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This is a randomized controlled clinical trial to investigate the effect of dual trigger (hCG and GnRH agonist) on the final oocyte maturation compared to the standard hCG trigger in patients with poor ovarian reserve seeking IVF/ICSI treatment.
Women with POR (Bologna criteria) manifest a very low follicular response to controlled ovarian stimulation irrespective of the stimulation protocol utilized. Dual triggering of oocyte maturation was shown to improve follicle collection yield and oocyte maturation in women with predicted normal ovarian response. These benefits have been attributed to the GnRHa-induced FSH surge believed to promote oocyte nuclear maturation and cumulus expansion. The aim of the study is to show whether the co-administration of a GnRH agonist and hCG for final oocyte maturation improve oocyte collection and maturation rate
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual trigger | Experimental | Dual trigger: (0.3 mg GnRHa = triptorelin) with + HCG (Choriomon)10 000 IU . will be administered subcutaneously in a single dose 0.3 mg with 10 000 HCG when at least 2 follicles 18 mm in diameter have been observed by ultrasound examination. |
|
| hCG (standard) | Active Comparator | HCG (Choriomon) of 10 000 IU will be administered subcutaneously in a single dose when at least 2 follicles 18 mm in diameter have been observed by ultrasound examination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual trigger | Drug | Dual trigger: human Chorionic Gonadotropin (Choriomon 10,000 IU subcutaneous once) + Gonadotropin-Releasing Hormone agonist (Triptorelin 0.3 mg subcutaneous once) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of oocytes retrieved (oocyte collection rate) | the total number of oocytes retrieved divided by the number of follicles aspirated (diameter ≥10 mm) on the day of oocyte retrieval | 38 hrs |
| Number of mature oocytes (oocyte maturation rate) | the ratio of MII oocytes to the number of collected oocytes | 38 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| Fertilization rate | the ratio of normal fertilized oocytes (2PN) to the number of oocytes used for fertilization | 48 hrs |
| Clinical pregnancy rate | the presence of fetal cardiac activity confirmed by transvaginal ultrasound 7 weeks after embryo transfer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ghina S Ghazeeri, MD | American University of Beirut Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American University of Beirut Medical Center | Beirut | Lebanon |
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| ID | Term |
|---|---|
| D017329 | Triptorelin Pamoate |
| D006063 | Chorionic Gonadotropin |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| hCG (standard) | Drug | human Chorionic Gonadotropin (Choriomon 10,000 IU subcutaneous once) |
|
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| 7 weeks |
| Implantation rate | the number of gestational sacs visualized on ultrasound examination divided by the number of embryos transferred | 7 weeks |
| Miscarriage rate | the spontaneous loss of a clinical pregnancy occurring before 12 completed weeks of gestational age | 12 weeks |
| 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 |
| D006062 | Gonadotropins |
| D010926 | Placental Hormones |
| D011257 | Pregnancy Proteins |