Identify Effective Doses of SHR7280 Tablets in Controlled Ovarian Hyperstimulation (COH) for Fema… (NCT05082233) | Clinical Trial Compass
CompletedPhase 2
Identify Effective Doses of SHR7280 Tablets in Controlled Ovarian Hyperstimulation (COH) for Female Subjects Undergoing Assisted Reproductive Technology (ART)
China85 participantsStarted 2022-03-06
Plain-language summary
This study is a multicentre, open-label phase II dose-finding clinical trial that will recruit approximately 120 female subjects undergoing COH for in vitro fertilization (IVF) or intracytoplasmic single sperm injection (ICSI). We set up three SHR7280 tablets dose groups of 300 mg BID, 200 mg BID, and 200 mg QD with 40 subjects in each group, besides, a group of 400mg bid is set as an alternative.
Who can participate
Age range20 Years – 39 Years
SexFEMALE
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Inclusion criteria
✓. Married infertile female subjects aged 20 to 39 years with indications for in vitro fertilization-embryo transfer (IVF-ET) or intracytoplasmic monosperm microinjection (ICSI) techniques.
✓. Body mass index (BMI) of 18 to 28 kg/m2.
✓. Regular menstrual cycle (24 to 35 days) for the last 3 months prior to screening.
✓. Screening serum sex hormone levels must be performed on day 2 to 3 in the menstrual cycle and meet basal serum follicle stimulating hormone (FSH) \< 10 IU/L; LH, estradiol (E2), progesterone (P), prolactin (PRL), and total testosterone levels within the normal laboratory range, or the investigator considers the abnormality without clinical significance; 1.2 ng/mL \< anti-müllerian hormone (AMH) \< 4.0 ng/mL.
✓. Expected normal ovarian response.
✓. Clinical feasible and willingness of the subject to undergo fresh cycle transfer with one or two embryos at a time in the first IVF-ET cycle.
✓. Able and willing to provide a written informed consent.
Exclusion criteria
✕. Subjects underwent 3 or more controlled ovarian stimulation cycles of IVF/ICSI-ET prior to screening without achieving clinical pregnancy.
✕. Previous IVF or ART failure due to sperm/fertilization problems and no improvement in related medical condition.
✕. Subjects had spontaneous abortion≥2 times.
✕
What they're measuring
1
Inhibition rate of early LH serge with different oral doses of SHR7280 tablets from the 1st day of study drug administration to the date of hCG injection
Timeframe: Through the whole period of oral administration of SHR7280, generally 5-7 days)
. Subjects at high risk of OHSS, judged by the investigator according to the Golan classification (e.g., those with moderate to severe OHSS during previous superovulatory cycles, polycystic ovary syndrome (PCOS) \[refer to the 2018 Chinese PCOS guidelines\] \[1\], or with previous cancelled cycles due to OHSS).
✕. Subjects with low ovarian function meeting at least one of the following items: poor previous ovarian response (≤3 ovums obtained with previous conventional adequate Gn stimulation regimen); less than 7 follicles of 2-9 mm diameter (AFC) count visible on vaginal ultrasound in both ovaries; anti-mullerian hormone (AMH) \< 1.1 ng/mL.
✕. Any pregnancy that occurred within 3 months prior to screening date.
✕. Subjects with clinically significant abnormal cervical findings within 6 months prior to screening (TCT).