Skip to main content
OpenTrials
Completed

NCT Number: NCT05149924

Efficacy and Safety of QL1012 in Women 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

20 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

The first Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.;

Treatment and study plan

QL1012

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Total dose of r-hFSH administered

    Time frame: From date of randomization up to 16 days

  2. Number of days of r-hFSH stimulation

    Time frame: From date of randomization up to 16 days

  3. Serum estradiol concentration

    Time frame: From date of randomization up to 16 days

  4. Endometrial thickness

    Time frame: From date of randomization up to 16 days

  5. Fertilization Rate of Oocytes

    Time frame: Day 1 of IVF/ICSI

  6. Rate of high-quality embryos

    Time frame: 3 days after oocyte retrieval

  7. Implantation rate

    Time frame: five to six weeks after oocyte retrieval

  8. clinical pregnancy rate

    Time frame: 35 ± 4 days after embryo transfer

  9. Ongoing pregnancy rate

    Time frame: Ten weeks after embryo transfer

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 8, 2021
Registry last updated
Dec 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.