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InfertilityPhase 3ANGASNCT06091436

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

A Phase 3 study testing GenSci094, Biological: RecFSH / Follitropin alfa (Days 1 to 7) and RecFSH / Follitropin alfa (Days 8 to hCG) in people with Infertility, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 39 years, women only
Conditions the study is for
Infertility
What is being tested?
GenSci094, Biological: RecFSH / Follitropin alfa (Days 1 to 7) and RecFSH / Follitropin alfa (Days 8 to hCG)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
176 participants
Where
1 siteChina
Study dates
24 Mar 2023to 29 Jan 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 39 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
Show all 14Show fewer
  • 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 locations and contacts

1 site in 1 country.

China1 site

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

    Guangzhou, Guangdong, 510610

Other trials in China

About this study

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

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
Being tested
GenSci094, Placebo RecFSH / follitropin alfa, Biological: RecFSH / Follitropin alfa (Days 1 to 7), Placebo GenSci094, RecFSH / Follitropin alfa (Days 8 to hCG)
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GenSci094Drug

    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 alfaDrug

    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: 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.

  • Placebo GenSci094Drug

    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 / 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.

  • GanirelixDrug

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

  • hCGBiological

    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

  • ProgesteroneDrug

    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.

Study groups in NCT06091436
Study groupRoleWhat they receive
GenSci094ExperimentalParticipants 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.
Receives: Drug: GenSci094; Drug: Placebo RecFSH / follitropin alfa; Biological: RecFSH / Follitropin alfa (Days 8 to hCG); Drug: Ganirelix; Biological: hCG; Drug: Progesterone
recFSHActive comparatorParticipants 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Number of Oocytes Retrieved

    Measured: Approximately Day 10-14

Secondary outcomes (6)

  1. Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate)

    Measured: Assessed at least 10 weeks after embryo transfer

  2. Percentage of Fertilized Oocytes (Fertilization Rate)

    Measured: Up to 18 hours after start of fertilization

  3. Number of Embryos Obtained on Day 3 Categorized by Quality

    Measured: Post fertilization Day 3

  4. Percentage of Gestational Sacs (Implantation Rate)

    Measured: Up to 6 weeks after embryo transfer

  5. Percentage of Participants With a Biochemical Pregnancy Per Embryo Transfer

    Measured: Two weeks after embryo transfe

  6. Percentage of Participants With a early miscarriage（early miscarriage rate）Per Clinical Pregnancy

    Measured: Up to 12 weeks after embryo transfer

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2023
  2. Study start24 Mar 2023
  3. Primary completion25 Dec 2023
  4. Study completion29 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
176 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06091436
Sponsor's protocol ID
GenSci094-301
Acronym
ANGAS
Status last verified
Dec 2024
First submitted
8 Aug 2023
Last updated
3 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GenSci094, Biological: RecFSH / Follitropin alfa (Days 1 to 7) and RecFSH / Follitropin alfa (Days 8 to hCG) in people with Infertility, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Number of Oocytes Retrieved (time frame: Approximately Day 10-14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06091436.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.

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