Infertility Clinical Trial
Official title:
An Efficacy and Safety Study of Corifollitropin Alfa Versus Daily Follitropin Beta for Controlled Ovarian Stimulation in Women 35-42 Years Old With a Body Weight ≥ 50 kg Undergoing IVF Treatment.
Verified date | August 2017 |
Source | Vietnam National University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A prospective, randomized, controlled study to explore the efficacy and safety of using
either corifollitropin alfa 150 mcg or daily recombinant follicle stimulation hormone (FSH)
300 international unit (IU) for the stimulation treatment of subjects undergoing controlled
ovarian stimulation prior to IVF.
The study is designed as a non-inferiority trial. The sample size for this trial of 400
subjects, in both groups, being treated for one IVF cycle is based upon the primary endpoint
of the number of oocytes retrieved.
Status | Completed |
Enrollment | 400 |
Est. completion date | August 15, 2017 |
Est. primary completion date | August 10, 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 35 Years to 42 Years |
Eligibility |
Inclusion Criteria: - Each subject must be willing and able to provide written informed consent for the study. - Each subject must be female with years of age =35 to =42 at the time of recruitment.. - Each subject must have an indication for controlled ovarian stimulation and IVF - Each subject must have a body weight = 50.0 kg, with a body mass index (BMI) =18.0 to =32.0 kg/m2. - Each subject must have a regular spontaneous menstrual cycle with an intra-individual variation not outside the 24 to 35 days range. - For each subject, ejaculatory sperm must be available (use of donated and/or cryopreserved sperm is allowed; sperm obtained via surgical sperm retrieval is not allowed). - Each subject must have results of clinical laboratory test (complete blood count, blood chemistries, and urinalysis) within normal limits or clinically acceptable to the investigator, as measured by the local laboratory at screening. A normal cervical smear result, obtained within 12 months, otherwise it must be obtained during screening. - Each subject must have results of a physical examination, including blood pressure, within normal limits or clinically acceptable limits to the investigator. - Each subject must have normal ovarian reserve, based on anti-Mullerian hormon (AMH) of 1.38 - 3.25ng/ml or an antral follicle count (AFC) of 7-20, taken within 2 months prior to corifollitropin alfa start. - Each subject must be able to adhere to dose and visit schedules and willing to disclose any medical events to the investigator. Exclusion Criteria: - The subject has a recent (ie, within 3 years) history of/ or any current endocrine abnormality (irrespective whether the patient is stabilized on treatment). - The subject has a history of ovarian hyper-response (ie, previous IVF cycle with more than 30 follicles =11 mm on ultrasound) or ovarian hyperstimulation syndrome (OHSS). - The subject has a history of/or current polycystic ovary syndrome (PCOS) - The subject has more 20 basal antral follicles <11 mm (both ovaries combined) as measured on ultrasound in the early follicle phase (menstrual cycle day 2-5). - The subject has less than 2 ovaries in any other ovarian abnormality (including endometrioma > 10 mm; visible on ultrasound). - The subject has unilateral or bilateral hydrosalpinx (visible on ultrasound, less clipped). - The subject has any intra-uterine fibroids >5 cm or any clinically relevant pathology, which could impair embryo implantation or pregnancy continuation. - The subject has more than three unsuccessful treatment cycles for IVF/ICSI. - The subject has a history of non- or low avarian response to FSH / Human Menopausal Gonadotropin (hMG) treatment (ie, previous COS cycle cancelled due to insufficient ovarian response or =3 oocytes obtained). - The subject has a history of current miscarriage (3 or more, even when explained). - The subject has FSH > 15.0 IU/L or LH > 12 .0 IU/L as measured by the local laboratory (sample taken during the early follicle phase: menstrual cycle day 2 to 5). - The subject has tested positive for human immunodeficiency virus (HIV) or Hepatitis B (results obtained within one year) . - The subject has contra-indications for the use of gonadotropins (eg, tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, or ovarian cysts) or GnRH antagonist (eg, hypersensitivity, pregnancy/lactation). - The subject has a concomitant use of either LH or hMG/urinary FSH preparations in study cycle. - The subject has a recent history of/or current epilepsy, thrombophilia, diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary or auto-immune disease requiring regular treatment. - The subject or the sperm donor has known gene defects, genetic abnormalities, or abnormal karyotyping, relevant for the current indications or for the health of the offspring. - The subject smokes or has recently stopped smoking (ie, within the last 3 months prior to signing ICF). - The subject has a history or presence of alcohol or drug abuse within 12 months prior to signing informed consent. - The subject has an allergy/ sensitivity to investigational drugs or their excipients. - The subject has used any experimental drugs within 3 months prior to signing informed consent. - The subject is participating in any other clinical study (excluding surveys). |
Country | Name | City | State |
---|---|---|---|
Vietnam | My Duc Hospital | Ho Chi Minh City | |
Vietnam | Research Center for Genetics and Reproductive Health | Ho Chi Minh City |
Lead Sponsor | Collaborator |
---|---|
Vietnam National University | M? Ð?c Hospital, Merck Sharp & Dohme Corp. |
Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | number of oocytes | in 10 minutes after oocyte retrieval, total number of oocytes retrieved is counted and recorded | 10 minutes after oocyte retrieval completed | |
Secondary | Rate of moderate and severe ovarian hyperstimulation syndrome | symptoms of ovarian hyperstimulation syndrome are followed and recorded until 8 days after oocyte retrieval. | 8 days after oocyte retrieval | |
Secondary | Live birth | delivery of live birth | at the time of delivery | |
Secondary | number of MII oocytes | Number of mature oocytes collected | 2 hours after oocyte retrieval completed | |
Secondary | number of 2PN | number of two pronuclear (2PN) fertilized oocytes | 18 hours after sperm injection | |
Secondary | number of mature follicles >11 mm | number of mature follicles >11 mm in diameter | on the day of hCG administration | |
Secondary | estradiol level | serum level of estradiol | on the day of hCG administration | |
Secondary | FSH dose | total dose of FSH | calculated on the day of hCG administration | |
Secondary | implantation rate | number of sacs with heart beat per total number of embryos transferred | 5 to 6 weeks after embryo transfer | |
Secondary | Clinical pregnancy | gestational sac on ultrasound | at 5 to 6 six weeks after embryo transfer | |
Secondary | Ectopic pregnancy | The presence of a gestational sac outside the uterine cavity shown on sonography or laparoscopy | 7 to 8 weeks after embryo transfer | |
Secondary | Miscarriage | Loss of clinical pregnancy | 7 to 12 weeks of gestation | |
Secondary | Multiple pregnancy | more than one gestational sacs or heart beats on ultrasound | at 7 weeks of gestation | |
Secondary | Ongoing pregnancy | At least one gestational sac on ultrasound | at 10 weeks after embryo transfer | |
Secondary | Cumulative ongoing pregnancy | Cumulative ongoing pregnancy at 12 months after randomization | at 12 months after randomization | |
Secondary | Pregnancy-induced hypertension | systolic blood pressure =140 mmHg or diastolic pressure =90 mmHg on two occasions, two hours apart, or severely elevated single blood pressure measurement requiring antihypertensive medication | measured at or after 20 weeks gestation | |
Secondary | Pre-eclampsia | hypertension plus proteinuria or other organ involvement, neurologic or hematologic complications, uteroplacental dysfunction, or fetal growth restriction | measured at or after 20 weeks gestation | |
Secondary | HELLP syndrome | Elevated liver enzyme levels (aspartate aminotransferase =100 U/L), thrombocytopenia (platelet count <100,000/mm3), elevated serum creatinine level (=1.5 mg/dL [132.6 µmol/L]) and/or hemolysis (hemoglobin <10 g/dL) | measured at or after 20 weeks gestation | |
Secondary | Gestational diabetes mellitus | Diagnosed using a 75g oral glucose tolerance test; fasting: 92 mg/dL [5.1 mmol/L]; 2-hour: 153 mg/dL [8.5 mmol/L] | measured at or after 20 weeks gestation | |
Secondary | Prematurity | preterm birth if any | at 24 weeks gestation, at 32 weeks gestation, at 34 weeks gestation, and at 37 weeks' gestation | |
Secondary | Cumulative live birth | cumulative live birth delivery at 12 months after randomization | at 12 months after randomization |
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