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All the studies, demonstrating improved oocyte maturity and high pregnancy rate with the dual trigger are all retrospective. The investigators therefore aim to perform a prospective randomized controlled study in normal responders, comparing cycles triggered with hCG to those triggered with hCG+GnRH agonist.
A prospective, randomized, double blinded clinical trial. Patients will undergo standard clinical and hormonal investigation as usual for IVF. Patients that will be given the standard GnRH antagonist IVF protocol will be prospectively randomized into two groups: 1. hCG group- will be triggered for final follicular maturation with hCG (Pregnyl 10,000IU) as is usual and placebo (normal saline) - 36 hours prior to oocyte aspiration. 2. The Double trigger group- will receive GnRH agonist (Suprefact 0.5 mg) and hCG (Pregnyl 10,000IU) 36 hours prior to the oocyte aspiration. All patients will be supplemented with the usual progesterone preparation (vaginal progesterone suppositories) for luteal support.
In order to increase the rate of MII from to 65% to 80% with an alpha error of 5% and beta error of 80% the sample size needed is 276 total patients in both groups or 138 patients in each group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double trigger | Experimental | Triggering of ovulation with GnRH agonist ( Suprefact 0.5mg) + hCG ( Pregnyl 10,000IU) |
|
| control | Placebo Comparator | Triggering of ovulation with hCH ( Pregnyl 10,000IU) + Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buseralin | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of mature oocytes | We will gather the information regarding the number of mature oocytes 2 days after the triggering- ( randomization) | 2 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Blastocyst rate | 8 days after the randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert F Casper, MD | Scientific Director TRIO IVF | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TRIO Fertility | Toronto | Ontario | M5G 2K4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38212582 | Derived | Ozelci R, Yenigul NN, Dilbaz S, Dilbaz B, Aldemir O, Kaplanoglu I, Gucel F, Baser E, Tekin OM. The Association of ICSI Outcomes with Semen and Blood Bisphenol A Concentrations of the Male Partner. Reprod Sci. 2024 May;31(5):1323-1331. doi: 10.1007/s43032-023-01446-y. Epub 2024 Jan 11. | |
| 32563188 | Derived | Haas J, Bassil R, Samara N, Zilberberg E, Mehta C, Orvieto R, Casper RF. GnRH agonist and hCG (dual trigger) versus hCG trigger for final follicular maturation: a double-blinded, randomized controlled study. Hum Reprod. 2020 Jul 1;35(7):1648-1654. doi: 10.1093/humrep/deaa107. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D002064 | Buserelin |
| D000077330 | Saline Solution |
| D006063 | Chorionic Gonadotropin |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Other |
|
|
| pregnyl | Drug |
|
|
| 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 |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D006062 | Gonadotropins |
| D010926 | Placental Hormones |
| D011257 | Pregnancy Proteins |