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

What Was Tested

This registered phase 2 trial tested Cetrorelix.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Cetrorelix (active comparator).

Oral, once a day.

Oral, once a day.

Oral, once a day.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 240 planned participants were the target.

It was open to women only aged from 20 years up to 39 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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 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. Subjects must sign the Informed Consent Form (ICF) and be willing and able to abide by the protocol-specified study procedures.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: those who have undergone 2 or more coh of ivf/icsi-et before screening, but have not achieved clinical pregnancy; those with high risk of ovarian hyperstimulation syndrome(ohss); subjects who used gonadotropins for ovarian stimulation or drugs that affect ovarian function within 30 days prior to screening.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this Cetrorelix study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Cetrorelix.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2023-08 with completion listed for 2024-06.

It ran at 10 sites in China (10).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 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 also tracked 6 secondary outcomes, for example Ongoing pregnancy rate, The number of oocytes obtained on the day of oocyte retrieval, Clinical pregnancy rate and Adverse drug events.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cetrorelix in 240 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cetrorelix compound page, all human trials.