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

Infertility Clinical Trial

— ANGAS  

Official title:

A Multicenter, Double-blind, Non-inferiority, Phase 3 RCT Comparing GenSci094 and Recombinant FSH During the First Seven Days of Ovarian Stimulation in Chinese ART Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06091436
• Other study ID #: GenSci094-301
• Status: Recruiting
• Phase: Phase 3
• Start date: March 24, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: July 2023
• Source: Changchun GeneScience Pharmaceutical Co., Ltd.
• Contact: shuqin jiang
• Phone: 18036617122
• Email: jiangshuqin[@]gensci-china.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: August 31, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• 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:
• 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.

Drug:
• 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.

Biological:
• 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.

Drug:
• 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

Biological:
• 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

Drug:
• 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.

Locations

Country	Name	City	State
China	The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Changchun GeneScience Pharmaceutical Co., Ltd.	Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Number of Oocytes Retrieved		Approximately Day 10-14
Secondary	Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate)		Assessed at least 10 weeks after embryo transfer
Secondary	Percentage of Fertilized Oocytes (Fertilization Rate)		Up to 18 hours after start of fertilization
Secondary	Number of Embryos Obtained on Day 3 Categorized by Quality		Post fertilization Day 3
Secondary	Percentage of Gestational Sacs (Implantation Rate)		Up to 6 weeks after embryo transfer
Secondary	Percentage of Participants With a Biochemical Pregnancy Per Embryo Transfer		Two weeks after embryo transfe
Secondary	Percentage of Participants With a early miscarriage(early miscarriage rate)Per Clinical Pregnancy		Up to 12 weeks after embryo transfer