Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00505752
Status:
COMPLETED
Last Update Posted:
2014-02-13
First Post:
2007-07-20
Brief Title:
Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology ART
Sponsor:
Merck KGaA Darmstadt Germany
Organization:
Merck KGaA Darmstadt Germany
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 2 interventional prospective multi-center randomized assessor-blind active-comparator dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone FSH in infertile women who are undergoing an assisted reproductive technology ART procedure In vitro fertilizationIntra cytoplasmic sperm injection IVFICSI This study will compare 3 doses of the investigational drug versus a currently marketed drug follitropin alfa Gonal-f revised formulation female RFF Pen in regards to the number of fertilized oocytes
Detailed Description:
Infertile women who are candidates for ART will be prospectively screened for enrollment at 24 clinical trial sites in the United States and Argentina Enrolled subjects will start treatment using oral contraceptives OCP and will then receive a Gonadotropin releasing hormone GnRH-agonist leuprolide acetate for pituitary desensitization Once down-regulation is achieved the subjects will be randomized in a 1111 ratio to begin ovarian stimulation with one of 3 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 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 and E2 levels On S6 subjects randomized to AS900672-Enriched may begin receiving supplemental follitropin alfa 150 IU according to the each subjects 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 ovarian hyperstimulation syndrome OHSS Oocyte retrieval will occur within 34-38 hours after r-hCG administration and subjects will begin luteal phase support using vaginal progesterone Crinone 8 percent or Prochieve 8 percent the following day Fertilization will be done by conventional IVF or ICSI Embryo transfer will occur in accordance with the specific requirements of each subject and the clinical trial sites 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 r-hCG administration Subjects with a positive pregnancy test will undergo a confirmatory ultrasound evaluation at Day 35 - 42 post r-hCG Additionally all subjects recruited at certain trial centers will participate in a pharmacokinetic PK sub-study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None