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Efficacy of Corifollitropin Alfa Versus Follitropin Beta in Aged IVF (In-vitro Fertilization) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02466204
Recruitment Status : Completed
First Posted : June 9, 2015
Last Update Posted : August 22, 2017
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Mỹ Đức Hospital
Information provided by (Responsible Party):
Manh Tuong Ho, Vietnam National University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Infertility Drug: corifollitropin alfa Drug: Follitropin Beta Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : June 1, 2015
Actual Primary Completion Date : August 10, 2016
Actual Study Completion Date : August 15, 2017

Arm Intervention/treatment
Active Comparator: corifollitropin alfa (long action FSH)
corifollitropin alfa 150 mcg subcutaneous injection. Seven days after, combines with recombinant FSH 300 IU daily subcutaneous injection
Drug: corifollitropin alfa
Drug is injected subcutaneously. Seven days after, 300 IU FSH daily injected subcutaneously, until at least two leading ovarian follicles reach 17mm in diameter.
Other Name: Elonva

Active Comparator: Follitropin Beta (recombinant FSH)
300 IU of recombinant FSH, daily subcutaneous injection
Drug: Follitropin Beta
Drug is injected subcutaneously, daily, until at least two leading ovarian follicles reach 17mm in diameter.
Other Name: Puregon




Primary Outcome Measures :
  1. number of oocytes [ Time Frame: 10 minutes after oocyte retrieval completed ]
    in 10 minutes after oocyte retrieval, total number of oocytes retrieved is counted and recorded


Secondary Outcome Measures :
  1. Rate of moderate and severe ovarian hyperstimulation syndrome [ Time Frame: 8 days after oocyte retrieval ]
    symptoms of ovarian hyperstimulation syndrome are followed and recorded until 8 days after oocyte retrieval.

  2. Live birth [ Time Frame: at the time of delivery ]
    delivery of live birth

  3. number of MII oocytes [ Time Frame: 2 hours after oocyte retrieval completed ]
    Number of mature oocytes collected

  4. number of 2PN [ Time Frame: 18 hours after sperm injection ]
    number of two pronuclear (2PN) fertilized oocytes

  5. number of mature follicles >11 mm [ Time Frame: on the day of hCG administration ]
    number of mature follicles >11 mm in diameter

  6. estradiol level [ Time Frame: on the day of hCG administration ]
    serum level of estradiol

  7. FSH dose [ Time Frame: calculated on the day of hCG administration ]
    total dose of FSH

  8. implantation rate [ Time Frame: 5 to 6 weeks after embryo transfer ]
    number of sacs with heart beat per total number of embryos transferred

  9. Clinical pregnancy [ Time Frame: at 5 to 6 six weeks after embryo transfer ]
    gestational sac on ultrasound

  10. Ectopic pregnancy [ Time Frame: 7 to 8 weeks after embryo transfer ]
    The presence of a gestational sac outside the uterine cavity shown on sonography or laparoscopy

  11. Miscarriage [ Time Frame: 7 to 12 weeks of gestation ]
    Loss of clinical pregnancy

  12. Multiple pregnancy [ Time Frame: at 7 weeks of gestation ]
    more than one gestational sacs or heart beats on ultrasound

  13. Ongoing pregnancy [ Time Frame: at 10 weeks after embryo transfer ]
    At least one gestational sac on ultrasound

  14. Cumulative ongoing pregnancy [ Time Frame: at 12 months after randomization ]
    Cumulative ongoing pregnancy at 12 months after randomization

  15. Pregnancy-induced hypertension [ Time Frame: measured at or after 20 weeks gestation ]
    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

  16. Pre-eclampsia [ Time Frame: measured at or after 20 weeks gestation ]
    hypertension plus proteinuria or other organ involvement, neurologic or hematologic complications, uteroplacental dysfunction, or fetal growth restriction

  17. HELLP syndrome [ Time Frame: measured at or after 20 weeks gestation ]
    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)

  18. Gestational diabetes mellitus [ Time Frame: measured at or after 20 weeks gestation ]
    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]

  19. Prematurity [ Time Frame: at 24 weeks gestation, at 32 weeks gestation, at 34 weeks gestation, and at 37 weeks' gestation ]
    preterm birth if any

  20. Cumulative live birth [ Time Frame: at 12 months after randomization ]
    cumulative live birth delivery at 12 months after randomization



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02466204


Locations
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Vietnam
My Duc Hospital
Ho Chi Minh City, Vietnam, 70000
Research Center for Genetics and Reproductive Health
Ho Chi Minh City, Vietnam, 70000
Sponsors and Collaborators
Vietnam National University
Merck Sharp & Dohme Corp.
Mỹ Đức Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Manh Tuong Ho, Doctor, Vietnam National University
ClinicalTrials.gov Identifier: NCT02466204    
Other Study ID Numbers: NCKH/CGRH_ 01_2015
First Posted: June 9, 2015    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Infertility
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs