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

Universitair Ziekenhuis Brussel

Status and phase: Completed; Phase 4

Conditions: Fertility; Optimal Stimulation Protocol; Reproductive Endocrinology

Treatments: Drug: Progesterone; Drug: Human chorionic gonadotropin; Drug: hP-hMG; Drug: GnRH antagonist; Drug: GnRH agonist

Study type: Interventional

Funder types: Other

Identifiers

NCT01888744

2010/010

Details and patient eligibility

About

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®).

Full description

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

Enrollment: 120 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Group 1 (GnRH agonist group)

Active Comparator group

Description:

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)

Treatment:

Drug: GnRH agonist

Drug: hP-hMG

Drug: Human chorionic gonadotropin

Drug: Progesterone

Group 2 (GnRH antagonist group)

Active Comparator group

Description:

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.

Treatment:

Drug: hP-hMG

Drug: GnRH antagonist

Drug: Human chorionic gonadotropin

Drug: Progesterone