Clinical trial NCT05321511: Comparison of Triggers in Double Ovarian Stimulation (DuoStim).
Official title: Double Ovarian Stimulation (DuoStim) Comparison of Triggers: Is There Any Advantage Using 3 Different Methods of Trigger for the Second Egg Collection in Predicted Low Responders?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: IVF
LOW OVARIAN RESPONSE
Lead sponsor: Instituto Bernabeu
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 165
Sex: FEMALE
Minimum age (years): 28
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* BMI below 32
* 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:

* Non-compliance with instructions and/or non-formalization of consents or legal requirements for IVF.
* Concurrent participation in another study

Primary outcomes:
measure: number of retrieved oocytes
timeFrame: through study completion, usually will be evaluated on the last day of the treatment
measure: number of mature (MII) oocytes
timeFrame: through study completion, usually will be evaluated on the last day of the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Palma De Mallorca
country: Spain
facility: Instituto Bernabeu
state: Mallorca
city: Albacete
country: Spain
facility: Instituto Bernabeu
city: Alicante
country: Spain
facility: Instituto Bernabeu
city: Madrid
country: Spain
facility: Instituto Bernabeu
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.