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

NCT02466204 | Completed Phase 4

• 1 other identifier: NCKH/CGRH_ 01_2015
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Rate of moderate and severe ovarian hyperstimulation syndrome

  8 days after oocyte retrieval

• Live birth

  at the time of delivery

• number of MII oocytes

  2 hours after oocyte retrieval completed

• number of 2PN

  18 hours after sperm injection

• number of mature follicles >11 mm

  on the day of hCG administration

Study Arms (2)

corifollitropin alfa (long action FSH)

ACTIVE COMPARATOR

corifollitropin alfa 150 mcg subcutaneous injection. Seven days after, combines with recombinant FSH 300 IU daily subcutaneous injection

Drug: corifollitropin alfa

Follitropin Beta (recombinant FSH)

ACTIVE COMPARATOR

300 IU of recombinant FSH, daily subcutaneous injection

Drug: Follitropin Beta

Interventions

corifollitropin alfa DRUG

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

corifollitropin alfa (long action FSH)

Follitropin Beta DRUG

Drug is injected subcutaneously, daily, until at least two leading ovarian follicles reach 17mm in diameter.

Also known as: Puregon

Follitropin Beta (recombinant FSH)

Eligibility Criteria

• Age: 35 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vietnam National University: lead
• Merck Sharp & Dohme LLC: collaborator
• Mỹ Đức Hospital: collaborator

Study Sites (2)

My Duc Hospital

Ho Chi Minh City, 70000, Vietnam

Location

Research Center for Genetics and Reproductive Health

Ho Chi Minh City, 70000, Vietnam

Location

Related Publications (1)

• Vuong NL, Pham DT, Phung HT, Giang HN, Huynh GB, Nguyen TTL, Ho MT. Corifollitropin alfa vs recombinant FSH for controlled ovarian stimulation in women aged 35-42 years with a body weight >/=50 kg: a randomized controlled trial. Hum Reprod Open. 2017 Nov 28;2017(3):hox023. doi: 10.1093/hropen/hox023. eCollection 2017.

  PMID: 30895237 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

follicle stimulating hormone, human, with HCG C-terminal peptide; follitropin beta

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 9, 2015
• Study Start: June 1, 2015
• Primary Completion: August 10, 2016
• Study Completion: August 15, 2017
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

VN (2)