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Infertile Women Undergoing Assisted Reproductive Technology (ART)Phase 4NCT00298025

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

A Phase 4 study testing Cetrotide®, Antagon ™ and Recombinant human follicle stimulating hormone (r-hFSH) in people with Infertile Women Undergoing Assisted Reproductive Technology (ART), run by EMD Serono.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 39 years, women only
What is being tested?
Cetrotide®, Antagon ™ and Recombinant human follicle stimulating hormone (r-hFSH)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
185 participants
Where
No sites listed yet
Study dates
Sep 2003to May 2004
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 39 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

About this study

Official 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

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.

Being tested
Cetrotide®, Antagon ™, Recombinant human follicle stimulating hormone (r-hFSH), Human Menopausal Gonadotropin (hMG), Recombinant Human Choriogonadotropin (r-hCG)
Keywords
Infertility, Cetrotide, Antagon, Recombinant human follicle stimulating hormone (r-hFSH), Human Menopausal Gonadotropin (hMG), Recombinant Human Choriogonadotropin (r-hCG)
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cetrotide®Drug

    Also called Cetrorelix acetate

    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.

  • Antagon ™Drug

    Also called Ganirelix acetate

    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.

  • Recombinant human follicle stimulating hormone (r-hFSH)Drug

    Also called Gonal-f®

    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.

  • Human Menopausal Gonadotropin (hMG)Drug

    Also called Pergonal®

    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).

  • Recombinant Human Choriogonadotropin (r-hCG)Drug

    Also called Ovidrel®, Choriogonadotropin alfa

    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.

Study groups in NCT00298025
Study groupRoleWhat they receive
Cetrotide®ExperimentalNot described
Receives: Drug: Cetrotide®; Drug: Recombinant human follicle stimulating hormone (r-hFSH); Drug: Human Menopausal Gonadotropin (hMG); Drug: Recombinant Human Choriogonadotropin (r-hCG)
Antagon ™Active comparatorNot described
Receives: Drug: Antagon ™; Drug: Recombinant human follicle stimulating hormone (r-hFSH); Drug: Human Menopausal Gonadotropin (hMG); Drug: Recombinant Human Choriogonadotropin (r-hCG)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (12)

  1. Duration of study treatment

    Measured: 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

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

  3. Duration of gonadotropin therapy

    Measured: 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

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

  5. Number of oocytes retrieved

    Measured: 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

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

  7. Number of fertilized oocytes

    Measured: 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

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

  9. Implantation rate

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

  10. Total number of transferred and cryopreserved embryos

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2006 (estimated)
  2. Study startSep 2003
  3. Primary completionMay 2004
  4. Study completionMay 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
185 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00298025
Sponsor's protocol ID
24688
Status last verified
Mar 2014
First submitted
27 Feb 2006
Last updated
26 Mar 2014
Results posted
No

Publications

  • 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.

    PubMed 16009165

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cetrotide®, Antagon ™ and Recombinant human follicle stimulating hormone (r-hFSH) in people with Infertile Women Undergoing Assisted Reproductive Technology (ART), run by EMD Serono.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of subjects without premature luteinizing hormone (LH) surge (time frame: r-hCG administration day (end of stimulation cycle {approximately 4 days})). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00298025, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2014.

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