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Sponsored by: |
EMD Serono |
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Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00505752 |
Study to evaluate a new investigational long-acting follicle stimulating hormone in infertile women who are undergoing an assisted reproductive technology procedure (IVF/ICSI). This study will compare three doses of the investigational drug vs a currently marketed medication (Gonal-f® RFF Pen) in regards to the number of fertilized eggs.
Condition | Intervention | Phase |
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Infertility |
Drug: AS900672-Enriched Drug: Gonal-f RFF® |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Multicenter, Randomized, Assessor-Blinded, Active-Comparator, Dose-Finding Study to Evaluate AS900672 Enriched Versus Follitropin Alfa (Gonal-f®) in Stimulating Multiple Follicular Development in Infertile Women Undergoing Assisted Reproductive Technology (ART) |
Estimated Enrollment: | 516 |
Study Start Date: | July 2007 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
AS900672-Enriched 50 mcg in a single subcutaneous injection. Daily supplemental Gonal-f® subcutaneous injections (max dose of 150 IU)will be allowed to begin after 5 days if needed as determined by the Investigator. These will continue until oocyte retrieval or a max of 21 days.
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Drug: AS900672-Enriched
Arms 1-3 will receive AS900672-Enriched in a single sc injection of either 50, 100, or 150 mcg. Daily supplemental Gonal-f® subcutaneous injections (max dose of 150 IU)will be allowed to begin after 5 days if needed as determined by the Investigator. These will continue until oocyte retrieval or a max of 21 days.
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2: Experimental
AS900672-Enriched 100 mcg in a single subcutaneous injection. Daily supplemental Gonal-f® subcutaneous injections (max dose of 150 IU) will be allowed to begin after 5 days if needed as determined by the Investigator. These will continue until oocyte retrieval or a max of 21 days.
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Drug: AS900672-Enriched
Arms 1-3 will receive AS900672-Enriched in a single sc injection of either 50, 100, or 150 mcg. Daily supplemental Gonal-f® subcutaneous injections (max dose of 150 IU)will be allowed to begin after 5 days if needed as determined by the Investigator. These will continue until oocyte retrieval or a max of 21 days.
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3: Experimental
AS900672-Enriched 150 mcg in a single subcutaneous injection. Daily supplemental Gonal-f® subcutaneous injections (max dose of 150 IU) will be allowed to begin after 5 days if needed as determined by the Investigator. These will continue until oocyte retrieval or a max of 21 days.
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Drug: AS900672-Enriched
Arms 1-3 will receive AS900672-Enriched in a single sc injection of either 50, 100, or 150 mcg. Daily supplemental Gonal-f® subcutaneous injections (max dose of 150 IU)will be allowed to begin after 5 days if needed as determined by the Investigator. These will continue until oocyte retrieval or a max of 21 days.
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4: Active Comparator
Daily supplemental Gonal-f® subcutaneous injections (max 150 IU). These will continue until oocyte retrieval or a max of 21 days.
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Drug: Gonal-f RFF®
Arm 4 will receive daily Gonal-f RFF® (max 150 IU). These will continue until oocyte retrieval or a max of 21 days
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Infertile women who are candidates for ART will be prospectively screened for enrollment at approximately 26 clinical trial sites in the United States, Chile and Argentina. Enrolled subjects will start treatment using oral contraceptives (OCP) and will then receive a GnRH-agonist (leuprolide acetate) for pituitary desensitization. Once down-regulation is achieved, the subjects will be randomized in a 1:1:1:1 ratio to begin ovarian stimulation with one of three doses of AS900672 Enriched or with follitropin alfa (Gonal-f®) daily injections. Subjects will be recruited to the four study arms in parallel. Beginning on stimulation day 1 (S1), the subjects will receive either a single injection of AS900672 Enriched or start daily injections of follitropin alfa. The subjects' response to treatment will be monitored by ovarian ultrasound (US) and estradiol (E2) levels. On stimulation day 6 (S6), subjects randomized to AS900672 Enriched may begin receiving supplemental follitropin alfa 150 IU, according to the each subject's ovarian response, and subjects randomized to follitropin alfa 150 IU daily injections will continue treatment at the same dose. Recombinant human chorionic gonadotropin (r hCG, Ovidrel®) will be administered to subjects meeting response criteria and who are not at risk for OHSS. Oocyte retrieval will occur within 34-38 hours after hCG administration and subjects will begin luteal phase support using vaginal progesterone (Crinone 8%® or Prochieve ® 8%) the following day. Fertilization will be done by conventional in vitro fertilization (IVF) or intra-cytoplasmic sperm injection (ICSI). Embryo transfer will occur in accordance with the specific requirements of each subject and the clinical trial site's standard practice, with the exception that a maximum of two embryos at the cleavage or blastocyst stage may be transferred. Subjects who undergo embryo transfer will be assessed for pregnancy and a follow-up visit will be performed 15-20 days post hCG administration. Subjects with a positive pregnancy test will undergo a confirmatory ultrasound evaluation at day 35 - 42 post hCG. Additionally, all subjects recruited at certain trial centers will participate in a pharmacokinetic (PK) sub-study..
Ages Eligible for Study: | 18 Years to 36 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | EMD Serono, Inc ( George Hemsey, Senior Clinical Project Manager ) |
Study ID Numbers: | 27591 |
Study First Received: | July 20, 2007 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00505752 |
Health Authority: | United States: Food and Drug Administration |
Assisted reproductive technology, follicle stimulating hormone |
Genital Diseases, Female Signs and Symptoms Infertility Genital Diseases, Male Follicle Stimulating Hormone |
Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions |