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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02466204
• Date of registration: 02/06/2015
• Prospective Registration: No
• Primary sponsor: Vietnam National University
• Public title: Efficacy of Corifollitropin Alfa Versus Follitropin Beta in Aged IVF (In-vitro Fertilization) Patients
• Scientific 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.
• Date of first enrolment: June 1, 2015
• Target sample size: 400
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02466204
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Vietnam

Key inclusion & exclusion 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).



Age minimum: 35 Years
Age maximum: 42 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Infertility

Intervention(s)

Drug: corifollitropin alfa

Drug: Follitropin Beta

Primary Outcome(s)

number of oocytes [Time Frame: 10 minutes after oocyte retrieval completed]

Secondary Outcome(s)

Pre-eclampsia [Time Frame: measured at or after 20 weeks gestation]

Clinical pregnancy [Time Frame: at 5 to 6 six weeks after embryo transfer]

Multiple pregnancy [Time Frame: at 7 weeks of gestation]

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

Cumulative live birth [Time Frame: at 12 months after randomization]

Ectopic pregnancy [Time Frame: 7 to 8 weeks after embryo transfer]

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

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

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

implantation rate [Time Frame: 5 to 6 weeks after embryo transfer]

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

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

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

Rate of moderate and severe ovarian hyperstimulation syndrome [Time Frame: 8 days after oocyte retrieval]

Miscarriage [Time Frame: 7 to 12 weeks of gestation]

number of MII oocytes [Time Frame: 2 hours after oocyte retrieval completed]

Ongoing pregnancy [Time Frame: at 10 weeks after embryo transfer]

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

number of 2PN [Time Frame: 18 hours after sperm injection]

Prematurity [Time Frame: at 24 weeks gestation, at 32 weeks gestation, at 34 weeks gestation, and at 37 weeks' gestation]

Secondary ID(s)

NCKH/CGRH_ 01_2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck Sharp & Dohme Corp.

M? Ð?c Hospital