CompletedPhase 3

Efficacy and Safety of QL1012 in Women for Assisted Reproductive Treatment

China354 participantsStarted 2018-10-31

Plain-language summary

The study is conducted to confirm equivalence between QL1012 (a new biosimilar formulation of Recombinant Human Follicle-stimulating Hormone) and Gonal-f® with respect to the number of oocytes retrieved in women for assisted reproductive treatment.

Who can participate

Age range20 Years – 39 Years

SexFEMALE

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Inclusion criteria

✓. Signed informed consent
✓. Aged 20 \~ 39 years(inclusive)
✓. Body mass index (BMI) between 18\~30 kg/m2(inclusive)
✓. Regular menstrual cycle (25\~35 days)
✓. Basal FSH \< 10 IU/L (menstrual cycle day 2\~5)

Exclusion criteria

✕. History of ≥3 previously completed IVF/ICSI-ET cycles without clinical pregnancy
✕. History of ≥3 recurrent spontaneous miscarriages
✕. Patients with high risk of ovarian hyperstimulation syndrome (OHSS)
✕. Primary ovarian failure or poor responders to ovarian stimulation
✕. Presence of pregnancy in previous 3 months
✕. Presence of clinically significant systemic disease, endocrine disease or metabolic abnormalities
✕. History of malignant tumors of the ovary, breast, uterus, hypothalamus, pituitary gland, etc.;

What they're measuring

Number of oocytes retrieved

Timeframe: 36-38 hours after hCG administration

Trial details

NCT IDNCT05149924

SponsorQilu Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-10-17

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