NCT05738382

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

January 28, 2023

Last Update Submit

July 25, 2023

Conditions

Assisted Reproductive TechnologyControlled Ovarian Hyperstimulation

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (6)

  • Ongoing pregnancy rate

    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

    On 30-37 days after embryo transfer

  • Adverse drug events

    Through study completion, around 45 weeks.

  • Pharmacokinetics(PK) endpoints

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

  • +1 more secondary outcomes

Study Arms (4)

BG2109 75mg

EXPERIMENTAL

oral, once a day

Drug: BG2109

BG2109 150mg

EXPERIMENTAL

oral, once a day

Drug: BG2109

BG2109 200mg

EXPERIMENTAL

oral, once a day

Drug: BG2109

Cetrorelix

ACTIVE COMPARATOR

0.25mg, Subcutaneous injection, once a day

Drug: Cetrorelix

Interventions

BG2109DRUG

oral administration once daily

BG2109 150mgBG2109 200mgBG2109 75mg
CetrorelixDRUG

0.25 mg, Subcutaneous injection once daily.

Also known as: Cetrorelix Acetate
Cetrorelix

Eligibility Criteria

Age20 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Site No5

Changsha, China

Location

Site No7

Guangzhou, China

Location

Site No9

Haikou, China

Location

Site No4

Hangzhou, China

Location

Site No8

Hohhot, China

Location

Site No6

Linyi, China

Location

Site No10

Shenyang, China

Location

Site No11

Tianjin, China

Location

Site No3

Wuhan, China

Location

Site No2

Zhengzhou, China

Location

MeSH Terms

Interventions

cetrorelix

Study Officials

  • Xiaoyan Liang

    Sixth Affiliated Hospital, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Zhao

CONTACT

021-58590032Jing.zhao@Biogenuine.con

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Masked for BG2109 dose groups and open for the active controlled group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2023

First Posted

February 22, 2023

Study Start

August 1, 2023

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

July 27, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(10)