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

This study is not yet open for participant recruitment.
Verified April 2012 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: April 12, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Female Infertility
Ovarian Insufficiency
 Drug: Serophene High Dose
Drug: Serophene Low Dose
Drug: Placebo High Dose
Drug: Placebo Low dose
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • number of collected oocytes [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Implantation rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   18 Years to 43 Years
Genders Eligible for Study:   Female
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577472

Contacts
Contact: Rebecca E Moffat, MD +41 61 328 7980 moffatr@uhbs.ch

Locations
Switzerland
University Hospital Basel Not yet recruiting
Basel, Switzerland, 4031
Contact: Rebecca E Moffat, MD     +41 61 328 79 80     moffatr@uhbs.ch    
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Rebecca E Moffat, MD University Hospital Basel, Women's Clinic
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01577472     History of Changes
Other Study ID Numbers: CANTAPOR_2012
Study First Received: April 5, 2012
Last Updated: April 12, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
female infertility
poor ovarian response
controlled ovarian hyperstimulation
IVF
Antagonist protocol

Additional relevant MeSH terms:
Infertility
Infertility, Female
Menopause, Premature
Primary Ovarian Insufficiency
Genital Diseases, Male
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Clomiphene
 Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators

ClinicalTrials.gov processed this record on May 22, 2013