Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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®).
Patients will be randomized at the outpatient clinic in two groups.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (GnRH agonist group) | Active Comparator | 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) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GnRH agonist | Drug |
|
| |
| GnRH antagonist |
| Measure | Description | Time Frame |
|---|---|---|
| Number of day 3 embryos for biopsy available | up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of mature cumulus-oocyte complexes | up to 6 weeks | |
| clinical pregnancy rate | up to 9 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Reproductive Medicine | Brussels | 1090 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
|
| hP-hMG | Drug |
|
|
| Human chorionic gonadotropin | Drug | induction of final oocyte maturation |
|
|
| Progesterone | Drug |
|
|
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| C092464 | LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)- |
| C061018 | ganirelix |
| C062876 | cetrorelix |
| D008596 | Menotropins |
| D006063 | Chorionic Gonadotropin |
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D006065 | Gonadotropins, Pituitary |
| D006062 | Gonadotropins |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D010926 | Placental Hormones |
| D011257 | Pregnancy Proteins |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
Not provided
Not provided