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

June 27, 2013 updated by: Christophe Blockeel, Universitair Ziekenhuis Brussel

The Effect of the Type of Ovarian Stimulation Protocol on PGD Results: a Prospective Randomised Trial

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®).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1090
        • Centre for Reproductive Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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: Progesterone
Other Names:
  • Utrogestan vaginal tablets
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
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: Progesterone
Other Names:
  • Utrogestan vaginal tablets
Drug: hP-hMG
Other Names:
  • Menopur
Drug: Human chorionic gonadotropin
induction of final oocyte maturation
Other Names:
  • Pregnyl
Drug: GnRH antagonist
Other Names:
  • Orgalutran or Cetrotide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of day 3 embryos for biopsy available
Time Frame: up to 6 weeks
up to 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of mature cumulus-oocyte complexes
Time Frame: up to 6 weeks
up to 6 weeks
clinical pregnancy rate
Time Frame: up to 9 months
up to 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

June 21, 2013

First Submitted That Met QC Criteria

June 27, 2013

First Posted (Estimate)

June 28, 2013

Study Record Updates

Last Update Posted (Estimate)

June 28, 2013

Last Update Submitted That Met QC Criteria

June 27, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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