Triggering Oocyte Maturation in Normoresponders Using Double Trigger or HCG Trigger

Phase 2

Not yet recruiting

• Conditions: Infertility
• Interventions: Drug: Double trigger; Drug: HCG trigger

• Registration Number: NCT06146413
• Lead Sponsor: Bedaya Hospital

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.

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 Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-19
• Study First Submitted QC: 2023-11-19
• Last Update Submitted: 2023-11-23
• Study First Posted: 2023-11-24
• Last Update Posted: 2023-11-29
• Study Start: 2023-12-30
• Primary Completion: 2025-03-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double trigger	Double trigger	GnRH agonist ( Triptorelin ) ( 0.2 mg / S.C ) and hCG ( 10000 IU) are administered 40 and 34 h before oocyte retrieval
HCG trigger	HCG trigger	HCG ( 100000 IU/ I.M ) is administered 36 h before oocyte retrieval

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Bedaya Hospital; 🇪🇬 Giza, Egypt