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

Phase 4

Completed

• Conditions: Reproductive Endocrinology; Fertility; Optimal Stimulation Protocol
• Interventions: Drug: GnRH agonist; Drug: GnRH antagonist; Drug: hP-hMG; Drug: Human chorionic gonadotropin; Drug: Progesterone

• Registration Number: NCT01888744
• Lead Sponsor: 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®).

Detailed Description

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

Study Timeline

• Study Start: 2010-09
• Status Verified: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Study First Submitted: 2013-06-21
• Study First Submitted QC: 2013-06-27
• Last Update Submitted: 2013-06-27
• Study First Posted: 2013-06-28
• Last Update Posted: 2013-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (GnRH agonist group)	GnRH agonist	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 1 (GnRH agonist group)	hP-hMG	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 2 (GnRH antagonist group)	GnRH antagonist	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 2 (GnRH antagonist group)	hP-hMG	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 1 (GnRH agonist group)	Progesterone	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 1 (GnRH agonist group)	Human chorionic gonadotropin	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 2 (GnRH antagonist group)	Human chorionic gonadotropin	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 2 (GnRH antagonist group)	Progesterone	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 Outcome Measures

Name	Time	Method
Number of day 3 embryos for biopsy available	up to 6 weeks

Secondary Outcome Measures

Name	Time	Method
Number of mature cumulus-oocyte complexes	up to 6 weeks
clinical pregnancy rate	up to 9 months

Trial Locations

Locations (1)

Centre for Reproductive Medicine; 🇧🇪 Brussels, Belgium