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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01565265
First Posted: March 28, 2012
Last Update Posted: May 1, 2017
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.
Collaborator:
Merck Serono International SA
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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

Primary Outcome Measures:
  • number of mature oocytes [ Time Frame: up to two years ]
    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 ]
    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 ]
    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 ]
    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.


Enrollment: 5
Study Start Date: April 2012
Study Completion Date: December 2013
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes 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
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): NCT01565265


Locations
Switzerland
University Hospital of Basel
Basel, Switzerland, CH-4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Merck Serono International SA
Investigators
Principal Investigator: Christian De Geter, Prof. University of Basel
  More Information

Publications:

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01565265     History of Changes
Other Study ID Numbers: UBCH001
UBCH001 ( Other Grant/Funding Number: University Hospital of Basel, Switzerland )
First Submitted: February 28, 2012
First Posted: March 28, 2012
Last Update Posted: May 1, 2017
Last Verified: April 2017

Keywords provided by University Hospital, Basel, Switzerland:
ovarian hyperstimulation
GnRH antagonist
GnRH agonist
assisted reproduction
FSH
LH

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Prolactin Release-Inhibiting Factors
Follicle Stimulating Hormone
Cetrorelix
Deslorelin
Triptorelin Pamoate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Fertility Agents, Female
Fertility Agents
Hormone Antagonists