To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Engage)(Study 38819AM1)(COMPLETED)(P05787)
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Purpose
To investigate the efficacy and safety of a single injection of 150 μg Org 36286 to induce multifollicular development for controlled ovarian stimulation using daily recombinant FSH as a reference.
| Condition | Intervention | Phase |
|---|---|---|
|
In Vitro Fertilization |
Drug: corifollitropin alfa Drug: follitropin beta |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase III, Non-Inferiority Clinical Trial to Investigate the Efficacy and Safety of a Single Injection of 150 µg Org 36286 (Corifollitropin Alfa) to Induce Multifollicular Development for Ovarian Stimulation Using Daily Recombinant FSH as Reference |
- Ongoing pregnancy rate [ Time Frame: Assessed at least 10 weeks after embryo transfer ] [ Designated as safety issue: No ]
- Number of oocytes retrieved [ Time Frame: One Controlled Ovarian Stimulation (COS) cycle ] [ Designated as safety issue: No ]
- Amount of recombinant FSH needed [ Time Frame: Total and from Day 8 to Day of hCG ] [ Designated as safety issue: No ]
- Endocrinological parameters (FSH, LH, E2, P, inhibin-B) [ Time Frame: One Controlled Ovarian Stimulation (COS) cycle ] [ Designated as safety issue: No ]
- Number and size distribution of follicles as documented by ultrasonography [ Time Frame: during treatment and on the Day of hCG ] [ Designated as safety issue: No ]
- Number and quality of oocytes [ Time Frame: One Controlled Ovarian Stimulation (COS) cycle ] [ Designated as safety issue: No ]
- Fertilization rate [ Time Frame: One Controlled Ovarian Stimulation (COS) cycle ] [ Designated as safety issue: No ]
- Number and quality of embryos [ Time Frame: One Controlled Ovarian Stimulation (COS) cycle ] [ Designated as safety issue: No ]
- Implantation rate [ Time Frame: One Controlled Ovarian Stimulation (COS) cycle ] [ Designated as safety issue: No ]
- Miscarriage rate [ Time Frame: One Controlled Ovarian Stimulation (COS) cycle ] [ Designated as safety issue: No ]
- Pregnancy rate [ Time Frame: One Controlled Ovarian Stimulation (COS) cycle ] [ Designated as safety issue: No ]
| Enrollment: | 1509 |
| Study Start Date: | July 2006 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
150 µg Org 36286 (corifollitropin alfa)
|
Drug: corifollitropin alfa
On day 2 or 3 of the menstrual cycle, a single SC injection of 150 μg (0.5 mL) Org 36286 will be administered (Stimulation Day 1). Daily SC injections with placebo-recFSH (equivalent of 200 IU fixed dose) will be started on Stimulation Day 1 and continued up to and including Stimulation Day 7. From Stimulation Day 8 onwards treatment is continued with a daily SC dose of recFSH up to and including the Day of hCG. The maximum total duration of stimulation is 19 days. Other Name: Org 36286
|
|
Active Comparator: Arm 2
200 IU recFSH (follitropin beta)
|
Drug: follitropin beta
On day 2 or 3 of the menstrual cycle, a single SC injection of 0.5 mL placebo-Org 36286 will be administered (Stimulation Day 1). Daily SC injections with recFSH (200 IU fixed dose) will be started on Stimulation Day 1 and continued up to and including Stimulation Day 7. From Stimulation Day 8 onwards treatment is continued with a daily SC dose of recFSH up to and including the Day of hCG. The maximum total duration of stimulation is 19 days. Other Name: recFSH (Puregon / Follistim AQ Cartridge)
|
Detailed Description:
This is a randomized, double-blind, active-controlled, non-inferiority clinical trial investigating the efficacy and safety of a new treatment regimen with Org 36286, a recombinant gonadotropin applied to initiate and sustain follicular stimulation in controlled ovarian stimulation for ART. For this regimen, patients receive a single injection of Org 36286 and one week later, treatment is continued with daily recFSH up to the day of triggering final oocyte maturation. In the reference group patients receive daily injections of recFSH up to the day of triggering final oocyte maturation. Non-inferiority in ongoing pregnancy rates (assessed at least 10 weeks after embryo transfer) will be the primary endpoint for this trial. The number of oocytes retrieved will be analyzed as co-primary endpoint.
Eligibility| Ages Eligible for Study: | 18 Years to 36 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Females of couples with an indication for COS and IVF or ICSI;
- >=18 and <=36 years of age at the time of signing informed consent;
- Body weight > 60 and <=90 kg and BMI >=18 and <=32 kg/m^2;
- Normal menstrual cycle length: 24-35 days;
- Availability of ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed);
- Willing and able to sign informed consent.
Exclusion Criteria:
- History of/or any current (treated) endocrine abnormality;
- History of ovarian hyper-response or ovarian hyperstimulation syndrome (OHSS);
- History of/or current polycystic ovary syndrome (PCOS);
- More than 20 basal antral follicles <11 mm (both ovaries combined) as measured on USS in the early follicular phase (menstrual cycle day 2-5);
- Less than 2 ovaries or any other ovarian abnormality (including endometrioma > 10 mm; visible on USS);
- Presence of unilateral or bilateral hydrosalphinx (visible on USS);
- Presence of any clinically relevant pathology affecting the uterine cavity or fibroids >=5 cm;
- More than three unsuccessful IVF cycles since the last established ongoing pregnancy (if applicable);
- History of non- or low ovarian response to FSH/hMG treatment;
- History of recurrent miscarriage (3 or more, even when unexplained);
- FSH > 12 IU/L or LH > 12 IU/L as measured by the local laboratory (sample taken during the early follicular phase: menstrual cycle day 2-5);
- Any clinically relevant abnormal laboratory value based on a sample taken during the screening phase;
- Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts);
- Recent history of/or current epilepsy, HIV infection, diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary disease;
- Abnormal karyotyping of the patient or her partner (if karyotyping is performed);
- Smoking more than 5 cigarettes per day;
- History or presence of alcohol or drug abuse within 12 months prior to signing informed consent;
- Previous use of Org 36286;
- Use of hormonal preparations within 1 month prior to randomization;
- Hypersensitivity to any of the concomitant medication prescribed as part of the treatment regimen in this protocol;
- Administration of investigational drugs within three months prior to signing informed consent.
Contacts and Locations More Information
No publications provided by Schering-Plough
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00696800 History of Changes |
| Other Study ID Numbers: | 38819, EudraCT #: 2004-004771-11;, P05787 |
| Study First Received: | June 11, 2008 |
| Last Updated: | October 2, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Schering-Plough:
|
Infertility Pharmacological effect of drugs Hormones Hormone substitutes and hormone antagonists Pharmacological actions Randomized |
Multi-center Multi-national Double-blind Active-controlled Non-inferiority |
Additional relevant MeSH terms:
|
Follicle Stimulating Hormone Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013