Efficacy Study Comparing the Effect of Clomiphencitrate to an Antagonist Protocol (CANTAPOR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University Hospital, Basel, Switzerland
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01577472
First received: April 5, 2012
Last updated: September 16, 2013
Last verified: September 2013

April 5, 2012
September 16, 2013
August 2013
April 2015   (final data collection date for primary outcome measure)
number of collected oocytes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01577472 on ClinicalTrials.gov Archive Site
Implantation rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy Study Comparing the Effect of Clomiphencitrate to an Antagonist Protocol
Prospective Randomized Phase IV Study Comparing the Effect of Adding Clomiphencitrate Versus Placebo to a High Dose Versus a Minimal Dose GnRH Antagonist Protocol on the Number of Oocytes Collected From Women That Are Poor Responders

The aim of this study is to assess the oocyte yield of infertile women with suspected or known poor ovarian reserve (POR) undergoing a GnRH antagonist protocol for IVF with Merional® starting either with a low (150 IU) or a high dose (450 IU) and adding 100mg of CC (Serophene®) in the early follicular phase of the stimulation (day 3 to 7). To date no RCT has been conducted to compare the reproductive outcome of patients with POR as defined by the ESHRE Bologna criteria after controlled ovarian hyperstimulation with HMG in an GnRH antagonist protocol using low doses versus high doses of HMG and adding CC versus placebo. We hypothesize that adding 100 mg of CC on day 3-7 to a HMG antagonist protocol will lead to an additional increment of endogenous GT thus increasing the oocytes yield after controlled ovarian stimulation due to higher endogenous gonadotropin secretion.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Female Infertility
  • Ovarian Insufficiency
  • Drug: Serophene High Dose
    100mg of clomiphencitrate(Serophene®) are added to a high dose of HMG (450 IU of Merional®) in the early follicular phase of the stimulation (day 3 to 7).
  • Drug: Serophene Low Dose
    100mg of clomiphencitrate(Serophene®) are added to a low dose of HMG (150 IU of Merional®) in the early follicular phase of the stimulation (day 3 to 7).
  • Drug: Placebo High Dose
    Placebo is added to a high dose of HMG (450 IU of Merional®) in the early follicular phase of the stimulation (day 3 to 7).
  • Drug: Placebo Low dose
    Placebo is added to a low dose of HMG (150 IU of Merional®) in the early follicular phase of the stimulation (day 3 to 7).
  • Active Comparator: High Dose Clomiphencitrat
    450 IU Merional® plus 100mg Serophene®
    Intervention: Drug: Serophene High Dose
  • Active Comparator: Low Dose Clomiphencitrat
    150 IU Merional® plus 100mg Serophene®
    Intervention: Drug: Serophene Low Dose
  • Placebo Comparator: High Dose Placebo
    450 IU Merional® plus Placebo
    Intervention: Drug: Placebo High Dose
  • Placebo Comparator: Low Dose Placebo
    150 IU Merional® plus Placebo
    Intervention: Drug: Placebo Low dose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
July 2015
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age: >18 years < 43 years
  • BMI: ≥ 18 ≤ 32 kg/m2
  • Poor responder as defined by ESHRE working group

Exclusion Criteria:

  • Age < 18 und > 43 years
  • Pregnancy
  • Breast feeding
  • Uterine conditions interfering with endometrial proliferation and embryo implantation (submucous fibroids or polyps)
  • Women diagnosed with PCOS according to the Rotterdam criteria
  • Hyperprolactinaemia - untreated
  • Both ovaries not accessible transvaginally for oocyte pick up
  • Ovarian cysts of unclear dignity
  • Evidence of hydrosalpinx on ultrasound
  • Clinically significant severe systemic disease that are incompatible with pregnancy
  • Known or suspected hypersensitivity to the active substances (gonadotrophins, ganirelix, progesterone, clomiphencitrate)
  • Untreated thyroid or adrenal disorders
  • Bleeding disorders
  • Cancer
  • Severe renal or hepatic dysfunction
  • Necessity to take medication that could influence ovarian stimulation
  • History of OHSS in prior IVF cycle
Female
18 Years to 43 Years
Yes
Contact: Rebecca E Moffat, MD +41 61 328 7980 moffatr@uhbs.ch
Switzerland
 
NCT01577472
CANTAPOR_2012
Yes
University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
Not Provided
Principal Investigator: Rebecca E Moffat, MD University Hospital Basel, Women's Clinic
University Hospital, Basel, Switzerland
September 2013

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