Efficacy and Safety of QL1012 in Women for Assisted Reproductive Treatment

Phase 3

Completed

• Conditions: Infertility
• Interventions: Drug: Gonal-f ®; Drug: QL1012

• Registration Number: NCT05149924
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-31
• Primary Completion: 2019-10-17
• Study Completion: 2019-10-17
• Status Verified: 2021-11
• Study First Submitted: 2021-11-12
• Study First Submitted QC: 2021-11-25
• Last Update Submitted: 2021-11-25
• Study First Posted: 2021-12-08
• Last Update Posted: 2021-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 354

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.;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gonal-f ®	Gonal-f ®	-
QL1012，Recombinant Human Follicle Stimulating Hormone for Injection	QL1012	-

Primary Outcome Measures

Name	Time	Method
Number of oocytes retrieved	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.

Secondary Outcome Measures

Name	Time	Method
Serum estradiol concentration	From date of randomization up to 16 days
Number of days of r-hFSH stimulation	From date of randomization up to 16 days
Rate of high-quality embryos	3 days after oocyte retrieval
Fertilization Rate of Oocytes	Day 1 of IVF/ICSI
clinical pregnancy rate	35 ± 4 days after embryo transfer
Endometrial thickness	From date of randomization up to 16 days
Ongoing pregnancy rate	Ten weeks after embryo transfer
Total dose of r-hFSH administered	From date of randomization up to 16 days
Implantation rate	five to six weeks after oocyte retrieval

Trial Locations

Locations (1)

The first Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China