Current partner codePEPTIDESDE
NCT06091436·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

176

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

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.

DRUG

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.

Timeline

From registration to results.

  1. First posted

    Oct 19, 2023

  2. Study start

    Mar 24, 2023

  3. Primary completion

    Dec 25, 2023

  4. Study completion

    Jan 29, 2024

  5. Results posted

    Not reported

  6. Registry updated

    Dec 3, 2024

Outcomes

What the study measures.

Primary outcomes

Mean Number of Oocytes Retrieved

Time frame · Approximately Day 10-14

Secondary outcomes

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

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
39 Years
Sex
FEMALE
Healthy volunteers
No

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.

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

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

Guangzhou, Guangdong, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Ganirelix.

Related PeptideStat pages

Put the record in context.

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