Efficacy and Safety of QL1012 in Women for Assisted Reproductive Treatment

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Drug: QL1012; Drug: Gonal-f ®

• Study Type: Interventional
• Enrollment (Actual): 354
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • The First Affiliated Hospital of Zhengzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QL1012，Recombinant Human Follicle Stimulating Hormone for Injection	Drug: QL1012; Subcutaneous injection,starting dose within 75IU ~ 300IU determined by the age , maximum daily dose 450IU
Active Comparator: Gonal-f ®	Drug: Gonal-f ®; Subcutaneous injection,starting dose within 75IU ~ 300IU determined by the age , maximum daily dose 450IU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2018
• Primary Completion (Actual): October 17, 2019
• Study Completion (Actual): October 17, 2019

Study Registration Dates

• First Submitted: November 12, 2021
• First Submitted That Met QC Criteria: November 25, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: November 25, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: QL1012-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No