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

NCT ID: NCT01888744

Last Updated: 2013-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-06-30

Brief Summary

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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®).

Detailed Description

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

Conditions

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Reproductive Endocrinology Fertility Optimal Stimulation Protocol

Keywords

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Intracytoplasmic sperm injection (ICSI) PGD GnrH agonist GnRH antagonist

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

GnRH agonist

Intervention Type DRUG

hP-hMG

Intervention Type DRUG

Human chorionic gonadotropin

Intervention Type DRUG

induction of final oocyte maturation

Progesterone

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

GnRH antagonist

Intervention Type DRUG

hP-hMG

Intervention Type DRUG

Human chorionic gonadotropin

Intervention Type DRUG

induction of final oocyte maturation

Progesterone

Intervention Type DRUG

Interventions

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GnRH agonist

Intervention Type DRUG

GnRH antagonist

Intervention Type DRUG

hP-hMG

Intervention Type DRUG

Human chorionic gonadotropin

induction of final oocyte maturation

Intervention Type DRUG

Progesterone

Intervention Type DRUG

Other Intervention Names

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Suprefact nasal spray Orgalutran or Cetrotide Menopur Pregnyl Utrogestan vaginal tablets

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Christophe Blockeel

Professor Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centre for Reproductive Medicine

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2010/010

Identifier Type: -

Identifier Source: org_study_id