To Investigate Efficacy and Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference
NCT ID: NCT06091436
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
176 participants
INTERVENTIONAL
2023-03-24
2024-01-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
GenSci094
Participants received a single subcutaneous (SC) injection of 150 µg or 100µg GenSci094 on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 150 IU or225IU recFSH up to the day of hCG. Daily SC injections of Ganirelix were administered from Stimulation Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles \>= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started and continued for up to 6 weeks or menses.
GenSci094
On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg or 100μg (0.5 mL) GenSci094 was administered in the abdominal wall.
Placebo RecFSH / follitropin alfa
powder-injection, but without the active ingedient, SC injection . Daily SC injections were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
RecFSH / Follitropin alfa (Days 8 to hCG)
From Stimulation Day 8 onwards a daily SC dose 75IU～300 IU recFSH was administered up to and including the Day of hCG.
Ganirelix
On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG
hCG
When 3 follicles \>= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP
Progesterone
On the day of OPU, luteal phase support was started by administering micronized progesterone of at least 400 mg/day vaginally, and 40mg/d oral, which continued for at least 6 weeks, or up to menses.
recFSH
Participants received a single SC injection of placebo GenSci094 on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 150 IU or 225IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; at which time a single dose of hCG was administered when 3 follicles \>= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
Biological: RecFSH / Follitropin alfa (Days 1 to 7)
Daily SC injections with 150IU or 225IU recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
Placebo GenSci094
Pre-filled syringe containing an identical solution when compared to GenSci094. On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection was administered in the abdominal wall.
RecFSH / Follitropin alfa (Days 8 to hCG)
From Stimulation Day 8 onwards a daily SC dose 75IU～300 IU recFSH was administered up to and including the Day of hCG.
Ganirelix
On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG
hCG
When 3 follicles \>= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP
Progesterone
On the day of OPU, luteal phase support was started by administering micronized progesterone of at least 400 mg/day vaginally, and 40mg/d oral, which continued for at least 6 weeks, or up to menses.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GenSci094
On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg or 100μg (0.5 mL) GenSci094 was administered in the abdominal wall.
Placebo RecFSH / follitropin alfa
powder-injection, but without the active ingedient, SC injection . Daily SC injections were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
Biological: RecFSH / Follitropin alfa (Days 1 to 7)
Daily SC injections with 150IU or 225IU recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
Placebo GenSci094
Pre-filled syringe containing an identical solution when compared to GenSci094. On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection was administered in the abdominal wall.
RecFSH / Follitropin alfa (Days 8 to hCG)
From Stimulation Day 8 onwards a daily SC dose 75IU～300 IU recFSH was administered up to and including the Day of hCG.
Ganirelix
On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG
hCG
When 3 follicles \>= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP
Progesterone
On the day of OPU, luteal phase support was started by administering micronized progesterone of at least 400 mg/day vaginally, and 40mg/d oral, which continued for at least 6 weeks, or up to menses.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* \>=20 and \<40 years of age at the time of signing informed consent;
* Body weight \>=50 kg and body mass index (BMI) \>=18 and \<=28 kg/m\^2;
* AMH\<4.0 and\>=1.1μg/L FSH\<10 IU/L
* Willing and able to sign informed consent.
Exclusion Criteria
* History of/or current polycystic ovary syndrome (PCOS);
* More than 20 basal antral follicles \<11 mm (both ovaries combined) as measured on ultrasound scan (USS) in the early follicular phase (menstrual cycle day 2-4);
* Presence of unilateral or bilateral hydrosalphinx (visible on USS);
* Presence of any clinically relevant pathology affecting the uterine cavity or fibroids \>4 cm;
* More than three unsuccessful IVF cycles since the last established ongoing pregnancy (if applicable);
* History of non- or low ovarian response to FSH/ human menopausal gonadotropin (hMG) treatment;
* History of recurrent miscarriage (3 or more, even when unexplained);
* Any clinically relevant abnormal laboratory value based on a sample taken during the screening phase;
* Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts);
* Recent history of/or current epilepsy, human immunodeficiency virus (HIV) infection, diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary disease;
* Use of hormonal preparations within 1 month prior to randomization;
* Hypersensitivity to any of the concomitant medication prescribed as part of the treatment regimen in this protocol;
* Administration of investigational drugs within three months prior to signing informed consent.
20 Years
39 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
xiaoyan liang, doctor
Role: STUDY_CHAIR
The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GenSci094-301
Identifier Type: -
Identifier Source: org_study_id