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Trial · Interventional

CompletedPhase 4Registry data

A Study to Compare the Safety and Efficacy of Cetrotide® 3 Milligram (mg) Versus Antagon™ in Women Undergoing Ovarian Stimulation

Overview

Status
Completed
Phase
Phase 4
Enrollment
185 participants (actual)
Sponsor
EMD Serono · Industry
Design
Randomized · Open label (no masking)
Countries
Not stated
Start
Sept 2003
Primary completion
May 2004
Completion
May 2004
First posted
1 Mar 2006 (estimated)
Last update posted
26 Mar 2014 (estimated)
Conditions
Infertile Women Undergoing Assisted Reproductive Technology (ART)

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200320042005
  1. Ph 4

    A Study to Compare the Safety and Efficacy of Cetrotide® 3 Milligram (mg) Versus Antagon™ in Women Undergoing Ovarian Stimulation

    NCT00298025

    Sept 2003 to May 2004

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

To demonstrate the comparative safety and efficacy of Cetrotide® 3 milligram (mg) and Antagon™ in the inhibition of a premature luteinizing hormone (LH) surge in women undergoing ovarian stimulation with recombinant human follicle stimulating hormone/human menopausal gonadotropin (r-hFSH/hMG) prior to assisted reproductive technology (ART) and utilizing oral contraceptives pill (OCP) for cycle programming.

Interventions

  • Cetrotide®Drug
  • Antagon ™Drug
  • Recombinant human follicle stimulating hormone (r-hFSH)Drug
  • Human Menopausal Gonadotropin (hMG)Drug
  • Recombinant Human Choriogonadotropin (r-hCG)Drug

Arms2

  • Experimental

    Cetrotide®

  • Active comparator

    Antagon ™

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of subjects without premature luteinizing hormone (LH) surge

    Time frame · r-hCG administration day (end of stimulation cycle {approximately 4 days})

Secondary outcomes(12)
  1. Duration of study treatment

    Time frame · Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle {approximately 4 days})

  2. Total dose of recombinant human follicle stimulating hormone/human menopausal gonadotropin (r-hFSH/hMG) administered

    Time frame · Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle {approximately 4 days})

  3. Duration of gonadotropin therapy

    Time frame · Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle {approximately 4 days})

  4. Number of follicles greater than or equal to (>=) 14 millimeter (mm) on day of recombinant human chorionic gonadotropin (r-hCG) administration

    Time frame · r-hCG administration day (end of stimulation cycle {approximately 4 days})

  5. Number of oocytes retrieved

    Time frame · Ovum pick-up (OPU) day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 4 days}])

  6. Number of mature oocytes retrieved

    Time frame · OPU day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 4 days}])

  7. Number of fertilized oocytes

    Time frame · Day 1 post OPU day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 4 days}])

  8. Number and Quality of Embryos

    Time frame · Day 2-3 post OPU (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 4 days}])

  9. Implantation rate

    Time frame · Day 35-42 post r-hCG administration day (end of stimulation cycle {approximately 4 days})

  10. Total number of transferred and cryopreserved embryos

    Time frame · Day 2-3 post OPU (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 4 days}])

  11. Percentage of subjects with clinical and biochemical pregnancies

    Time frame · Day 35-42 post r-hCG administration day (end of stimulation cycle {approximately 4 days})

  12. Quality of Life assessed by Short Form- 36 (SF-36) Questionnaire

    Time frame · Stimulation Day 1 (S1) and Day 15-18 post r-hCG administration (end of stimulation cycle {approximately 4 days})

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2005

8 results

Prospective, randomized trial comparing cetrorelix acetate and ganirelix acetate in a programmed, flexible protocol for premature luteinizing hormone surge prevention in assisted reproductive technologies.

Wilcox et al. 2005Fertility and sterilitycited by 33

PMID 16009165DOI 10.1016/j.fertnstert.2005.03.016PUB-16009165

Full text at the publisher8 results

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 39 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Infertile women wishing to conceive whose physician had recommended that she can undergo ART * Aged 18-39 years (inclusive) * Regular menstrual cycles every 25-35 days * Body mass index (BMI) less than 35 kilogram per square meter (kg/m\^2) * Has a transvaginal pelvic ultrasound scan within 6 weeks prior to OCP administration, as well as an Hysterosalpingography (HSG) or hysterosonogram or hysteroscopy within three years prior to OCP administration showing no clinically significant pelvic and/or uterine abnormality, which, in the Investigator's opinion, could impair ovarian response, embryo implantation or pregnancy continuation * Normal cervical cytology, documented by Pap Smear, within six months prior to OCP administration * If the subject had prior stimulation cycles, at least a 60-day washout period is required after the last dose of gonadotropin or clomiphene citrate; a 60-day washout is required after the last dose of Lupron® or Lupron Depot® 1-month; a 180-day washout period is required after the last dose of treatment with Depo-Provera® and Lupron Depot® 6-month; a 60-day washout is required after the last dose of oral contraceptives prior to OCP administration in the study * Screening laboratory results for follicle stimulating hormone (FSH) that are within the normal limit for the early follicular phase at the local laboratory * Is willing and able to comply with the protocol for the duration of the study * Has voluntarily provided written informed consent and a subject authorization under Health insurance portability and accountability act (HIPAA), prior to any study-related procedure that is not part of normal medical care, with the understanding that the subject could withdraw consent at any time without prejudice to her future medical care Exclusion Criteria: * Clinically significant systemic disease * Known to be infected with Human Immunodeficiency Virus (HIV) * Known to be infected with Hepatitis C virus * Known to test positive for Hepatitis B surface antigens * Any medical condition, which, in the judgment of the Investigator and Sponsor, may interfere with the absorption, distribution, metabolism or excretion of the study drugs * Known endometriosis Grade III-IV (American society of reproductive medicine \[ASRM\] classification) * Uni- or bilateral hydrosalpinx * Any contraindication to being pregnant and/or carrying pregnancy to term * Any previous ART cycle indicating a poor response to gonadotropin stimulation (defined as retrieval of three oocytes or less) * If, in a previous ART attempt, there are no motile sperm before or after the sperm processing with ejaculated, epididymal, testicular, fresh or frozen/thawed spermatozoa * Three or more previous consecutive ART cycles without a clinical pregnancy * An extrauterine pregnancy within the last three months before OCP treatment commences * Abnormal, undiagnosed, gynecological bleeding * Known allergy or hypersensitivity to human gonadotropin preparations or any other study-related medications * Known current substance abuse * Previous participation in this study or simultaneous participation in another clinical trial * Current smoker

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