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A Phase III Study to Compare Efficacy and Safety of AFOLIA vs. Gonal-f® in Infertile Women 35 to 42 Years of Age Undergoing in Vitro Fertilization (IVF)

Information source: Finox AG
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infertility

Intervention: Gonal-f (Drug); AFOLIA (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Finox AG

Official(s) and/or principal investigator(s):
Kevin Doody, MD, Principal Investigator, Affiliation: Center for Assisted Reproduction, Bedford, Texas

Summary

The purpose of this study is to show that AFOLIA, a recombinant manufactured human follicle stimulating hormone (r-hFSH) has a similar efficacy and safety profile compared to the widely used and marketed r-hFSH Gonal-f.

Clinical Details

Official title: A Phase III Investigator- and Assessor-blinded 1:1 Randomized, Parallel-group Multicenter Study to Compare Efficacy and Safety of Two r-hFSH Formulations (AFOLIA Pen vs. Gonal-f® RFF Pen) in Normal Ovulatory Women 35 to 42 Years of Age Undergoing in Vitro Fertilization (IVF)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Clinical pregnancy

Secondary outcome:

Immunogenicity

Local and systemic adverse events

Pregnancy outcome

Detailed description: Comparison of the clinical pregnancy rate in the AFOLIA group compared to the Gonal-f group as the primary endpoint. Comparison of the number and size of follicles, the number of cycle cancellation, the hormone parameters and adverse events in the AFOLIA group compared to the Gonal-f group as secondary endpoints.

Eligibility

Minimum age: 35 Years. Maximum age: 42 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- 35 to 42 years of age

- Indication for controlled ovarian stimulation and IVF or intracytoplasmic sperm

injection (ICSI)

- Regular menstrual cycles (25-35 days)

- History of a maximum of two fresh cycle treatments in the present series of assisted

reproductive technologies (ART) at the day of first screening (thawed cycles are not subject to that criteria)

- Body mass index (BMI) ≥18 and ≤38 kg/m2

- Basal FSH <12 IU/L (cycle day 2-5)

- Antral follicle count (AFC) ≥ 10 to ≤20 follicles with a diameter of <11mm (sum of

both ovaries) as measured on ultrasound (US) in the early follicular phase (menstrual cycle day 2-5)

- Documented history of infertility due to any of the following factors: tubal factor,

mild endometriosis (American Society for Reproductive Medicine [ASRM] stage 1-2), male factor, unexplained infertility

- Presence of both ovaries by ultrasonography and normal uterine cavity (confirmed by

hysterosalpingography, saline infusion sonography or hysteroscopy within 6 months before randomization)

- Male partner with semen analysis that is at least adequate for ICSI within 6 months

prior to patient beginning down-regulation (invasive or surgical sperm retrieval, donor and/or cryopreserved sperm may be used)

- Willingness to participate in the study and to comply with the study protocol

- Signed informed consent prior to screening

Exclusion Criteria:

- Presence of pregnancy

- History of or active polycystic ovary syndrome (PCOS)

- AFC >20 follicles with a diameter of <11 mm (both ovaries combined) as measured on US

in the early follicular phase (menstrual cycle day 2-5)

- History of >2 unsuccessful fresh ART retrieval cycles

- Presence of uncontrolled endocrine disorder

- Previous history or presence of severe OHSS

- Intrauterine fibroids ≥5 cm or otherwise clinically relevant pathology that could

impair embryo implantation or pregnancy continuation

- History of recurrent spontaneous abortion (3 or more, even when unexplained)

- Presence of severe endometriosis (ASRM stage 3 or stage 4) or hydrosalpinx

- Neoplasia, including tumors of the hypothalamus and pituitary gland

- Abnormal bleeding of undetermined origin

- History of extrauterine pregnancy in the previous 3 months

- Known allergy or hypersensitivity to progesterone or to any of the excipients

(including peanut oil) of the additional study medications (GnRH agonist, Ovidrel®, and Crinone 8%®)

- History of poor response to gonadotropin treatment (defined as fewer than 5 oocytes

retrieved in a previous attempt)

- Any hormonal treatment within 1 month before the start of the FSH treatment, with the

exception of levothyroxine)

- Egg donor

- Administration of other investigational products within the previous month

- Clinically abnormal findings at Visit 1

- Concomitant participation in another study protocol

Locations and Contacts

Physicians Research Group, Tempe, Arizona 85284, United States

HRC Fertility, Encino, California 91436, United States

Reproductive Associates of Delaware, Newark, Delaware 19713, United States

FL Fertility Institution, Tampa, Florida 33759, United States

Georgia Reproductive Specialists, Atlanta, Georgia 30342, United States

Fertility Centers of Illinois, Chicago, Illinois 60610, United States

In Via Fertility Specialists, Hoffman Estates, Illinois 60169, United States

Shady Grove Fertility RSC, Rockville, Maryland 20850, United States

Nevada Center for Reproductive Medicine, Reno, Nevada 89519, United States

Cooper Institute of Reproductive Hormonal Disorders, P.C., Marlton, New Jersey 08053, United States

Institute for Reproductive Health, Cincinnati, Ohio 45209, United States

Abington Reproductive Medicine, Abington, Pennsylvania 19001, United States

Main Line Fertility Center, Bryn Mawr, Pennsylvania 19010, United States

Shady Grove Fertility RSC, Chesterbrook, PA, Chesterbrook, Pennsylvania 19087, United States

University of Penn, Philadelphia, Pennsylvania 19104, United States

Fertility Associates of Memphis, Memphis, Tennessee 38120, United States

Texas Fertility Center, Austin, Texas 78731, United States

Center for Assisted Reproduction, Bedford, Texas 75022, United States

Fertility Specialists of Houston, Houston, Texas 77054, United States

Houston Fertility Institute, Houston, Texas 77063, United States

Center of Reproducitve Medicine, Webster, Texas 77598, United States

Jones Institute for Reproductive Medicine, Norfolk, Virginia 23507, United States

Additional Information

The IVY Study Website

Starting date: December 2013
Last updated: April 13, 2015

Page last updated: August 23, 2015

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