NCT00298025

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2003

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2006

Completed
Last Updated

March 26, 2014

Status Verified

March 1, 2014

Enrollment Period

8 months

First QC Date

February 27, 2006

Last Update Submit

March 24, 2014

Conditions

Infertile Women Undergoing Assisted Reproductive Technology (ART)

Keywords

InfertilityCetrotideAntagonRecombinant human follicle stimulating hormone (r-hFSH)Human Menopausal Gonadotropin (hMG)Recombinant Human Choriogonadotropin (r-hCG)

Outcome Measures

Primary Outcomes (1)

  • Percentage of subjects without premature luteinizing hormone (LH) surge

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

Secondary Outcomes (12)

  • Duration of study treatment

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

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

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

  • Duration of gonadotropin therapy

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

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

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

  • Number of oocytes retrieved

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

  • +7 more secondary outcomes

Study Arms (2)

Cetrotide®

EXPERIMENTAL
Drug: Cetrotide®Drug: Recombinant human follicle stimulating hormone (r-hFSH)Drug: Human Menopausal Gonadotropin (hMG)Drug: Recombinant Human Choriogonadotropin (r-hCG)

Antagon ™

ACTIVE COMPARATOR
Drug: Antagon ™Drug: Recombinant human follicle stimulating hormone (r-hFSH)Drug: Human Menopausal Gonadotropin (hMG)Drug: Recombinant Human Choriogonadotropin (r-hCG)

Interventions

Cetrotide®DRUG

Cetrotide® will be administered subcutaneously as 3 mg injection when the lead follicle is \>=14 mm till r-hCG day. If the subject did not achieve follicular maturation and did not receive r-hCG within 4 days, then the Cetrotide® will be administered at dose of 0.25 mg subcutaneously on successive days until r-hCG day.

Also known as: Cetrorelix acetate
Cetrotide®
Antagon ™DRUG

Antagon™ will be administered subcutaneously at a dose of 0.25 mg once daily when the lead follicle is \>=14 mm until r-hCG day.

Also known as: Ganirelix acetate
Antagon ™
Recombinant human follicle stimulating hormone (r-hFSH)DRUG

Recombinant human follicle stimulating hormone (r-hFSH) will be administered at a starting dose of 225 international unit (IU) subcutaneously once daily from S1 up to Stimulation Day 5 (S5). Beginning on Stimulation Day 6 (S6), the r-hFSH dose will be individualized to the subject. The minimum and maximum daily doses are 75 IU and 450 IU, respectively until r-hCG day.

Also known as: Gonal-f®
Antagon ™Cetrotide®
Human Menopausal Gonadotropin (hMG)DRUG

Human menopausal gonadotropin (hMG) will be administered subcutaneously daily at a dose of 75 IU till r-hCG day. The total daily dose of r-hFSH and hMG combined is not to exceed 450 IU (375 IU r-hFSH and 75 IU hMG).

Also known as: Pergonal®
Antagon ™Cetrotide®
Recombinant Human Choriogonadotropin (r-hCG)DRUG

The r-hCG will be administered as a single dose of 250 microgram (mcg) subcutaneously when there is at least one follicle of \>=18 mm and two additional follicles of \>=16 mm with an appropriate plasma estradiol levels for the number and size of the existing follicles. The r-hCG will be administered within 36 hours after the last dose of the r-hFSH/hMG.

Also known as: Ovidrel®, Choriogonadotropin alfa
Antagon ™Cetrotide®

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wilcox J, Potter D, Moore M, Ferrande L, Kelly E; CAP IV Investigator Group. Prospective, randomized trial comparing cetrorelix acetate and ganirelix acetate in a programmed, flexible protocol for premature luteinizing hormone surge prevention in assisted reproductive technologies. Fertil Steril. 2005 Jul;84(1):108-17. doi: 10.1016/j.fertnstert.2005.03.016.

    PMID: 16009165BACKGROUND

Related Links

MeSH Terms

Conditions

Infertility

Interventions

cetrorelixganirelixGlycoprotein Hormones, alpha Subunitfollitropin alfaMenotropinsOvidrelChorionic Gonadotropin

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

GonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsFollicle Stimulating HormoneGonadotropins, PituitaryLuteinizing HormonePituitary Hormones, AnteriorPituitary HormonesThyrotropinPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsBiological ProductsComplex MixturesPregnancy ProteinsProteins

Study Officials

  • Eduardo Kelly, MD, MBA

    EMD Serono

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2006

First Posted

March 1, 2006

Study Start

September 1, 2003

Primary Completion

May 1, 2004

Study Completion

May 1, 2004

Last Updated

March 26, 2014

Record last verified: 2014-03