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| Name | Class |
|---|---|
| ART Fertility Clinics LLC | OTHER |
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The goal of this clinical trial is to compare GnRH-agonist trigger with dual GnRH-agonist and HCG trigger in oocyte donors.
The main questions it aims to answer are:
Final oocyte maturation is a critical step in the process of the Assisted Reproductive Technology (ART) treatment and has a certain impact on oocyte yield and oocyte competency. There are three different types of trigger: hCG, GnRH-agonist or dual trigger (hCG and GnRH-agonist combined), and the choice depends on the ovarian stimulation protocol, the ovarian response and on the clinical standard of the IVF clinic. As oocyte donors are at high risk for OHSS, a GnRH-agonist trigger (GnRH-a) is the most commonly used modality for triggering final maturation. However, a certain number of oocyte donors may have a suboptimal response to GnRH-a trigger only, with a yield of oocytes less than the 10th percentile, with a clear negative impact on oocyte efficiency and competency. This study aims to evaluate whether oocyte competence can be improved in oocyte donors with a previously suboptimal response to GnRH-a, by using a dual trigger in a subsequent ovarian stimulation cycle, in which hCG is added to the GnRH-agonist for final maturation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual trigger (GnRH-agonist plus hCG) | Experimental | Participants in this arm will be administered a GnRH-agonist trigger plus hCG (dual trigger) for final maturation |
|
| Gn-RH-agonist only trigger | Active Comparator | Participants in this arm will be administered a GnRH-agonist trigger only for final maturation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual trigger (human chorionic gonadotropin plus GnRH-agonist) | Drug | Human chorionic gonadotropin will be added to GnRH-agonist as a dual trigger in participants previously having had a suboptimal response to GnRH-agonist trigger only |
| Measure | Description | Time Frame |
|---|---|---|
| Oocyte maturation rate | Number of metaphase II oocytes per total number of oocytes retrieved in oocyte pick-up day | 18 months prospective trial |
| Fertilization rate | number of 2PN embryos per total number of MII oocytes fertilised | 18 months prospective trial |
| Blastulation rate | Number of blastocysts up to day 6 per number of fertilised 2PN embryos | 18 months prospective trial |
| Measure | Description | Time Frame |
|---|---|---|
| Number of recipients per donor cycle | The number of recipients matched per donor | 18 months prospective trial |
| Ongoing Pregnancy Rate | number of pregnancies with positive fetal heart per number of embryotransfers performed |
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Inclusion Criteria:
Exclusion Criteria:
Oocyte donors in IVF treatment
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Embryolab Fertility Clinic | Recruiting | Thessaloniki | 55133 | Greece |
At the trial completion IPD are to be shared with researchers from ART Fertility Clinics for statistical analysis
at the end of study as already submitted
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| GnRH-agonist only trigger | Drug | GnRH-agonist only will be used for final maturation |
|
| 28 months prospective trial |
| Live Birth Rate | number of live births per number of embryotransfers performed | 28 months prospective trial |
| ID | Term |
|---|---|
| D006063 | Chorionic Gonadotropin |
| D007987 | Gonadotropin-Releasing Hormone |
| ID | Term |
|---|---|
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010926 | Placental Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011257 | Pregnancy Proteins |
| D011506 | Proteins |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D009479 | Neuropeptides |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
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