Clincosm LogoSign in Get a demo

Avanti: Preimplantation Genetic Diagnosis (PGD) With Gonadotropin-releasing Hormone (GnRH) Agonist Versus Antagonist

Sponsor
Universitair Ziekenhuis Brussel (Other)
Overall Status
Completed
CT.gov ID
NCT01888744
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
33
Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of our study is to define the optimal ovarian stimulation protocol concerning PGD and for this reason we plan a randomized controlled trial (RCT) comparing gonadotropin-releasing hormone (GnRH) agonist protocol versus GnRH antagonist protocol. The follicle stimulating hormone (FSH) preparation in both arms will be highly purified FSH (Menopur®).

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Patients will be randomized at the outpatient clinic in two groups.

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
The Effect of the Type of Ovarian Stimulation Protocol on PGD Results: a Prospective Randomised Trial
Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group 1 (GnRH agonist group)

The long GnRH agonist protocol starts on day 21 of the preceding cycle with the administration of GnRH agonist, Decapeptyl® 0,1 mg subcutaneously daily or buserelin acetate, Suprefact® 600 μg daily intranasal. The administration of highly purified human menopausal gonadotropin (hp-HMG), Menopur® 225 IU subcutaneously is started after three weeks of desensitization. The desensitization is checked by ultrasound (absence of cysts) and hormonal measurement (Estradiol levels < 80 pg/ml, FSH ≤ 10 IU/l and progesterone < 1,5ng/ml)

Drug: GnRH agonist
Other Names:
  • Suprefact nasal spray

    • Drug: hP-hMG
    Other Names:
  • Menopur

    • Drug: Human chorionic gonadotropin
    induction of final oocyte maturation
    Other Names:
  • Pregnyl

    • Drug: Progesterone
    Other Names:
  • Utrogestan vaginal tablets

    		•
    Active Comparator: Group 2 (GnRH antagonist group)

    Ovarian stimulation is started at day 2 of the menstrual cycle with 225 IU of HMG (Menopur ®) subcutaneously. At day 6 of the stimulation GnRH antagonist (Orgalutran®) 0,25 mg subcutaneously is added. Basal hormonal status will be confirmed in the antagonist group before starting.

    Drug: GnRH antagonist
    Other Names:
  • Orgalutran or Cetrotide

    • Drug: hP-hMG
    Other Names:
  • Menopur

    • Drug: Human chorionic gonadotropin
    induction of final oocyte maturation
    Other Names:
  • Pregnyl

    • Drug: Progesterone
    Other Names:
  • Utrogestan vaginal tablets

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of day 3 embryos for biopsy available [up to 6 weeks]

    Secondary Outcome Measures

    1. Number of mature cumulus-oocyte complexes [up to 6 weeks]

    2. clinical pregnancy rate [up to 9 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 39 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • ≤ 39 years the day of oocyte retrieval

    • BMI ≤ 29

    • cycle rank 1

    • menstrual cycle 25-36 days

    • PGD or preimplantation genetic screening (PGS) requested

    • ICSI

    • Single embryo transfer (SET) on day 5

    Exclusion Criteria:

    • Polycystic Ovary Syndrome (PCOS) (according Rotterdam criteria)

    • Hormonal disturbances

    • Endometriosis grade III and IV

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre for Reproductive Medicine Brussels Belgium 1090

    Sponsors and Collaborators

    • Universitair Ziekenhuis Brussel

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Christophe Blockeel, Professor Doctor, Universitair Ziekenhuis Brussel
    ClinicalTrials.gov Identifier:
    NCT01888744
    Other Study ID Numbers:
    • 2010/010
    First Posted:
    Jun 28, 2013
    Last Update Posted:
    Jun 28, 2013
    Last Verified:
    Jun 1, 2013
    Keywords provided by Christophe Blockeel, Professor Doctor, Universitair Ziekenhuis Brussel
    Intracytoplasmic sperm injection (ICSI)
    PGD
    GnrH agonist
    GnRH antagonist
    Additional relevant MeSH terms:
    Chorionic Gonadotropin
    Cetrorelix
    Progesterone
    Prolactin Release-Inhibiting Factors
    Ganirelix

    Study Results

    No Results Posted as of Jun 28, 2013