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

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ClinicalTrials.gov Identifier: NCT01888744
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : June 28, 2013
Sponsor:
Information provided by (Responsible Party):
Christophe Blockeel, Universitair Ziekenhuis Brussel

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
Reproductive Endocrinology Fertility Optimal Stimulation Protocol Drug: GnRH agonist Drug: GnRH antagonist Drug: hP-hMG Drug: Human chorionic gonadotropin Drug: Progesterone Phase 4

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

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Study Type : Interventional  (Clinical Trial)
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 : September 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

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 Name: Suprefact nasal spray

Drug: hP-hMG
Other Name: Menopur

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

Drug: Progesterone
Other Name: 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 Name: Orgalutran or Cetrotide

Drug: hP-hMG
Other Name: Menopur

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

Drug: Progesterone
Other Name: Utrogestan vaginal tablets




Primary Outcome Measures :
  1. Number of day 3 embryos for biopsy available [ Time Frame: up to 6 weeks ]

Secondary Outcome Measures :
  1. Number of mature cumulus-oocyte complexes [ Time Frame: up to 6 weeks ]
  2. clinical pregnancy rate [ Time Frame: up to 9 months ]


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

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

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): NCT01888744


Locations
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Belgium
Centre for Reproductive Medicine
Brussels, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
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Responsible Party: Christophe Blockeel, Professor Doctor, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT01888744    
Other Study ID Numbers: 2010/010
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: June 28, 2013
Last Verified: June 2013
Keywords provided by Christophe Blockeel, Universitair Ziekenhuis Brussel:
Intracytoplasmic sperm injection (ICSI)
PGD
GnrH agonist
GnRH antagonist
Additional relevant MeSH terms:
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Chorionic Gonadotropin
Cetrorelix
Progesterone
Prolactin Release-Inhibiting Factors
Ganirelix
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Fertility Agents, Female
Fertility Agents
Hormone Antagonists