Skip to main content
OpenTrials
Completed

NCT Number: NCT00298025

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Cetrorelix acetate

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.

Other names: Ganirelix acetate

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.

Other names: Gonal-f®

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).

Other names: Pergonal®

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.

Other names: Ovidrel®, Choriogonadotropin alfa

Primary outcomes

  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

  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})

Sponsors and collaborators

Lead sponsor

EMD Serono

Industry

Registry information

Official study title

A Phase IV, Multicenter, Open-label, Randomized Study to Compare the Safety and Efficacy of Cetrotide® 3 mg Versus Antagon™ in the Inhibition of a Premature LH Surge in a r-hFSH/hMG Stimulation Cycle With OCP Programming in Women Undergoing Ovarian Stimulation Prior to ART

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Mar 1, 2006
Registry last updated
Mar 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.