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Assisted Reproductive TechnologyPhase 2NCT05738382

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

A Phase 2 study testing BG2109 and Cetrorelix in people with Assisted Reproductive Technology and Controlled Ovarian Hyperstimulation, run by Bio Genuine (Shanghai) Biotech Co., Ltd. at 10 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 20 to 39 years, women only
What is being tested?
BG2109 and Cetrorelix
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
10 sitesChina
Study dates
Aug 2023to Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 39 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 11Show fewer
  • 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).

Trial locations and contacts

10 sites in 1 country.

Jing Zhao contact

021-58590032

Jing.zhao@Biogenuine.con

10 sites in 1 country

China10 sites

  • Site No5

    Changsha

  • Site No7

    Guangzhou

  • Site No9

    Haikou

  • Site No4

    Hangzhou

  • Site No8

    Hohhot

  • Site No6

    Linyi

  • Site No10

    Shenyang

  • Site No11

    Tianjin

  • Site No3

    Wuhan

  • Site No2

    Zhengzhou

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
BG2109, Cetrorelix

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BG2109Drug

    oral administration once daily

  • CetrorelixDrug

    Also called Cetrorelix Acetate

    0.25 mg, Subcutaneous injection once daily.

Study groups in NCT05738382
Study groupRoleWhat they receive
BG2109 75mgExperimentaloral, once a day
Receives: Drug: BG2109
BG2109 150mgExperimentaloral, once a day
Receives: Drug: BG2109
BG2109 200mgExperimentaloral, once a day
Receives: Drug: BG2109
CetrorelixActive comparator0.25mg, Subcutaneous injection, once a day
Receives: Drug: Cetrorelix

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Through the whole period of administration of IMP，about 5-10 days

Secondary outcomes (6)

  1. Ongoing pregnancy rate

    ongoing pregnancy is defined as at least embryo with heartbeat at 10 weeks post-embryo transfer

    Measured: At 10 weeks post-embryo transfer

  2. The number of oocytes obtained on the day of oocyte retrieval

    Measured: During the surgery of the oocyte retrieval

  3. 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

    Measured: On 30-37 days after embryo transfer

  4. Adverse drug events

    Measured: Through study completion, around 45 weeks.

  5. Pharmacokinetics(PK) endpoints

    Plasma concentration of BG2109

    Measured: On the morning of the Second and Third day of BG2109 administration, and the day of hCG injection(about 5-10days after BG2109 administration)

  6. Pharmacodynamics(PD) endpoints

    estradiol(E2), luteinizing hormone (LH) and progesterone (P) concentrations at each time point

    Measured: 30 minutes before the administration of BG2109 every morning through the whole period of IMP administration，about 5-10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2023
  2. Study startAug 2023 (estimated)
  3. Primary completionJun 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05738382
Sponsor's protocol ID
BG2109-AC-201
Status last verified
Jul 2023
First submitted
28 Jan 2023
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BG2109 and Cetrorelix in people with Assisted Reproductive Technology and Controlled Ovarian Hyperstimulation, run by Bio Genuine (Shanghai) Biotech Co., Ltd. at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jing Zhao (021-58590032, Jing.zhao@Biogenuine.con), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05738382.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.

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