Clinical trial NCT02458768: Multicenter, Randomized, Open Label, Parallel Study to Evaluate the Efficacy & Safety of IVF-M HP Inj. vs. Menopur® Inj.
Official title: A Multicenter, Randomized, Open Label, Parallel Study to Evaluate the Efficacy & Safety of s.c. Administration of IVF-M HP Inj. Versus Menopur® Inj. in Infertility Women Undergoing Controlled Ovarian Hyperstimulation for Assisted Reproductive Technologies (ART) Such as in Vitro Fertilization-embryo Transfer (IVF-ET)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility, Female
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2015-06-01
Enrollment: 112
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 abnormal ovarian reserve test (i.e. Antral follicle Count (AFC) \< 5 follicles or Anti-Mullerian hormone (AMH) \< 0.5 ng/ml)
* Those with abnormal metrorrhagia due to unknown cause at the screening
* Subjects with submucosal uterine leiomyoma
* Subjects with at least borderline ovarian tumor
* Subjects with a history or malignant tumor in breast
* Subjects with hydrosalpinx not removed by operation
* Subjects with the Thyroid Stimulating Hormone (TSH) level out of the normal range at the screening
* Subjects with a history of malignant tumor within 5 years prior to the screening
* Subjects with severe disease potentially affecting the study such as pituitary insufficiency upon the investigator's judgment (e.g., heart failure, renal failure, hepatic failure or adrenal insufficiency etc.)
* Subject with HIV- or syphilis-positive result at the screening
* Subjects with a psychiatric disorder at the screening or those who failed in understanding the objective and method of this clinical study
* Subject diagnosed with alcohol or drug abuse within 3 months prior to the screening
* Subjects with a history of hypersensitivity to the investigational products of this clinical study
* Subjects with a current or history of thromboembolism in vein or artery
* Subjects with a history of genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
* Subjects who had participated in another clinical study related to a drug administration after the enrollment in this study or who had participated in another clinical study within 3 months prior to the enrollment in this study
* Others including the subjects for whom it was considered difficult to conduct this clinical study upon the principal investigator's judgment

Primary outcomes:
measure: Number of Retrieved Oocytes
timeFrame: 36 hrs (±3 hrs) after administration of the ovulation stimulant
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: