Multicenter, Randomized, Open Label, Parallel Study to Evaluate the Efficacy & Safety of IVF-M HP… (NCT02458768) | Clinical Trial Compass
CompletedPhase 4
Multicenter, Randomized, Open Label, Parallel Study to Evaluate the Efficacy & Safety of IVF-M HP Inj. vs. Menopur® Inj.
112 participantsStarted 2013-07
Plain-language summary
The objective of this study was to demonstrate the non-inferiority of IVFM HP Inj. by evaluating its efficacy versus Menopur® Inj. in infertility women undergoing the in vitro fertilization and embryo transfer (IVF-ET) among the assisted reproductive technologies.
Who can participate
Age range20 Years – 39 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult women from 20 through 39 years of age at the screening
* Subjects with the mean menstrual cycle day (MCD) of 25 to 35 days
* Subjects with the Follicle Stimulating Hormone (FSH) concentration at the screening not exceeding the upper limit of the normal range (ULN)
* Those diagnosed with infertility due to at least one of the following causes of infertility
* Fallopian tubal factor
* Infertility due to unknown cause
* Male infertility
* Complex factor
* Subjects with the normal ovarian and uterine function
* Subjects with not more than 3 times of the prior experience of in vitro fertilization
* Subjects who had neither administered clomiphene citrate within 30 days nor gonadotropin within 14 days of the IP administration day
* Subjects who were informed on the objective, method and effect etc. of the clinical study and signed the informed consent form
Exclusion Criteria:
* Subjects contraindicated to pregnancy
* Subjects with BMI \> 30 (BMI; kg/m2)
* Subjects diagnosed with polycystic ovary syndrome (PCOS)
* Subjects who had experienced previously at least Grade 4 ovarian hyperstimulation syndrome (OHSS)
* Subjects with poor response to gonadotropin (According to the Bologna criteria\* below) \*At least two of the following three features must be present:
â‘ Advanced maternal age (\>=40 years) or any other risk factor for Poor Ovarian Response (POR)
② A previous POR (\<=3 oocyte with a conventional stimulation protocol)
③ An abno…
What they're measuring
1
Number of Retrieved Oocytes
Timeframe: 36 hrs (±3 hrs) after administration of the ovulation stimulant