| Org 36286 in Patients Undergoing Repeated Controlled Ovarian Stimulation Cycles Using a Multiple Dose GnRH Antagonist Protocol |
| A Phase III, Uncontrolled Trial to Assess the Non-Immunogenicity and Safety of Org 36286 in Patients Undergoing Repeated Controlled Ovarian Stimulation Cycles Using a Multiple Dose GnRH Antagonist Protocol (Study 38825) |
The objective of the trial is to assess the non-immunogenicity and safety of Org 36286 in patients undergoing repeated Controlled Ovarian Stimulation (COS) cycles using a multiple dose GnRH antagonist protocol. |
This trial is designed as an open-label, uncontrolled, repeated cycle trial to assess the non-immunogenicity and safety of Org 36286 in patients undergoing repeated controlled ovarian stimulation (COS) cycles for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) using a multiple dose GnRH antagonist protocol. The trial period per subject will cover 1, 2 or 3 treatment cycles and no more than three (in-between two stimulation cycles) Frozen-Thawed Embryo Transfer (FTET) cycles from the first two treatment cycles. In each stimulation cycle, patients receive a single injection of Org 36286 and one week later, treatment is continued with a daily dose of any FSH-containing preparation up to the day of (rec)hCG administration for final oocyte maturation. Assessment of anti-Org 36286 antibodies and local tolerance after Org 36286 injection are important safety endpoints in this trial. |
| Phase III |
| Interventional |
| Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Main safety parameters: anti-Org 36286 antibodies, local tolerance, occurrence of (S)AEs and occurrence of moderate to severe OHSS. [ Time Frame: A maximum of 3 COS cycles. ] [ Designated as safety issue: Yes ] |
Amount of (rec)FSH needed from stimulation day 8 onwards to reach the criterion for administration of (rec)hCG [ Time Frame: A maximum of 3 COS cycles. ] [ Designated as safety issue: No ]
Number and size distribution of follicles (>= 11 mm, >= 15 mm, and >= 17 mm) as
documented by ultrasonography from stimulation day 1 up to and including the
day of (rec)hCG administration; Number and quality of oocytes retrieved [ Time Frame: A maximum of 3 COS cycles. ] [ Designated as safety issue: No ]
Number of fertilized oocytes obtained, frozen and used for embryo development; Fertilization rate, defined as the ratio of the number of fertilized 2PN oocytes obtained and the number of oocytes incubated (IVF or ICSI) [ Time Frame: A maximum of 3 COS cycles. ] [ Designated as safety issue: No ]
Implantation rate for subjects with ET (defined as 100 times the number of
gestational sacs as assessed by the first USS after ET divided by the number of
embryos transferred for each subject) [ Time Frame: A maximum of 3 COS cycles. ] [ Designated as safety issue: No ]
Biochemical pregnancy, ectopic pregnancy, clinical pregnancy, vital pregnancy,
(singleton and multiple) ongoing pregnancy and miscarriage; Outcome of FTET cycles; Cumulative ongoing pregnancy rate. [ Time Frame: A maximum of 3 COS cycles. ] [ Designated as safety issue: No ]
Number and quality of embryos obtained, transferred and frozen [ Time Frame: A maximum of 3 COS cycles. ] [ Designated as safety issue: No ]
Endocrinological parameters (FSH, LH, E2, P, inhibin-B) as determined by central lab, during stimulation and including the day of (rec)hCG administration, at embryo transfer and 2 weeks after embryo transfer [ Time Frame: A maximum of 3 COS cycles. ] [ Designated as safety issue: No ] |
| In Vitro Fertilization |
| Drug: Org 36286, corifollitropin alfa |
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|
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| Active, not recruiting |
| 681 |
| September 2006 |
| July 2009 |
Inclusion Criteria:
- Females of couples with an indication for COS and IVF or ICSI;
- >=18 and <=39 years of age at the time of signing informed consent;
- Body weight > 60 kg and BMI >=18 and <=29 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 history of ovarian hyperstimulation syndrome (OHSS);
- History of or current polycystic ovary syndrome (PCOS);
- More than 20 basal antral follicles (size: <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 hydrosalpinx (visible on USS);
- More than three unsuccessful COS cycles since the last established ongoing pregnancy (if applicable);
- History of non- or low ovarian response to FSH/hMG treatment;
- 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 (including abnormal cervical smear (PAP>=III, CIN>=1));
- Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts) or GnRH antagonists (e.g. hypersensitivity, pregnancy/lactation);
- Recent history of or current epilepsy, HIV infection, thrombophilia, diabetes or cardiovascular, gastro-intestinal, hepatic, renal, or pulmonary disease;
- Abnormal karyotyping of the patient or her partner (if karyotyping is performed);
- 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 screening;
- Administration of investigational drugs within three months prior to signing informed consent.
|
| Female |
| 18 Years to 39 Years |
| No |
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| NCT00696878 |
| 38825 |
| P05714 |
| Organon |
|
|
| Organon |
| November 2008 |
| June 11, 2008 |
| November 24, 2008 |
