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Trial · Interventional

Status unknownPhase 4Registry data

Comparison of Triggers in Double Ovarian Stimulation (DuoStim).

Short name COTRID

NCTNCT05321511 (opens ClinicalTrials.gov in a new tab)Other idIB-0121
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
165 participants (estimated)
Sponsor
Instituto Bernabeu · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Spain

Start
3 Mar 2022
Primary completion
31 Dec 2022 (estimated)
Completion
31 Mar 2023 (estimated)
First posted
11 Apr 2022
Last update posted
11 Apr 2022
Conditions
IVF · LOW OVARIAN RESPONSE

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202220232024
  1. Ph 4

    COTRID

    NCT05321511

    3 Mar 2022 to est. 31 Mar 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Triptorelin acetate (a-GnRH)Drug
  • Ovitrelle® (hCG)Drug
  • Decapeptyl 0.1 mg® (a-GnRH) and Ovitrelle® (hCG) used togetherDrug

Arms3

  • Active comparator

    a-GnRH

    Administration of triptorelin acetate 0.2 mg for final oocyte maturation.

  • Active comparator

    hCG

    Administration of coriogonadotropine alfa 250 mcg for final oocyte maturation.

  • Experimental

    a-GnRH + hCG

    Administration of triptorelin acetate 0.2 mg and coriogonadotropine alfa 250 mcg for final oocyte maturation.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. number of retrieved oocytes

    Time frame · through study completion, usually will be evaluated on the last day of the treatment

    Registry description

    number of oocytes retrieved in the second ovarian stimulation in the double stimulation protocol.

  2. number of mature (MII) oocytes

    Time frame · through study completion, usually will be evaluated on the last day of the treatment

    Registry description

    number of mature (MII) oocytes retrieved in the second ovarian stimulation in the double stimulation protocol.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultCastillo 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. PMID 32208810
  • ResultPereira 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. PMID 27567429
  • ResultMoffat 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. PMID 25311972
  • ResultLin 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. PMID 30609935
  • ResultHaas 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. PMID 25296696
  • ResultZhang 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. PMID 28993105

Eligibility

Who could join, as posted.

Sex
Female
Age
from 28 Years up to 43 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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