Comparison of Triggers in Double Ovarian Stimulation (DuoStim).

NCT ID: NCT05321511

Last Updated: 2022-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-03

Study Completion Date

2023-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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IVF LOW OVARIAN RESPONSE

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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a-GnRH

Administration of triptorelin acetate 0.2 mg for final oocyte maturation.

Group Type ACTIVE_COMPARATOR

Triptorelin acetate (a-GnRH)

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Ovitrelle® (hCG)

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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.

Intervention Type DRUG

Ovitrelle® (hCG)

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

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Decapeptyl 0.1 mg®

Eligibility Criteria

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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
Minimum Eligible Age

28 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Bernabeu

OTHER

Sponsor Role lead

Responsible Party

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Andrea Bernabeu García

Co-Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Instituto Bernabeu

Palma de Mallorca, Mallorca, Spain

Site Status RECRUITING

Instituto Bernabeu

Albacete, , Spain

Site Status RECRUITING

Instituto Bernabeu

Alicante, , Spain

Site Status RECRUITING

Instituto Bernabeu

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Anna Pitas, PhD

Role: CONTACT

+34663926079

Facility Contacts

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Anna Pitas, PhD

Role: primary

+34663926079

Anna Pitas, PhD

Role: primary

+34663926079

Anna Pitas, PhD

Role: primary

+34663926079

Anna Pitas, PhD

Role: primary

+34663926079

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.

Reference Type RESULT
PMID: 32208810 (View on PubMed)

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.

Reference Type RESULT
PMID: 27567429 (View on PubMed)

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.

Reference Type RESULT
PMID: 25311972 (View on PubMed)

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.

Reference Type RESULT
PMID: 30609935 (View on PubMed)

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.

Reference Type RESULT
PMID: 25296696 (View on PubMed)

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.

Reference Type RESULT
PMID: 28993105 (View on PubMed)

Other Identifiers

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IB-0121

Identifier Type: -

Identifier Source: org_study_id

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