Comparison of Triggers in Double Ovarian Stimulation (DuoStim).

IVF Clinical Trial

— COTRID  

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?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05321511
• Other study ID #: IB-0121
• Status: Recruiting
• Phase: Phase 4
• Start date: March 3, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2022
• Source: Instituto Bernabeu
• Contact: Anna Pitas, PhD
• Phone: +34663926079
• Email: apitas[@]institutobernabeu.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 165
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 28 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• IVF

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Spain	Instituto Bernabeu	Albacete
Spain	Instituto Bernabeu	Alicante
Spain	Instituto Bernabeu	Madrid
Spain	Instituto Bernabeu	Palma De Mallorca	Mallorca

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Bernabeu

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Castillo JC, Haahr T, Martínez-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. Review. — View 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 repo — View 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( — View 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: — View 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 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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