Efficacy and Safety of QL1012 in Women for Assisted Reproductive Treatment

Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05149924
• Other study ID #: QL1012-002
• Status: Completed
• Phase: Phase 3
• Start date: October 31, 2018
• Est. completion date: October 17, 2019

Study information

• Verified date: November 2021
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: October 17, 2019
• Est. primary completion date: October 17, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

Inclusion Criteria:

1. Signed informed consent

2. Aged 20 ~ 39 years(inclusive)

3. Body mass index (BMI) between 18~30 kg/m2(inclusive)

4. Regular menstrual cycle (25~35 days)

5. Basal FSH < 10 IU/L (menstrual cycle day 2~5)

Exclusion Criteria:

1. History of =3 previously completed IVF/ICSI-ET cycles without clinical pregnancy

2. History of =3 recurrent spontaneous miscarriages

3. Patients with high risk of ovarian hyperstimulation syndrome (OHSS)

4. Primary ovarian failure or poor responders to ovarian stimulation

5. Presence of pregnancy in previous 3 months

6. Presence of clinically significant systemic disease, endocrine disease or metabolic abnormalities

7. History of malignant tumors of the ovary, breast, uterus, hypothalamus, pituitary gland, etc.;

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• QL1012
Subcutaneous injection,starting dose within 75IU ~ 300IU determined by the age , maximum daily dose 450IU
• Gonal-f ®
Subcutaneous injection,starting dose within 75IU ~ 300IU determined by the age , maximum daily dose 450IU

Locations

Country	Name	City	State
China	The first Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	36-38 hours after hCG administration
Secondary	Total dose of r-hFSH administered		From date of randomization up to 16 days
Secondary	Number of days of r-hFSH stimulation		From date of randomization up to 16 days
Secondary	Serum estradiol concentration		From date of randomization up to 16 days
Secondary	Endometrial thickness		From date of randomization up to 16 days
Secondary	Fertilization Rate of Oocytes		Day 1 of IVF/ICSI
Secondary	Rate of high-quality embryos		3 days after oocyte retrieval
Secondary	Implantation rate		five to six weeks after oocyte retrieval
Secondary	clinical pregnancy rate		35 ± 4 days after embryo transfer
Secondary	Ongoing pregnancy rate		Ten weeks after embryo transfer