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Safety and Efficacy of Pre-defined, Fixed Dose of Gonal-f Pen Based on Subject Baseline Characteristics in Subjects Undergoing in Vitro Fertilization (IVF) (CONSORT)

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ClinicalTrials.gov Identifier: NCT00249834
Recruitment Status : Completed
First Posted : November 7, 2005
Results First Posted : March 30, 2018
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Tracking Information
First Submitted Date  ICMJE November 4, 2005
First Posted Date  ICMJE November 7, 2005
Results First Submitted Date  ICMJE August 29, 2017
Results First Posted Date  ICMJE March 30, 2018
Last Update Posted Date March 30, 2018
Actual Study Start Date  ICMJE September 22, 2004
Actual Primary Completion Date January 16, 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2017)
Number of Oocytes Retrieved [ Time Frame: Ovum pick up day (34 to 38 hours post r-hCG administration) ]
Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2017)
  • Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH) [ Time Frame: up to end of stimulation cycle (approximately 31 days) ]
    As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
  • Mean Number of Ovarian Stimulation Days [ Time Frame: up to end of stimulation cycle (approximately 31 days) ]
    The mean number of stimulation days were determined based on the treatment administration information collected in the case report form. Ovarian stimulation included time from first r-hFSH injection (stimulation Day) until day on which r-hCG was administered (r-hCG day). As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
  • Percentage of Cycles Cancelled Due to Excessive or Inadequate Response to r-hFSH [ Time Frame: up to end of stimulation cycle (approximately 31 days) ]
    As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
  • Number of Subjects Needing Dose Adjustment [ Time Frame: 6 days post r-hFSH treatment ]
    Number of subjects needing increase in dose, decrease in dose or increase and decrease both in dose were reported. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
  • Mean Daily Recombinant Human Follicle Stimulating Hormone (r-hFSH) Dose [ Time Frame: up to end of stimulation cycle (approximately 31 days) ]
    As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
  • Embryo Implantation Rate [ Time Frame: 35-42 days post r-hCG administration ]
    Embryo implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
  • Overall Pregnancy Rate, Clinical Rate and Multiple Pregnancy Rate [ Time Frame: 35-42 days post r-hCG administration ]
    Overall pregnancy rate was defined as the percentage of subjects with serum beta-hCG levels greater than 10 IU/L. Clinical pregnancy rate was defined as the percentage of subjects with at least 1 ultrasound confirmed gestational sac, with or without foetal heart activity. Multiple pregnancy rate was defined as the percentage of subjects with more than 1 ultrasound confirmed gestational sac in the uterus with fetal heart activity. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Pre-defined, Fixed Dose of Gonal-f Pen Based on Subject Baseline Characteristics in Subjects Undergoing in Vitro Fertilization (IVF)
Official Title  ICMJE A Phase IIIB/IV, Open Label Study to Assess the Efficacy and Safety of a Pre-defined, Fixed Dose of Gonal-f® (Filled-by-Mass in a Prefilled Pen) Based on Subject Baseline Characteristics, for Ovarian Stimulation in Subjects Undergoing in Vitro Fertilization (IVF)
Brief Summary Clinical validation of the assisted reproductive technology (ART) treatment guidelines, which determine the optimal dose of recombinant human follicle stimulating hormone (r-hFSH) based on subject baseline characteristics/predictors of ovarian response.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE
  • Drug: Gonal-f
    GONAL-f (follitropin alfa) will be administered subcutaneously based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle.
    Other Names:
    • follitropin alfa
    • Recombinant Human Follicle Stimulating Hormone (r-hFSH)
  • Drug: Recombinant human chorionic gonadotrophin (r-hCG)
    When at least 1 follicle greater than or equal to (>=) 18 millimeter (mm) and 2 follicles >=16 mm in diameter develop, 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) will be administered.
Study Arms  ICMJE
  • Experimental: Gonal-f 112.5 IU
    Interventions:
    • Drug: Gonal-f
    • Drug: Recombinant human chorionic gonadotrophin (r-hCG)
  • Experimental: Gonal-f 37.5 IU
    Interventions:
    • Drug: Gonal-f
    • Drug: Recombinant human chorionic gonadotrophin (r-hCG)
  • Experimental: Gonal-f 75 IU
    Interventions:
    • Drug: Gonal-f
    • Drug: Recombinant human chorionic gonadotrophin (r-hCG)
  • Experimental: Gonal-f 150 IU
    Interventions:
    • Drug: Gonal-f
    • Drug: Recombinant human chorionic gonadotrophin (r-hCG)
  • Experimental: Gonal-f 187.5 IU
    Interventions:
    • Drug: Gonal-f
    • Drug: Recombinant human chorionic gonadotrophin (r-hCG)
  • Experimental: Gonal-f 225 IU
    Interventions:
    • Drug: Gonal-f
    • Drug: Recombinant human chorionic gonadotrophin (r-hCG)
  • Experimental: Gonal-f 262.5 IU
    Interventions:
    • Drug: Gonal-f
    • Drug: Recombinant human chorionic gonadotrophin (r-hCG)
  • Experimental: Gonal-f 300 IU
    Interventions:
    • Drug: Gonal-f
    • Drug: Recombinant human chorionic gonadotrophin (r-hCG)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 29, 2017)
166
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 16, 2006
Actual Primary Completion Date January 16, 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Be an infertile subject justifying an in-vitro fertilization/embryo transfer (IVF/ET) treatment.
  • Have a male partner with semen analysis within the past six months prior to study entry considered adequate to proceed with regular insemination or intracytoplasmic sperm injection (ICSI) according to the center's standard practice. If these criteria are not met, the subject can only be entered if donor sperm will be used.
  • Be between her 18th and 35th birthday (35 not included).
  • Have a regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length.
  • Have early follicular phase (Day 2-4) serum levels within the last 3 months prior to study entry of:
  • Follicle stimulating hormone (FSH) greater than or equal to (>=) 12 International units per liter (IU/L), and
  • Oestradiol (E2) within center's local normal laboratory range values.
  • Presence of both ovaries.
  • Have a uterine cavity without abnormalities, which, in the investigator's opinion, could impair embryo implantation or pregnancy evolution as assessed within the last 3 years using ultrasound (US), hysteroscopy (HSC), or hysterosalpingography (HSG).
  • Have a negative cervical papanicolaou (PAP) test within the last 6 months prior to study entry.
  • Have at least one wash-out cycle (defined as >= 30 days since the last dose of clomiphene citrate or gonadotrophin treatment) since the last ART cycle and/or clomiphene citrate or gonadotrophin treatment prior to starting gonadotrophin releasing hormone (GnRH) agonist therapy.
  • Have a negative pregnancy test prior to beginning GnRH agonist therapy.
  • Be willing and able to comply with the protocol for the duration of the study. Have given written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to her future medical care.

Exclusion Criteria:

  • Had 2 previous ART cycles with a poor response to gonadotrophin stimulation, defined as less than or equal to (<=) 5 mature follicles and/or <=3 oocytes collected in any previous IVF cycle or hyper response, defined as >=25 oocytes retrieved.
  • Any medical condition, which in the judgement of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug. In case of doubt, the subject in question should be discussed with Serono's Therapeutic Director.
  • Had previous severe ovarian hyperstimulation syndrome (OHSS).
  • A body mass index (BMI) greater than (>) 30 kilogram per square meter (kg/m^2)
  • Any contraindication to being pregnant and/or carrying a pregnancy to term.
  • Extra-uterine pregnancy within the last 3 months.
  • History of 3 or more miscarriages (early or late miscarriages) due to any cause.
  • Tumours of the hypothalamus and pituitary gland.
  • Ovarian enlargement or cyst of unknown aetiology.
  • Ovarian, uterine or mammary cancer.
  • A clinically significant systemic disease.
  • Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus.
  • Abnormal gynaecological bleeding of undetermined origin.
  • Known allergy or hypersensitivity to human gonadotrophin preparations.
  • Any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years.
  • Entered previously into this study or simultaneous participation in another clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 34 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00249834
Other Study ID Numbers  ICMJE 25198
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck KGaA, Darmstadt, Germany
Study Sponsor  ICMJE Merck KGaA, Darmstadt, Germany
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Responsible Merck KGaA, Darmstadt, Germany
PRS Account Merck KGaA, Darmstadt, Germany
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP