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This is a prospective, randomized, single center, phase 4 controlled trial. The study will compare the efficacy of two different strategies for the management of predicted poor response patients under stimulation for IVF/ICSI: up to three MNC cycles (group 1) versus a single GnRH antagonist CFA (group 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Up to 3 modified natural cycles | Active Comparator |
| |
| Controlled ovarian stimulation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A single Gonadotropin-Releasing Hormone (GnRH) antagonist corifollitropin alfa (CFA) stimulation | Drug | CFA will be administered in combination with Follitropin beta. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of good quality blastocysts after CFA stimulation vs. after a first MNC | On fifth day of embryonal development |
| Measure | Description | Time Frame |
|---|---|---|
| Number of good quality blastocysts after CFA stimulation vs. after a second or third MNC | On fifth day of embryonal development | |
| The relative number of blastocysts after ART, relative to the number of oocytes | On fifth day of embryonal development |
| Measure | Description | Time Frame |
|---|---|---|
| The probability of having an ongoing pregnancy | 6 to 8 weeks gestational age | |
| The time until ongoing pregnancy | 6 to 8 weeks gestational age |
Inclusion Criteria:
POSEIDON Group 3: patients < 35 years with poor ovarian reserve pre-stimulation parameters (AFC <5 or AMH <1.2 ng/mL); POSEIDON Group 4: patients ≥35 years with poor ovarian reserve pre-stimulation parameters (AFC <5 or AMH <1.2 ng/mL).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Somers, MSc | Contact | 0032 9 332 30 48 | studieco.vrouwenkliniek@uzgent.be |
| Name | Affiliation | Role |
|---|---|---|
| Dominic Stoop, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ghent | Recruiting | Ghent | 9000 | Belgium |
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| Up to three modified natural cycles with Follitropin beta. | Drug | Follitropin beta in a low dose will be given. |
|
| The probability of having at least one blastocyst of good quality after ART | On fifth day of embryonal development |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| C571802 | follitropin beta |
| 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 |
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