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

NCT06091436 | Completed Phase 3 DMC

• 1 other identifier: GenSci094-301
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Mean Number of Oocytes Retrieved

  Approximately Day 10-14

Secondary Outcomes (6)

• Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate)

  Assessed at least 10 weeks after embryo transfer

• Percentage of Fertilized Oocytes (Fertilization Rate)

  Up to 18 hours after start of fertilization

• Number of Embryos Obtained on Day 3 Categorized by Quality

  Post fertilization Day 3

• Percentage of Gestational Sacs (Implantation Rate)

  Up to 6 weeks after embryo transfer

• Percentage of Participants With a Biochemical Pregnancy Per Embryo Transfer

  Two weeks after embryo transfe

Study Arms (2)

GenSci094

EXPERIMENTAL

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.

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

recFSH

ACTIVE COMPARATOR

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

Interventions

GenSci094 DRUG

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.

GenSci094

Placebo RecFSH / follitropin alfa DRUG

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.

GenSci094

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

Daily SC injections with 150IU or 225IU recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.

recFSH

Placebo GenSci094 DRUG

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

RecFSH / Follitropin alfa (Days 8 to hCG) BIOLOGICAL

From Stimulation Day 8 onwards a daily SC dose 75IU～300 IU recFSH was administered up to and including the Day of hCG.

GenSci094; recFSH

Ganirelix DRUG

On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG

GenSci094; recFSH

hCG BIOLOGICAL

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

GenSci094; recFSH

Progesterone DRUG

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.

GenSci094; recFSH

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead
• Sixth Affiliated Hospital, Sun Yat-sen University: collaborator

Study Sites (1)

The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital

Guangzhou, Guangdong, 510610, China

Location

MeSH Terms

Conditions

Infertility

Interventions

follitropin alfa; ganirelix; Progesterone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• xiaoyan liang, doctor

  The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: October 19, 2023
• Study Start: March 24, 2023
• Primary Completion: December 25, 2023
• Study Completion: January 29, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-12

Locations

CN (1)