A Phase 4 interventional study of corifollitropin alfa and Follitropin Beta in Infertility, sponsored by Vietnam National University. Completed at 2 sites in Vietnam. Open to female participants aged 35 Years to 42 Years. Per ClinicalTrials.gov, last updated 2017-08-22.
Sponsored by Vietnam National University · Phase 4, Interventional, and Treatment
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.
Stimulation regimen and assisted reproductive technology procedures
Corifollitropin Alfa Group: On day 2 or day 3 of the menstrual cycle, a single subcutaneous injection of corifollitropin alfa 150 mg/ 0.5 mL is administered (stimulation day 1).
FSH Group: Daily subcutaneous injections with recombinant FSH (Follitropin Beta) 300 international units (IU) is started on On day 2 or day 3 of the menstrual cycle (stimulation day 1) and continue up to and including stimulation day 7.
From stimulation day 8 onwards, subjects from both treatment groups will continue with a daily subcutaneous dose of FSH up to the day before human chorionic gonadotropin (hCG) administration or gonadotropin releasing hormone agonist administration day. The maximum FSH dose to continue treatment after the first 7 days is 300 IU, but the dose could be reduced when desired.
To prevent premature luteinizing hormone (LH) surges the gonadotropin releasing hormone (GnRH) antagonist (ganirelix acetate subcutaneous injection, 0.25 mg/ 0.5 mL) is administered, starting on stimulation day 5.
As soon as at least three follicles of 17 mm are observed by ultrasound, hCG or a GnRH agonist will be used for final oocyte maturation at the same day. hCG is used if 3-18 follicles and 0.2 mg triptorelin is administered if ≥ 19 follicles >11 mm are observed. About 34-36 hours thereafter, oocyte retrieval followed by IVF or intra-cytoplasmic sperm injection (ICSI) is performed. Three days after oocyte pick-up, 2 to 3 fresh embryos will be transferred. If patients have high progesterone level on day of trigger (progesterone level > 1,5 ng/ml), risk of OHSS and unfavorable endometrium, fresh transfers will be cancelled and freeze all will be recommended.
Patients using hCG for final oocyte maturation will receive luteal phase support with progestogen gel (90 mg once daily) intra-vaginally and estradiol (4 mg/day orally, twice daily) initiated on the day of oocyte retrieval or the day thereafter. Patients, using GnRH agonist for triggering, will have fresh transfer with intense luteal phase support of estradiol and progesterone (receive intense luteal phase support with estradiol and progesterone as the same dose mentioned above and progesterone 50 mg intramuscular injection per day).
Assessments
Patients will return to the clinic for pregnancy test 2 weeks after embryo transfers.
Local tolerance parameters (pain, itching, swelling and redness) are assessed by the clinical staff 30 min after injection for both corifollitropin alfa and FSH injection sites.
Clinical Outcome The primary objective is to show that the corifollitropin alfa regimen, in terms of the number of oocytes retrieved, is equivalent to the reference treatment (predefined equivalence range: -3 to +5 oocytes).
Other clinical parameters will also be evaluated: dose of FSH required, duration of stimulation, number and size of follicles (≥11mm and ≥14 mm), serum hormone levels, fertilization rate, number and quality of embryos obtained, implantation rate, miscarriage rate, and pregnancy rates.
At least 14 days after embryo transfer, a blood pregnancy test is performed. If the pregnancy test is positive, vaginal and/or abdominal ultrasonographic investigation is performed between 35 and 42 days ( 5 to 6 weeks) after embryo transfer to confirm a clinical pregnancy and at least 70 days (≥ 10 weeks) after embryo transfer to confirm an ongoing pregnancy.
Patients will be followed to one year after randomization.
All efficacy analyses will be based on the intent-to-treat (ITT) population, which included all randomized patients who will receive corifollitropin alfa or at least one dose of FSH
Safety endpoints
Occurrence of adverse events, including moderate and severe ovarian hyperstimulation syndrome (OHSS), outcome of local tolerance at injection site assessments will be evaluated as safety endpoints.
The percentage of patients with moderate or severe OHSS and local tolerance is compared between the treatment groups using Fisher's exact test.
Safety analyses will be performed on the all-subjects-treated group, which comprised all the patients who will receive either corifollitropin alfa or FSH.
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's enrollment of 400 is above the median of 135 across 1,412 interventional studies indexed under Infertility.
Browse Infertility studies →Vietnam National University is the lead sponsor of 16 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
corifollitropin alfa 150 mcg subcutaneous injection. Seven days after, combines with recombinant FSH 300 IU daily subcutaneous injection
Drug: corifollitropin alfa
300 IU of recombinant FSH, daily subcutaneous injection
Drug: Follitropin Beta
Drug is injected subcutaneously. Seven days after, 300 IU FSH daily injected subcutaneously, until at least two leading ovarian follicles reach 17mm in diameter.
Also known as: Elonva
Drug is injected subcutaneously, daily, until at least two leading ovarian follicles reach 17mm in diameter.
Also known as: Puregon
number of oocytes
in 10 minutes after oocyte retrieval, total number of oocytes retrieved is counted and recorded
Time frame: 10 minutes after oocyte retrieval completed
Rate of moderate and severe ovarian hyperstimulation syndrome
symptoms of ovarian hyperstimulation syndrome are followed and recorded until 8 days after oocyte retrieval.
Time frame: 8 days after oocyte retrieval
Live birth
delivery of live birth
Time frame: at the time of delivery
number of MII oocytes
Number of mature oocytes collected
Time frame: 2 hours after oocyte retrieval completed
number of 2PN
number of two pronuclear (2PN) fertilized oocytes
Time frame: 18 hours after sperm injection
number of mature follicles >11 mm
number of mature follicles \>11 mm in diameter
Time frame: on the day of hCG administration
estradiol level
serum level of estradiol
Time frame: on the day of hCG administration
FSH dose
total dose of FSH
Time frame: calculated on the day of hCG administration
implantation rate
number of sacs with heart beat per total number of embryos transferred
Time frame: 5 to 6 weeks after embryo transfer
Clinical pregnancy
gestational sac on ultrasound
Time frame: at 5 to 6 six weeks after embryo transfer
Ectopic pregnancy
The presence of a gestational sac outside the uterine cavity shown on sonography or laparoscopy
Time frame: 7 to 8 weeks after embryo transfer
Miscarriage
Loss of clinical pregnancy
Time frame: 7 to 12 weeks of gestation
Multiple pregnancy
more than one gestational sacs or heart beats on ultrasound
Time frame: at 7 weeks of gestation
Ongoing pregnancy
At least one gestational sac on ultrasound
Time frame: at 10 weeks after embryo transfer
Cumulative ongoing pregnancy
Cumulative ongoing pregnancy at 12 months after randomization
Time frame: at 12 months after randomization
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
Time frame: measured at or after 20 weeks gestation
Pre-eclampsia
hypertension plus proteinuria or other organ involvement, neurologic or hematologic complications, uteroplacental dysfunction, or fetal growth restriction
Time frame: measured at or after 20 weeks gestation
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)
Time frame: measured at or after 20 weeks gestation
Gestational diabetes mellitus
Diagnosed using a 75g oral glucose tolerance test; fasting: 92 mg/dL \[5.1 mmol/L\]; 2-hour: 153 mg/dL \[8.5 mmol/L\]
Time frame: measured at or after 20 weeks gestation
Prematurity
preterm birth if any
Time frame: at 24 weeks gestation, at 32 weeks gestation, at 34 weeks gestation, and at 37 weeks' gestation
Cumulative live birth
cumulative live birth delivery at 12 months after randomization
Time frame: at 12 months after randomization
Ran from Jun 2015 to primary completion in Aug 2016, 14 months.
Of 73 non-industry phase 4 interventional studies under Infertility, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 82. This study's 14 months is below that.
Counting every sponsor, half of 80 studies reached it within 33 months; a quarter within 19 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Corifollitropin alfa · Follitropin beta
Vietnam National University