Efficacy and Safety of BG2109 During Controlled Ovarian Hyperstimulation in Female Subjects Undergoing ART Procedures

A Randomized, Double-blind, Open for Active Comparator, Parallel, Multi-center Phase II Study to Explore the Efficacy, Safety and Tolerability of BG2109 Compared With Cetrorelix During COH in Female Subjects Undergoing ART Procedures

To explore the optimal effective daily dose of BG2109 to suppress premature luteinizing hormone (LH) surge during COH in female subjects undergoing ART procedures.

Study Overview

• Status: Not yet recruiting
• Conditions: Assisted Reproductive Technology; Controlled Ovarian Hyperstimulation
• Intervention / Treatment: Drug: BG2109; Drug: Cetrorelix

Detailed Description

This study is a randomized, double-blind, open for active comparator, parallel, multi-center phase II dose-finding clinical study to explore the efficacy, safety and tolerability of different doses of BG2109 compared with Cetrorelix during Controlled Ovarian Hyperstimulation (COH) in Chinese female subjects undergoing Assisted Reproductive Technology (ART) procedures.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jing Zhao; Phone Number: 021-58590032; Email: Jing.zhao@Biogenuine.con

Study Locations

• China
  • Changsha, China
    • Site No5
  • Guangzhou, China
    • Site No7
  • Haikou, China
    • Site No9
  • Hangzhou, China
    • Site No4
  • Hohhot, China
    • Site No8
  • Linyi, China
    • Site No6
  • Shenyang, China
    • Site No10
  • Tianjin, China
    • Site No11
  • Wuhan, China
    • Site No3
  • Zhengzhou, China
    • Site No2

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Married infertile women aged 20 to 39 years (both inclusive), who are diagnosed with tubal infertility, unexplained infertility, grade I-II endometriosis, or spouses diagnosed with male factor infertility, who meet the criteria for IVF and/or ICSI) using fresh or frozen semen from the male spouse or sperm donor
• BMI 18-25 kg/m2 (both inclusive), body weight range 45-80kg (both inclusive)
• Subjects must have regular menstrual cycles, specifically defined as ≥25 days, ≤35 days.
• The serum sex hormone levels during the screening period must be performed in the early follicular phase, and the basal serum follicle-stimulating hormone (FSH) <10 IU/L, LH, estradiol(E2), prolactin(PRL),testosterone(T) levels are within the laboratory normal range, or the investigator considers them as abnormal but not clinically significant
• The subject is clinically assessed and agree to undergo fresh cycle embryo transfer in the first IVF-ET/ ICSI-Embryo Transfer(ET) cycle, with a maximum of two embryos transferred.
• Within 1 year before randomization, the presence of bilateral ovaries is clearly visible on transvaginal ultrasonography with no significant abnormalities, and appendages are normal. Both ovaries must be available for oocyte retrieval
• Subjects must sign the Informed Consent Form (ICF) and be willing and able to abide by the protocol-specified study procedures

Exclusion Criteria:

• Those who have undergone 2 or more COH of IVF/ICSI-ET before screening, but have not achieved clinical pregnancy.
• Those with previous IVF or ART failure due to sperm/fertilization problems whose related medical condition has not been improved.
• Either subjects or their spouses or both of them are known to carry abnormal chromosomal structures, or patients known to have single-gene genetic diseases or serious diseases with genetic susceptibility requiring Preimplantation Genetic Diagnosis(PGD) before embryo transfer.
• Those with high risk of ovarian hyperstimulation syndrome(OHSS)
• Those with low ovarian function at screening, with at least one of the following: poor ovarian response in the past; less than 6 antral follicles (AFC) with a diameter of < 10 mm seen on bilateral ovary transvaginal ultrasonography at Day2-3 of menstrual cycle; anti-mullerian hormone(AMH) < 1.1 ng/ml.
• Subjects who used gonadotropins for ovarian stimulation or drugs that affect ovarian function within 30 days prior to screening.
• Subjects with abnormal thinprep cytology test(TCT) results that are judged by the investigator as clinically significant and require treatment within 6 months before screening.
• As judged by the investigator, subjects with clinically significant gynecological diseases at screening
• Those previously or prior randomization suffering from the cancer of uterine, ovarian, breast or hypothalamus or pituitary gland.
• Those with a positive serum β-hCG test result at the screening visit or the visit on Day 1 of ovarian stimulation.
• During COH, LH ≥10 U/L, and the LH level was 2.5 times higher than the baseline value before D0 (inclusive).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BG2109 75mg; oral, once a day	Drug: BG2109; oral administration once daily
Experimental: BG2109 150mg; oral, once a day	Drug: BG2109; oral administration once daily
Experimental: BG2109 200mg; oral, once a day	Drug: BG2109; oral administration once daily
Active Comparator: Cetrorelix; 0.25mg, Subcutaneous injection, once a day	Drug: Cetrorelix; 0.25 mg, Subcutaneous injection once daily.; Other Names: Cetrorelix Acetate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suppression rate of premature LH surge from the treatment of investigational medicinal products(IMP) until the day of human chorionic gonadotropin(hCG) injection	LH ≥ 10 IU/L	Through the whole period of administration of IMP，about 5-10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ongoing pregnancy rate	ongoing pregnancy is defined as at least embryo with heartbeat at 10 weeks post-embryo transfer	At 10 weeks post-embryo transfer
The number of oocytes obtained on the day of oocyte retrieval		During the surgery of the oocyte retrieval
Clinical pregnancy rate	clinical pregnancy is defined as the presence of at least one gestational sac in or outside the uterus during 30-37 days after embryo transfer	On 30-37 days after embryo transfer
Adverse drug events		Through study completion, around 45 weeks.
Pharmacokinetics(PK) endpoints	Plasma concentration of BG2109	On the morning of the Second and Third day of BG2109 administration, and the day of hCG injection(about 5-10days after BG2109 administration)
Pharmacodynamics(PD) endpoints	estradiol(E2), luteinizing hormone (LH) and progesterone (P) concentrations at each time point	30 minutes before the administration of BG2109 every morning through the whole period of IMP administration，about 5-10 days

Collaborators and Investigators

• Sponsor: Bio Genuine (Shanghai) Biotech Co., Ltd.
• Investigators: Principal Investigator: Xiaoyan Liang, Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 28, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Actual): February 22, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Ovarian Hyperstimulation Syndrome; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Cetrorelix
• Other Study ID Numbers: BG2109-AC-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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