![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date † | July 20, 2007 | ||||
Last Updated Date | March 21, 2009 | ||||
Start Date † | July 2007 | ||||
Current Primary Outcome Measures † |
Number of fertilized oocytes. [ Time Frame: 1 day after egg retrieval and fertilization. ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00505752 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Clinical Pregnancy data 3 weeks after the embryo transfer [ Time Frame: 3 weeks ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Investigation of a Long Acting Follicle Stimulating Hormone in Women Undergoing Assisted Reproductive Technology (ART) | ||||
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) | ||||
Brief Summary | 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. |
||||
Detailed Description | 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.. |
||||
Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Infertility | ||||
Intervention † |
|
||||
Study Arms / Comparison Groups |
|
||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Enrollment † | 516 | ||||
Completion Date | |||||
Estimated Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||
Gender | Female | ||||
Ages | 18 Years to 36 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00505752 | ||||
Responsible Party | George Hemsey, Senior Clinical Project Manager, EMD Serono, Inc | ||||
Secondary IDs †† | |||||
Study Sponsor † | EMD Serono | ||||
Collaborators †† | |||||
Investigators † |
|
||||
Information Provided By | EMD Serono | ||||
Verification Date | March 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |