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Org 36286 in Patients Undergoing Repeated Controlled Ovarian Stimulation Cycles Using a Multiple Dose GnRH Antagonist Protocol (Study 38825)(P05714)(COMPLETED) (Trust)
This study has been completed.

First Received on June 11, 2008.   Last Updated on October 2, 2009   History of Changes
Sponsor: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00696878
  Purpose

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.


Condition Intervention Phase
In Vitro Fertilization
 Drug: Org 36286, corifollitropin alfa
 Phase III

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Drug Information available for: Gonadorelin Gonadorelin hydrochloride Corifollitropin alfa LH-RH
U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 681
Study Start Date: September 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
150 µg single dose Org 36286; Any FSH preparation (max 225 IU/day); Any GnRH antagonist (0.25 mg/day); Any (rec)hCG preparation (5,000-10,000 IU/250 µg); Progesterone at least 600 mg/day vaginally
 Drug: Org 36286, corifollitropin alfa

A single dose of 150 µg Org 36286 will be administered subcutaneously on day 2-3 of the menstrual cycle. Self-administration of Org 36286 is preferred and subcutaneous injections should be given in the abdominal wall, in the morning.

Administration of the GnRH antagonist will start on stimulation day 5 or 6. From stimulation day 8 onwards, treatment is continued with a daily dose of any commercially available FSH-containing preparation up to the day of (rec)hCG administration. Administration of the FSH-containing preparation on the day of hCG is optional. The investigator may withhold gonadotropin administration for a maximum of 3 days (coasting) up to and including the day of (rec)hCG administration. The maximum total duration of stimulation is 19 days.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by Schering-Plough

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Norman RJ, Zegers-Hochschild F, Salle BS, Elbers J, Heijnen E, Marintcheva-Petrova M, Mannaerts B; Trust Investigators. Repeated ovarian stimulation with corifollitropin alfa in patients in a GnRH antagonist protocol: no concern for immunogenicity. Hum Reprod. 2011 Aug;26(8):2200-8. Epub 2011 May 27.

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00696878     History of Changes
Other Study ID Numbers: 38825, P05714
Study First Received: June 11, 2008
Last Updated: October 2, 2009
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica;   Australia: Department of Health and Ageing Therapeutic Goods Administration;   Brazil: National Health Surveillance Agency;   Chile: Instituto de Salud Publica de Chile;   Denmark: Danish Medicines Agency;   France: Afssaps - French Health Products Safety Agency;   Germany: German Institute of Medical Documentation and Information;   Hungary: National Institute of Pharmacy;   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO);   Norway: Norwegian Medicines Agency;   Sweden: Medical Products Agency

Keywords provided by Schering-Plough:
Infertility
Pharmacological effects of drugs
Hormones, Hormone Substitutes and Hormone Antagonists
Pharmacological Actions
Multi-center

ClinicalTrials.gov processed this record on February 12, 2012



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