigen (HBsAg) and HBV-DNA ≥ 1×103 kIU/L (or IU/mL); Use of fertility regulators within one month before ovarian stimulation, such as clomiphene citrate, letrozole, gonadotropins (Gn), metformin, hormonal drugs (including oral contraceptives, estrogens, progestogens, etc.). Past medical history or gynecological ultrasound indicates clinically significant conditions; ALT and AST levels at the screening visit or the start of ovarian stimulation were more than twice the upper limit of normal; Positive serum β-hCG test results on the screening visit or the start day of ovarian stimulation; Blood or blood component donation within one month before screening, or a blood loss equivalent to at least 200 mL, or a blood transfusion within two months; Severe infection, severe trauma, or major surgery within six months before screening; Any disease or symptom that can affect systemic function and may affect the absorption, accumulation, metabolism, or excretion of the test drug (e.g., chronic intestinal diseases, Crohn's disease, ulcerative colitis). Major systemic diseases, endocrine or metabolic abnormalities; Thromboembolic diseases or a history of thromboembolic diseases; The subject or her spouse requires oocyte or sperm donation, or either or both of them carry a chromosomal abnormality deemed clinically significant by the researcher, or suffer from a known monogenic hereditary disease or a severe disease with genetic susceptibility requiring pre-implantation genetic testing (PGT); Smoking (more than 5 cigarettes or equivalent tobacco daily) or alcohol abuse (drinking ≥14 units of alcohol weekly: 1 unit = 360 mL beer, or 25 mL of 40% or higher spirits, or 1 glass of wine, 180 mL) within three months before screening; History of drug abuse or drug dependence; Allergic constitution or allergy to two or more foods or drugs, including a known allergy to any component of the test drug or non-test drug; contraindication or allergy to GnRH agonists or GnRH antagonists, recombinant or urinary FSH, hCG, progesterone drugs; Participation in any drug or medical device clinical trial within three months before screening, or still in the follow-up period of a clinical study before screening, or within the 5 half-lives of the test drug (whichever is longer); Malignant tumor or history of malignant tumor (except basal cell or squamous cell skin cancer, in situ cancer), or a high risk of malignant tumor onset/recurrence; Known history of severe mental illness, or inability to understand the purpose, methods, etc., of this clinical trial, or non-compliance with research procedures; Any other reasons deemed by the researcher as unsuitable for participation in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zeli Li
Phone
+86 0518-82342973
Email
zeli.li.zl13@hengrui.com
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Qiao

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

To Compare the Efficacy and Safety of Oral SHR 7280 Tablets With Ganirelix Acetate Injection in Infertile Female Subjects

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