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

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ClinicalTrials.gov Identifier: NCT01577472
Recruitment Status : Completed
First Posted : April 13, 2012
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease Intervention/treatment Phase
Female Infertility Ovarian Insufficiency Drug: High Dose Clomiphencitrat Drug: Low Dose Clomiphencitrat Drug: High Dose Placebo Drug: Low dose Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Actual Study Start Date : August 2013
Primary Completion Date : November 14, 2017
Study Completion Date : November 14, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: High Dose Clomiphencitrat
450 IU Merional® plus 100mg Serophene®
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).
Active Comparator: Low Dose Clomiphencitrat
150 IU Merional® plus 100mg Serophene®
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).
Placebo Comparator: High Dose Placebo
450 IU Merional® plus Placebo
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).
Placebo Comparator: Low Dose Placebo
150 IU Merional® plus Placebo
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).



Primary Outcome Measures :
  1. number of collected oocytes [ Time Frame: 1 year ]

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


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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01577472


Locations
Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Rebecca E Moffat, MD University Hospital Basel, Women's Clinic

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01577472     History of Changes
Other Study ID Numbers: CANTAPOR_2012
First Posted: April 13, 2012    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018

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
Genital Diseases, Male
Genital Diseases, Female
Clomiphene
Enclomiphene
Zuclomiphene
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators