We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01577472
Recruitment Status : Completed
First Posted : April 13, 2012
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE April 5, 2012
First Posted Date  ICMJE April 13, 2012
Last Update Posted Date December 4, 2018
Actual Study Start Date  ICMJE August 2013
Actual Primary Completion Date November 14, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2012)
number of collected oocytes [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2012)
Implantation rate [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study Comparing the Effect of Clomiphencitrate to an Antagonist Protocol
Official Title  ICMJE 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
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Female Infertility
  • Ovarian Insufficiency
Intervention  ICMJE
  • Drug: High Dose Clomiphencitrat
    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: Low Dose Clomiphencitrat
    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: High Dose Placebo
    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: Low dose Placebo
    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).
Study Arms  ICMJE
  • Active Comparator: High Dose Clomiphencitrat
    450 IU Merional® plus 100mg Serophene®
    Intervention: Drug: High Dose Clomiphencitrat
  • Active Comparator: Low Dose Clomiphencitrat
    150 IU Merional® plus 100mg Serophene®
    Intervention: Drug: Low Dose Clomiphencitrat
  • Placebo Comparator: High Dose Placebo
    450 IU Merional® plus Placebo
    Intervention: Drug: High Dose Placebo
  • Placebo Comparator: Low Dose Placebo
    150 IU Merional® plus Placebo
    Intervention: Drug: Low dose Placebo
Publications * Moffat R, Hansali C, Schoetzau A, Ahler A, Gobrecht U, Beutler S, Raggi A, Sartorius G, De Geyter C. Randomised controlled trial on the effect of clomiphene citrate and gonadotropin dose on ovarian response markers and IVF outcomes in poor responders. Hum Reprod. 2021 Mar 18;36(4):987-997. doi: 10.1093/humrep/deaa336.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2018)
117
Original Estimated Enrollment  ICMJE
 (submitted: April 12, 2012)
120
Actual Study Completion Date  ICMJE November 14, 2017
Actual Primary Completion Date November 14, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 43 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01577472
Other Study ID Numbers  ICMJE CANTAPOR_2012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University Hospital, Basel, Switzerland
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rebecca E Moffat, MD University Hospital Basel, Women's Clinic
PRS Account University Hospital, Basel, Switzerland
Verification Date December 2018

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