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History of Changes for Study: NCT01577472
Efficacy Study Comparing the Effect of Clomiphencitrate to an Antagonist Protocol (CANTAPOR)
Latest version (submitted December 3, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 12, 2012 None (earliest Version on record)
2 September 16, 2013 Recruitment Status, Study Status and Contacts/Locations
3 September 16, 2014 Contacts/Locations, Arms and Interventions and Study Status
4 March 16, 2015 Study Status
5 September 21, 2015 Study Status
6 March 24, 2016 Study Status
7 September 26, 2016 Study Status
8 September 28, 2017 Study Status
9 January 25, 2018 Recruitment Status, Study Status, Contacts/Locations and Study Design
10 December 3, 2018 Study Status
Comparison Format:

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Study NCT01577472
Submitted Date:  April 12, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: CANTAPOR_2012
Brief Title: Efficacy Study Comparing the Effect of Clomiphencitrate to an Antagonist Protocol (CANTAPOR)
Official Title: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2012
Overall Status: Not yet recruiting
Study Start: July 2012
Primary Completion: April 2014 [Anticipated]
Study Completion: July 2014 [Anticipated]
First Submitted: April 5, 2012
First Submitted that
Met QC Criteria:
April 12, 2012
First Posted: April 13, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 12, 2012
Last Update Posted: April 13, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University Hospital, Basel, Switzerland
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: 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.
Detailed Description:
Open or close this module Conditions
Conditions: Female Infertility
Ovarian Insufficiency
Keywords: female infertility
poor ovarian response
controlled ovarian hyperstimulation
IVF
Antagonist protocol
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 4
Interventional Study Model: Parallel Assignment
Number of Arms: 4
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 120 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: High Dose Clomiphencitrat
450 IU Merional® plus 100mg Serophene®
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).
Active Comparator: Low Dose Clomiphencitrat
150 IU Merional® plus 100mg Serophene®
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).
Placebo Comparator: High Dose Placebo
450 IU Merional® plus Placebo
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).
Placebo Comparator: Low Dose Placebo
150 IU Merional® plus Placebo
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).
Open or close this module Outcome Measures
Primary Outcome Measures:
1. number of collected oocytes
[ Time Frame: 1 year ]

Secondary Outcome Measures:
1. Implantation rate
[ Time Frame: 1 year ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 43 Years
Sex: Female
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Rebecca E Moffat, MD
Telephone: +41 61 328 7980
Email: moffatr@uhbs.ch
Study Officials: Rebecca E Moffat, MD
Principal Investigator
University Hospital Basel, Women's Clinic
Locations: Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Contact:Contact: Rebecca E Moffat, MD +41 61 328 79 80 moffatr@uhbs.ch
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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