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 range

20 Years – 39 Years

Sex

FEMALE

See this in plain English?

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: ① 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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Retrieved Oocytes

Timeframe: 36 hrs (±3 hrs) after administration of the ovulation stimulant

Trial details

NCT IDNCT02458768

SponsorLG Life Sciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-11

Results submitted2015-11-23

View on ClinicalTrials.gov More Infertility, Female trials