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Comparing Ovarian Stimulation for Assisted Reproduction With Two Different Forms of Pituitary Suppression (Pergoveris)

This study is not yet open for participant recruitment.
Verified March 2012 by University of Basel
Sponsor:
Collaborator:
Merck Serono International SA
Information provided by (Responsible Party):
Christian De Geyter, University of Basel
ClinicalTrials.gov Identifier:
NCT01565265
First received: February 28, 2012
Last updated: March 25, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of this study is to assess the non-inferiority of a multidose GnRH antagonist (cetrorelix) regimen to a GnRH agonist (triptorelin) long protocol in young infertile women undergoing ovarian stimulation with Pergoveris 150 I.U./75 I.U. (r-hFSH/ r-hLH) for ICSI treatment because of male infertility.

To assess the efficacy of ovarian stimulation using either a GnRH antagonist (cetrorelix) or a GnRH agonist (triptorelin) long protocol in infertile women with good prognosis and to determine the safety of ovarian stimulation.

Subsample analysis: in 10 patients of each of both arms, serum samples will be collected daily during the stimulation period and be stored frozen at -70 °C. The following hormone concentrations will be measured later in single assay batches: LH, FSH, oestradiol, progesterone, androstenedione, testosterone, inhibin A, inhibin B, AMH.

Multinational, multicentre, open label, randomized, 2-arm parallel-group phase IV study. Eligible patients will be randomly allocated to one of the two groups: the agonist group will receive Decapeptyl® 0.1 mg (triptorelin) starting in the mid-luteal phase of the natural cycle until downregulation until the day of ovulation induction. The antagonist group will receive cetrorelix 0.25 mg from stimulation day 6 to ovulation induction. In both groups, Pergoveris® 150 I.U./75 I.U. (r-hFSH/r-hLH) will be used for ovarian stimulation from cycle day 2 to ovulation induction.


Condition Intervention
Female Infertility Due to Nonimplantation of Ovum
Complications Associated With Artificial Fertilization
 Drug: Pergoveris in long protocol with GnRH agonist
Drug: Pergoveris in GnRH antagonist protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Study Comparing Ovarian Stimulation With Pergoveris Supported by a GnRH Agonist in a Long Protocol Versus Multidose GnRH Antagonist Regimen in Young Infertile Women Treated With ICS

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Basel:

Primary Outcome Measures:
  • number of mature oocytes [ Time Frame: up to two years ] [ Designated as safety issue: No ]
    The primary objective of this study is to assess the non-inferiority of a multidose GnRH antagonist (cetrorelix) regimen to a GnRH agonist (triptorelin) long protocol in young infertile women undergoing ovarian hyperstimulation with Pergoveris for ICSI treatment because of male infertility. Non-inferiority is defined by the number of mature metaphase II oocytes available for ICSI.


Secondary Outcome Measures:
  • incidence of ovarian hyperstimulation syndrome (OHSS) [ Time Frame: up to two years ] [ Designated as safety issue: Yes ]
    The safety of ovarian stimulation with respect to the number of women suffering of the ovarian hyperstimulation syndrome (OHSS). OHSS is defined by enlargement of both ovaries together with ascites and haematocrit rise above 45%.

  • The number of early miscarriages. [ Time Frame: up to two years ] [ Designated as safety issue: Yes ]
    Miscarriage is defined a pregnancy loss within 12 weeks after the last menstruation.

  • The number of participants with adverse events. [ Time Frame: up to two years ] [ Designated as safety issue: Yes ]
    Adverse event is defined as any untoward medical occurrence in a patient or a clinical investigation subject, who was administerd a pharmaceutical product and which does not necessarily must have a causal relationship with the treatment.


Estimated Enrollment: 165
Study Start Date: April 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: GnRH agonist long protocol
Pergoveris will be administered daily from cycle day 2 to ovulation induction together with decapeptyl, which will be administered from the midluteal phase of the preceding menstrual cycle up to ovulation induction.
 Drug: Pergoveris in long protocol with GnRH agonist
Ovarian hyperstimulation with recombinant FSH and recombinant FSH Ovulation induction with recombinant HCG Oocyte collection for ICSI
Other Name: Pergoveris
Experimental: antagonist protocol
Pergoveris will be administered daily from cycle day 2 to ovulation induction together with Cetrotide, which will be administered from the day six up to ovulation induction.
 Drug: Pergoveris in GnRH antagonist protocol
Ovarian hyperstimulation with recombinant FSH and recombinant FSH Ovulation induction with recombinant HCG Oocyte collection for ICSI
Other Name: Cetrotide

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Female patients younger than 36 years of age with an indication for ICSI:

  • 20 to 35 years inclusive
  • body mass index between 19 and 30 kg/m2
  • indication for ICSI due to male infertility
  • cycle length 27 to 32 days
  • presence of both ovaries
  • rubella immunity
  • written informed consent

Exclusion Criteria:

  • age > 35 years
  • pregnancy and breast feeding
  • ovarian endometriosis
  • uterine fibroids interfering with endometrial proliferation
  • sperm retrieval from the epididymis or the testis
  • more than one previous ART treatment with pregnancy
  • known or suspected hypersensitivity to active substances
  • clinically relevant systemic disease
  • previous enrollment to this study
  • know or suspected non-compliance, drug or alcohol abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01565265

Contacts
Contact: Christian De Geyter, Prof. +41 61 265 9315 cdegeyter@uhbs.ch
Contact: Hanna Flükiger, Ms. +41 61 265 9315 hflueckiger@uhbs.ch

Locations
Switzerland
University Hospital of Basel Not yet recruiting
Basel, Switzerland, CH-4031
Contact: Christian De Geyter, Prof.     +41 61 265 9315     cdegeyter@uhbs.ch    
Contact: Hanna Flükiger, Ms.     +41 61 265 9315     hflueckiger@uhbs.ch    
Principal Investigator: Christian De Geyter, Prof.            
Sponsors and Collaborators
University of Basel
Merck Serono International SA
Investigators
Principal Investigator: Christian De Geter, Prof. University of Basel
  More Information

Publications:

Responsible Party: Christian De Geyter, Division Chief and Research Group Leader, University of Basel
ClinicalTrials.gov Identifier: NCT01565265     History of Changes
Other Study ID Numbers: UBCH001, UBCH001
Study First Received: February 28, 2012
Last Updated: March 25, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Basel:
ovarian hyperstimulation
GnRH antagonist
GnRH agonist
 assisted reproduction
FSH
LH

Additional relevant MeSH terms:
Infertility, Female
Infertility
Genital Diseases, Male
Genital Diseases, Female
Cetrorelix
Deslorelin
Triptorelin
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
 Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 23, 2013