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

July 25, 2023 updated by: Bio Genuine (Shanghai) Biotech Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: Through the whole period of administration of IMP，about 5-10 days
LH ≥ 10 IU/L
Through the whole period of administration of IMP，about 5-10 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ongoing pregnancy rate
Time Frame: At 10 weeks post-embryo transfer
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
Time Frame: During the surgery of the oocyte retrieval
During the surgery of the oocyte retrieval
Clinical pregnancy rate
Time Frame: On 30-37 days after embryo transfer
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
Time Frame: Through study completion, around 45 weeks.
Through study completion, around 45 weeks.
Pharmacokinetics(PK) endpoints
Time Frame: On the morning of the Second and Third day of BG2109 administration, and the day of hCG injection(about 5-10days after BG2109 administration)
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
Time Frame: 30 minutes before the administration of BG2109 every morning through the whole period of IMP administration，about 5-10 days
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bio Genuine (Shanghai) Biotech Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiaoyan Liang, Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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