To Investigate Efficacy and Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (ANGAS)

GeneScience Pharmaceuticals (GenSci)

Status and phase: Completed; Phase 3

Conditions: Infertility

Treatments: Drug: GenSci094; Drug: Placebo GenSci094; Biological: hCG; Biological: Biological: RecFSH / Follitropin alfa (Days 1 to 7); Drug: Progesterone; Biological: RecFSH / Follitropin alfa (Days 8 to hCG); Drug: Ganirelix; Drug: Placebo RecFSH / follitropin alfa

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06091436

GenSci094-301

Details and patient eligibility

About

To investigate the efficacy and safety of a single injection of GenSci094 to induce multi-follicular development for controlled ovarian stimulation using daily recombinant FSH (recFSH) as a reference. The primary hypothesis is that a single injection of GenSci094 is non-inferior to daily treatment with recFSH in initiating multi-follicular growth.

Enrollment: 176 patients

Sex: Female

Ages: 20 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females of couples with an indication for Controlled Ovarian Stimulation (COS) and in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI);
• >=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 ovarian hyper-response or ovarian hyperstimulation syndrome (OHSS);
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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176 participants in 2 patient groups

GenSci094

Experimental group

Description:

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.

Treatment:

Drug: Placebo RecFSH / follitropin alfa

Drug: Ganirelix

Biological: RecFSH / Follitropin alfa (Days 8 to hCG)

Drug: Progesterone

Biological: hCG

Drug: GenSci094

recFSH

Active Comparator group

Description:

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.

Treatment:

Drug: Ganirelix

Biological: RecFSH / Follitropin alfa (Days 8 to hCG)

Drug: Progesterone

Biological: Biological: RecFSH / Follitropin alfa (Days 1 to 7)

Biological: hCG

Drug: Placebo GenSci094