InfertilityPhase 3NCT05149924
Efficacy and Safety of QL1012 in Women for Assisted Reproductive Treatment
A Phase 3 study testing QL1012 and Gonal-f ® in people with Infertility, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study is conducted to confirm equivalence between QL1012 (a new biosimilar formulation of Recombinant Human Follicle-stimulating Hormone) and Gonal-f® with respect to the number of oocytes retrieved in women for assisted reproductive treatment. 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?
- QL1012 and Gonal-f ®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2018to 17 Oct 2019
- 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
- Signed informed consent
- Aged 20 ~ 39 years(inclusive)
- Body mass index (BMI) between 18~30 kg/m2(inclusive)
- Regular menstrual cycle (25~35 days)
- Basal FSH < 10 IU/L (menstrual cycle day 2~5)
Who cannot join
- History of ≥3 previously completed IVF/ICSI-ET cycles without clinical pregnancy
- History of ≥3 recurrent spontaneous miscarriages
- Patients with high risk of ovarian hyperstimulation syndrome (OHSS)
- Primary ovarian failure or poor responders to ovarian stimulation
- Presence of pregnancy in previous 3 months
- Presence of clinically significant systemic disease, endocrine disease or metabolic abnormalities
- History of malignant tumors of the ovary, breast, uterus, hypothalamus, pituitary gland, etc.;
Trial locations and contacts
1 site in 1 country.
China1 site
The first Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: A Multicenter, Randomized, Single-blind, Active-controlled, Phase III Clinical Study to Compare the Efficacy and Safety of QL1012(Recombinant Human Follicle-stimulating Hormone) and Gonal-f ® in Women Undergoing Controlled Ovarian Hyperstimulation for Assisted Reproductive Treatment
The study is conducted to confirm equivalence between QL1012 (a new biosimilar formulation of Recombinant Human Follicle-stimulating Hormone) and Gonal-f® with respect to the number of oocytes retrieved in women for assisted reproductive treatment.
- Conditions
- Infertility
- Being tested
- QL1012, Gonal-f ®
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1012Drug
Subcutaneous injection,starting dose within 75IU ~ 300IU determined by the age , maximum daily dose 450IU
Gonal-f ®Drug
Subcutaneous injection,starting dose within 75IU ~ 300IU determined by the age , maximum daily dose 450IU
| Study group | Role | What they receive |
|---|---|---|
| QL1012，Recombinant Human Follicle Stimulating Hormone for Injection | Experimental | Not described Receives: Drug: QL1012 |
| Gonal-f ® | Active comparator | Not described Receives: Drug: Gonal-f ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oocytes retrieved
36-38 hours after hCG administration, transvaginal ultrasound-guided aspiration was performed as required, and the number of oocytes was recorded.
Measured: 36-38 hours after hCG administration
Secondary outcomes (9)
Total dose of r-hFSH administered
Measured: From date of randomization up to 16 days
Number of days of r-hFSH stimulation
Measured: From date of randomization up to 16 days
Serum estradiol concentration
Measured: From date of randomization up to 16 days
Endometrial thickness
Measured: From date of randomization up to 16 days
Fertilization Rate of Oocytes
Measured: Day 1 of IVF/ICSI
Rate of high-quality embryos
Measured: 3 days after oocyte retrieval
Implantation rate
Measured: five to six weeks after oocyte retrieval
clinical pregnancy rate
Measured: 35 ± 4 days after embryo transfer
Ongoing pregnancy rate
Measured: Ten 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.
- First posted8 Dec 2021
- Study start31 Oct 2018
- Primary completion17 Oct 2019
- Study completion17 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149924
- Sponsor's protocol ID
- QL1012-002
- Status last verified
- Nov 2021
- First submitted
- 12 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Single-blind, Active-controlled, Phase III Clinical Study to Compare the Efficacy and Safety of QL1012(Recombinant Human Follicle-stimulating Hormone) and Gonal-f ® in Women Undergoing Controlled Ovarian Hyperstimulation for Assisted Reproductive Treatment
- ClinicalTrials.gov ID
- NCT05149924
- Acronym / sponsor ID
- QL1012-002
- Conditions
- Infertility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 17 Oct 2019 (actual)
- Study completion
- 17 Oct 2019 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is conducted to confirm equivalence between QL1012 (a new biosimilar formulation of Recombinant Human Follicle-stimulating Hormone) and Gonal-f® with respect to the number of oocytes retrieved in women for assisted reproductive treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL1012，Recombinant Human Follicle Stimulating Hormone for Injection | Experimental | Drug: QL1012 |
| Gonal-f ® | Active comparator | Drug: Gonal-f ® |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Signed informed consent
- Aged 20 ~ 39 years(inclusive)
- Body mass index (BMI) between 18~30 kg/m2(inclusive)
- Regular menstrual cycle (25~35 days)
- Basal FSH < 10 IU/L (menstrual cycle day 2~5)
Key exclusion criteria (7 listed)
- History of ≥3 previously completed IVF/ICSI-ET cycles without clinical pregnancy
- History of ≥3 recurrent spontaneous miscarriages
- Patients with high risk of ovarian hyperstimulation syndrome (OHSS)
- Primary ovarian failure or poor responders to ovarian stimulation
- Presence of pregnancy in previous 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QL1012Subcutaneous injection,starting dose within 75IU ~ 300IU determined by the age , maximum daily dose 450IU | Drug | QL1012，Recombinant Human Follicle Stimulating Hormone for Injection |
| Gonal-f ®Subcutaneous injection,starting dose within 75IU ~ 300IU determined by the age , maximum daily dose 450IU | Drug | Gonal-f ® |
Primary outcome
Number of oocytes retrieved
Time frame: 36-38 hours after hCG administration
36-38 hours after hCG administration, transvaginal ultrasound-guided aspiration was performed as required, and the number of oocytes was recorded.
9 secondary outcomes
Total dose of r-hFSH administered
Time frame: From date of randomization up to 16 days
Number of days of r-hFSH stimulation
Time frame: From date of randomization up to 16 days
Serum estradiol concentration
Time frame: From date of randomization up to 16 days
Endometrial thickness
Time frame: From date of randomization up to 16 days
Fertilization Rate of Oocytes
Time frame: Day 1 of IVF/ICSI
Rate of high-quality embryos
Time frame: 3 days after oocyte retrieval
Implantation rate
Time frame: five to six weeks after oocyte retrieval
clinical pregnancy rate
Time frame: 35 ± 4 days after embryo transfer
Ongoing pregnancy rate
Time frame: Ten weeks after embryo transfer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QL1012 and Gonal-f ® in people with Infertility, run by Qilu 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 7 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 8 Dec 2021. 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?
Number of oocytes retrieved (time frame: 36-38 hours after hCG administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2021.