Comparison of Triggers in Double Ovarian Stimulation (DuoStim).
NCT ID: NCT05321511
Last Updated: 2022-04-11
Study Results
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Basic Information
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UNKNOWN
PHASE4
165 participants
INTERVENTIONAL
2022-03-03
2023-03-31
Brief Summary
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This is a controlled randomized clinical study where 165 patients will be recruited.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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a-GnRH
Administration of triptorelin acetate 0.2 mg for final oocyte maturation.
Triptorelin acetate (a-GnRH)
Adminsitration of triptoreline acetate 0.2 mg for final oocyte maturation in the second ovarian stimuation inthe Double stimulation protocol.
hCG
Administration of coriogonadotropine alfa 250 mcg for final oocyte maturation.
Ovitrelle® (hCG)
Adminsitration of coriogonadotropine alfa 250 mcg for final oocyte maturation in the second ovarian stimuation inthe Double stimulation protocol.
a-GnRH + hCG
Administration of triptorelin acetate 0.2 mg and coriogonadotropine alfa 250 mcg for final oocyte maturation.
Decapeptyl 0.1 mg® (a-GnRH) and Ovitrelle® (hCG) used together
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.
Interventions
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Triptorelin acetate (a-GnRH)
Adminsitration of triptoreline acetate 0.2 mg for final oocyte maturation in the second ovarian stimuation inthe Double stimulation protocol.
Ovitrelle® (hCG)
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presence of both ovaries
* Indication for ovarian stimulation under Double Stimulation protocol (Duo Stim)
* Meeting the criteria for Duo Stim
* Medical history, history and physical examination without alterations
* AMH and AFV results in accordnace to Poseidon classification group 3 or 4 no more than 6 months prior to signing the consent form
* Ability to participate and comply with the study protocol.
* To have given written consent
* Normal karyotype and fragile X.
Exclusion Criteria
* Concurrent participation in another study
28 Years
43 Years
FEMALE
Yes
Sponsors
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Instituto Bernabeu
OTHER
Responsible Party
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Andrea Bernabeu García
Co-Director
Locations
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Instituto Bernabeu
Palma de Mallorca, Mallorca, Spain
Instituto Bernabeu
Albacete, , Spain
Instituto Bernabeu
Alicante, , Spain
Instituto Bernabeu
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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IB-0121
Identifier Type: -
Identifier Source: org_study_id
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