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Triggering Oocyte Maturation in Normoresponders Using Double Trigger or HCG Trigger

NCT ID: NCT06146413

Last Updated: 2023-11-29

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

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-30

Study Completion Date

2025-12-30

Brief Summary

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The aim of this study is to compare the efficacy double trigger \[ co-administration of GnRH agonist with HCG 40 and 34 h prior to ovum pick-up, respectively\] with HCG trigger in inducing oocyte maturation.

Detailed Description

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Several studies revealed that the double trigger regimen was effective in the treatment of patients with a history of immature oocytes retrieved or with suboptimal oocytes yield.

The investigators designed this randomized controlled trial to compare the efficacy double trigger with HCG trigger in inducing oocyte maturation.in normoreponders undergoing IVF-ET

Conditions

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Infertility

Keywords

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Infertility IVF-ET HCG trigger Double trigger

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Double trigger

GnRH agonist ( Triptorelin ) ( 0.2 mg / S.C ) and hCG ( 10000 IU) are administered 40 and 34 h before oocyte retrieval

Group Type EXPERIMENTAL

Double trigger

Intervention Type DRUG

GnRH agonist ( Triptorelin ) ( 0.2 mg / S.C ) and hCG ( 10000 IU) are administered 40 and 34 h before ovum pick-up

HCG trigger

HCG ( 100000 IU/ I.M ) is administered 36 h before oocyte retrieval

Group Type ACTIVE_COMPARATOR

HCG trigger

Intervention Type DRUG

hCG ( 10000 IU) is administered 36 h before ovum pick-up

Interventions

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Double trigger

GnRH agonist ( Triptorelin ) ( 0.2 mg / S.C ) and hCG ( 10000 IU) are administered 40 and 34 h before ovum pick-up

Intervention Type DRUG

HCG trigger

hCG ( 10000 IU) is administered 36 h before ovum pick-up

Intervention Type DRUG

Other Intervention Names

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Augmented trigger Conventional trigger

Eligibility Criteria

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Inclusion Criteria

* Normoresponders
* GnRH antagonist cycles

Exclusion Criteria

* BMI more than 35
* Endometriosis
* AMH less than 1.1 ng
* AMH more than 4
* PCOS
* Poor responders
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bedaya Hospital

OTHER

Sponsor Role lead

Responsible Party

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Usama M.Fouda

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ismail Aboul Foutouh, Prof.

Role: STUDY_CHAIR

Cairo University

Locations

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Bedaya Hospital

Giza, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Usama M Fouda, Prof.

Role: CONTACT

Phone: +201095401375

Email: [email protected]

Facility Contacts

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Usama M. Fouda, Prof

Role: primary

References

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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 BACKGROUND
PMID: 25296696 (View on PubMed)

Other Identifiers

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Double trigger in IVF

Identifier Type: -

Identifier Source: org_study_id