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

Short name ANGAS

NCTNCT06091436Other idGenSci094-301

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Overview

Status: Completed
Phase: Phase 3
Enrollment: 176 participants (actual)
Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
Design: Randomized · Quadruple masking
Countries: 1 country
China
Start: 24 Mar 2023
Primary completion: 25 Dec 2023
Completion: 29 Jan 2024
First posted: 19 Oct 2023
Last update posted: 3 Dec 2024
Conditions: Infertility

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202320242025

Ph 3
ANGAS
NCT06091436
24 Mar 2023 to 29 Jan 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

GenSci094Drug
Placebo RecFSH / follitropin alfaDrug
Biological: RecFSH / Follitropin alfa (Days 1 to 7)Biological
Placebo GenSci094Drug
RecFSH / Follitropin alfa (Days 8 to hCG)Biological
GanirelixDrug
hCGBiological
ProgesteroneDrug

Arms2

Experimental
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.
Active comparator
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Mean Number of Oocytes Retrieved
Time frame · Approximately Day 10-14

Secondary outcomes(6)

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 20 Years up to 39 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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