Doubtrig: Triggering Oocyte Maturation in Normoresponders Using Double Trigger or HCG Trigger

Sponsor

Bedaya Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06146413

Collaborator

(none)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: Double trigger Drug: HCG trigger	Phase 2

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Triggering Oocyte Maturation in Normoresponders Using Double Trigger or HCG Trigger . A Randomized Controlled Trial

Anticipated Study Start Date :

Dec 30, 2023

Anticipated Primary Completion Date :

Mar 30, 2025

Anticipated Study Completion Date :

Dec 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Double trigger GnRH agonist ( Triptorelin ) ( 0.2 mg / S.C ) and hCG ( 10000 IU) are administered 40 and 34 h before oocyte retrieval	Drug: Double trigger GnRH agonist ( Triptorelin ) ( 0.2 mg / S.C ) and hCG ( 10000 IU) are administered 40 and 34 h before ovum pick-up Other Names: Augmented trigger
Active Comparator: HCG trigger HCG ( 100000 IU/ I.M ) is administered 36 h before oocyte retrieval	Drug: HCG trigger hCG ( 10000 IU) is administered 36 h before ovum pick-up Other Names: Conventional trigger

Arm

Intervention/Treatment

Experimental: Double trigger

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

Drug: Double trigger

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

Other Names:

Augmented trigger

Active Comparator: HCG trigger

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

Drug: HCG trigger

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

Other Names:

Conventional trigger

Outcome Measures

Primary Outcome Measures

Metaphase-II oocytes rate [Ten to fifteen days after starting ovarian stimulation]
Number of MII oocyte/ number of cumulus oocyte complex

Secondary Outcome Measures

Clinical pregnancy rate [5 weeks after embryo transfer]
Presence of intrauterine gestational sac detected by transvaginal ultrasound
Ongoing Pregnancy Rate [18 weeks after embryo transfer]
Pregnancies continued beyond 20 weeks gestation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bedaya Hospital	Giza		Egypt

Sponsors and Collaborators

Bedaya Hospital

Investigators

Study Chair: Ismail Aboul Foutouh, Prof., Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Usama M.Fouda, Clinical Professor, Bedaya Hospital

ClinicalTrials.gov Identifier:

NCT06146413

Other Study ID Numbers:

Double trigger in IVF

First Posted:

Nov 24, 2023

Last Update Posted:

Nov 29, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Usama M.Fouda, Clinical Professor, Bedaya Hospital

Additional relevant MeSH terms:

Infertility

Study Results

No Results Posted as of Nov 29, 2023