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This study aims to investigate the efficacy of 3 different trigggers used for final maturation in the second ovarian stimulation in double stimulation protocol (aGnRH and hCG-rec vs. aGnRH only vs. hCG-rec only). The main objective is to compare the number of all retrieved oocytes and mature oocytes in patients predicted to be low ovarian responders.
This is a controlled randomized clinical study where 165 patients will be recruited.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| a-GnRH | Active Comparator | Administration of triptorelin acetate 0.2 mg for final oocyte maturation. |
|
| hCG | Active Comparator | Administration of coriogonadotropine alfa 250 mcg for final oocyte maturation. |
|
| a-GnRH + hCG | Experimental | Administration of triptorelin acetate 0.2 mg and coriogonadotropine alfa 250 mcg for final oocyte maturation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triptorelin acetate (a-GnRH) | Drug | Adminsitration of triptoreline acetate 0.2 mg for final oocyte maturation in the second ovarian stimuation inthe Double stimulation protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of retrieved oocytes | number of oocytes retrieved in the second ovarian stimulation in the double stimulation protocol. | through study completion, usually will be evaluated on the last day of the treatment |
| number of mature (MII) oocytes | number of mature (MII) oocytes retrieved in the second ovarian stimulation in the double stimulation protocol. | through study completion, usually will be evaluated on the last day of the treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Pitas, PhD | Contact | +34663926079 | apitas@institutobernabeu.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Bernabeu | Recruiting | Palma de Mallorca | Mallorca | 07006 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32208810 | Result | Castillo JC, Haahr T, Martinez-Moya M, Humaidan P. Gonadotropin-releasing hormone agonist ovulation trigger-beyond OHSS prevention. Ups J Med Sci. 2020 May;125(2):138-143. doi: 10.1080/03009734.2020.1737599. Epub 2020 Mar 25. | |
| 27567429 | Result | Pereira N, Elias RT, Neri QV, Gerber RS, Lekovich JP, Palermo GD, Rosenwaks Z. Adjuvant gonadotrophin-releasing hormone agonist trigger with human chorionic gonadotrophin to enhance ooplasmic maturity. Reprod Biomed Online. 2016 Nov;33(5):568-574. doi: 10.1016/j.rbmo.2016.08.009. Epub 2016 Aug 20. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 23, 2023 | |
| Reset | Jan 4, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 23, 2023 | Jan 4, 2024 |
| 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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|
| Ovitrelle® (hCG) | Drug | Adminsitration of coriogonadotropine alfa 250 mcg for final oocyte maturation in the second ovarian stimuation inthe Double stimulation protocol. |
|
| Decapeptyl 0.1 mg® (a-GnRH) and Ovitrelle® (hCG) used together | Drug | Adminsitration of triptoreline acetate 0.2 mg and coriogonadotropine alfa 250 mcg for final oocyte maturation in the second ovarian stimuation inthe Double stimulation protocol. |
|
| Instituto Bernabeu | Recruiting | Albacete | 02005 | Spain |
|
| Instituto Bernabeu | Recruiting | Alicante | 03016 | Spain |
|
| Instituto Bernabeu | Recruiting | Madrid | 28001 | Spain |
|
| 25311972 | Result | Moffat R, Pirtea P, Gayet V, Wolf JP, Chapron C, de Ziegler D. Dual ovarian stimulation is a new viable option for enhancing the oocyte yield when the time for assisted reproductive technnology is limited. Reprod Biomed Online. 2014 Dec;29(6):659-61. doi: 10.1016/j.rbmo.2014.08.010. Epub 2014 Sep 4. |
| 30609935 | Result | Lin MH, Wu FS, Hwu YM, Lee RK, Li RS, Li SH. Dual trigger with gonadotropin releasing hormone agonist and human chorionic gonadotropin significantly improves live birth rate for women with diminished ovarian reserve. Reprod Biol Endocrinol. 2019 Jan 4;17(1):7. doi: 10.1186/s12958-018-0451-x. |
| 25296696 | Result | Haas J, Zilberberg E, Dar S, Kedem A, Machtinger R, Orvieto R. Co-administration of GnRH-agonist and hCG for final oocyte maturation (double trigger) in patients with low number of oocytes retrieved per number of preovulatory follicles--a preliminary report. J Ovarian Res. 2014 Aug 2;7:77. doi: 10.1186/1757-2215-7-77. |
| 28993105 | Result | Zhang J, Wang Y, Mao X, Chen Q, Hong Q, Cai R, Zhang S, Kuang Y. Dual trigger of final oocyte maturation in poor ovarian responders undergoing IVF/ICSI cycles. Reprod Biomed Online. 2017 Dec;35(6):701-707. doi: 10.1016/j.rbmo.2017.09.002. Epub 2017 Sep 21. |
| 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 |