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Trial · Interventional

CompletedPhase 4Registry data

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

Short name Avanti

NCTNCT01888744 (opens ClinicalTrials.gov in a new tab)Other id2010/010
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Overview

Status
Completed
Phase
Phase 4
Enrollment
120 participants (actual)
Sponsor
Universitair Ziekenhuis Brussel · Other
Design
Randomized · Single masking
Countries
1 country

Belgium

Start
Sept 2010
Primary completion
Jun 2013
Completion
Jun 2013
First posted
28 Jun 2013 (estimated)
Last update posted
28 Jun 2013 (estimated)
Conditions
Reproductive Endocrinology · Fertility · Optimal Stimulation Protocol

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20102011201220132014
  1. Ph 4

    Avanti

    NCT01888744

    Sept 2010 to Jun 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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®).

Interventions

  • GnRH agonistDrug
  • GnRH antagonistDrug
  • hP-hMGDrug
  • Human chorionic gonadotropinDrug
  • ProgesteroneDrug

Arms2

  • 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)

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of day 3 embryos for biopsy available

    Time frame · up to 6 weeks

Secondary outcomes(2)

  1. Number of mature cumulus-oocyte complexes

    Time frame · up to 6 weeks

  2. clinical pregnancy rate

    Time frame · up to 9 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 39 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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