Investigate Dose of Org 36286 to Initiate Multiple Follicular Growth in a Controlled Ovarian Hyperstimulation Protocol for IVF or IVF/ICSI (Study 38807)(COMPLETED)
Summary
The primary objective of this trial was to investigate the appropriate dose of a single injection of Org 36286 to initiate multifollicular growth for the first seven days in a controlled ovarian hyperstimulation (COH) protocol for IVF and IVF/ICSI. After seven days, patients were converted to treatment with 150 IU Puregon® and administration of the GnRH antagonist Orgalutran® to finalize the stimulation cycle. Secondary objectives were the safety (including the absence of antibody formation) and the direct effects of Org 36286 on reproductive functions (steroidogenesis, oocyte maturation, embryo quality and implantation).
Description
This trial was made up of two stages with different designs and was conducted in two clinical trial sites.
Stage I was open-label and uncontrolled in a small cohort of women (n=6) to obtain first experience in employing Org 36286 in women meeting all inclusion and none of the exclusion criteria. Based on the results of a previous study, the most appropriate dose was anticipated to be 120 μg Org 36286, which was administered on Cycle Day 2 or 3. After seven days, treatment was continued with a fixed dose of 150 IU Puregon® SC. If the size of the leading follicle was >=14 mm, 0.25 mg Orgalutran® SC once daily was administered concurrently with 150 IU Puregon® up to and including the day of hCG. The maximum total treatment duration was 19 days. Treatment of the first two subjects with 120 μg Org 36286, that was expected to be adequate for COH, was cancelled due to disrupted follicular growth beyond Day 7. Therefore, the dose of Org 36286 was adapted from 120 μg to 180 µg as per amendment II. Treatment of the first subjects gave an indication of the validity of the anticipated doses to be used in Stage II, the actual dose-finding trial.
Stage II was open-label, prospective and randomized, comparing three experimental regimens differing in dose of Org 36286 (120 μg, 180 μg, or 240 μg) with a reference treatment.
Post-treatment assessments were completed at the visit two weeks after embryo transfer.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Infertility
Intervention
Corifollitropin Alfa, Puregon®, Orgalutran®
Status
Completed
Source
Schering-Plough
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00702806
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Interferon Alfa-2c
A recombinant alfa interferon consisting of 165 amino acids with arginine at positions 23 and 34. It is used extensively as an antiviral and antineoplastic agent.
Interferon Alfa-2a
A recombinant alfa interferon consisting of 165 amino acids with lysine at position 23 and histidine at position 34. It is used extensively as an antiviral and antineoplastic agent.
Interferon Alfa-2b
A recombinant alfa interferon consisting of 165 amino acid residues with arginine in position 23 and histidine in position 34. It is used extensively as an antiviral and antineoplastic agent.
Epoetin Alfa
This recombinant erythropoietin, a 165-amino acid glycoprotein (about 62% protein and 38% carbohydrate), regulates red blood cell production. Epoetin alfa is produced by Chinese hamster ovary cells into which the human erythropoietin gene has been inserted. (USP Dictionary of USAN and International Drug Names, 1996).
Infertility
Inability to reproduce after a specified period of unprotected intercourse. Reproductive sterility is permanent infertility.
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