Current partner codePEPTIDESDE
NCT05738382·Phase 2·INTERVENTIONAL

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

Status

Unknown

Phase

Phase 2

Enrollment

240

Locations

10

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Full 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.

Interventions

Treatment arms and agents.

DRUG

BG2109

oral administration once daily

DRUG

Cetrorelix

0.25 mg, Subcutaneous injection once daily.

Timeline

From registration to results.

  1. First posted

    Feb 22, 2023

  2. Study start

    Aug 2023

  3. Primary completion

    Jun 2024

  4. Study completion

    Dec 2024

  5. Results posted

    Not reported

  6. Registry updated

    Jul 27, 2023

Outcomes

What the study measures.

Primary outcomes

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

Secondary outcomes

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

The number of oocytes obtained on the day of oocyte retrieval

Time frame · 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

Adverse drug events

Time frame · 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

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

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
39 Years
Sex
FEMALE
Healthy volunteers
No

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 locations

10 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Site No5

Changsha, China

Site No7

Guangzhou, China

Site No9

Haikou, China

Site No4

Hangzhou, China

Site No8

Hohhot, China

Site No6

Linyi, China

Site No10

Shenyang, China

Site No11

Tianjin, China

Site No3

Wuhan, China

Site No2

Zhengzhou, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Cetrorelix.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.