NCT05321511

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
165

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

10 months

First QC Date

March 24, 2022

Last Update Submit

April 4, 2022

Conditions

IVFLOW OVARIAN RESPONSE

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

a-GnRH

ACTIVE COMPARATOR

Administration of triptorelin acetate 0.2 mg for final oocyte maturation.

Drug: Triptorelin acetate (a-GnRH)

hCG

ACTIVE COMPARATOR

Administration of coriogonadotropine alfa 250 mcg for final oocyte maturation.

Drug: Ovitrelle® (hCG)

a-GnRH + hCG

EXPERIMENTAL

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

Drug: Decapeptyl 0.1 mg® (a-GnRH) and Ovitrelle® (hCG) used together

Interventions

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.

Also known as: Decapeptyl 0.1 mg®
a-GnRH
Ovitrelle® (hCG)DRUG

Adminsitration of coriogonadotropine alfa 250 mcg for final oocyte maturation in the second ovarian stimuation inthe Double stimulation protocol.

hCG
Decapeptyl 0.1 mg® (a-GnRH) and Ovitrelle® (hCG) used togetherDRUG

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.

a-GnRH + hCG

Eligibility Criteria

Age28 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Instituto Bernabeu

Palma de Mallorca, Mallorca, 07006, Spain

RECRUITING

Instituto Bernabeu

Albacete, 02005, Spain

RECRUITING

Instituto Bernabeu

Alicante, 03016, Spain

RECRUITING

Instituto Bernabeu

Madrid, 28001, Spain

RECRUITING

Related Publications (6)

  • 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.

    PMID: 32208810RESULT

  • 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.

    PMID: 27567429RESULT

  • 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.

    PMID: 25311972RESULT

  • 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.

    PMID: 30609935RESULT

  • 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.

    PMID: 25296696RESULT

  • 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.

    PMID: 28993105RESULT

MeSH Terms

Interventions

Triptorelin PamoateChorionic Gonadotropin

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsGonadotropinsPlacental HormonesPregnancy Proteins

Central Study Contacts

Anna Pitas, PhD

CONTACT

+34663926079apitas@institutobernabeu.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Director

Study Record Dates

First Submitted

March 24, 2022

First Posted

April 11, 2022

Study Start

March 3, 2022

Primary Completion

December 31, 2022

Study Completion

March 31, 2023

Last Updated

April 11, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(4)