Triggering Oocyte Maturation in POSEIDON Group 3 and 4 Poor Responders Using Double Trigger or HCG Trigger

Triggering Oocyte Maturation in POSEIDON Group 3 and 4 Poor Responders Using Double Trigger or HCG Trigger . A Randomized Controlled Study

The aim of this randomized controlled study is to compare the efficacy of double trigger protocol [ the co-administration of GnRH agonist with HCG ( 38 - 39 and 35 - 36 h prior to ovum pick-up, respectively ] with HCG in triggering ovulation in patients with expected poor response to ovarian stimulation

Study Overview

• Status: Not yet recruiting
• Conditions: Infertility
• Intervention / Treatment: Drug: Double trigger; Drug: HCG trigger

• Study Type: Interventional
• Enrollment (Estimated): 164
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Usama M Fouda, Prof.; Phone Number: +201095401375; Email: umfrfouda@yahoo.com

Study Locations

• Egypt
  • Giza Governorate
    • Giza, Giza Governorate, Egypt, 3753303
      • Bedaya Hospital
      • Contact: Usama M Fouda, Prof; Phone Number: +201095401375; Email: umfrfouda@yahoo.com
      • Principal Investigator: Reham Elkhalifa, M.D, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• POSEIDON group 3 and 4
• GnRH antagonist IVF cycle

Exclusion Criteria:

• Hypogonadotrophic hypogonadism
• Endometriosis
• History of recurrent abortion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Double trigger; GnRH agonist is administered 38 - 39 hours prior to ovum pick-up and HCG is administered 35 - 36 hours prior to ovum pick-up, respectively.	Drug: Double trigger; Triptorelin (0.2 mg/S.C ) and HCG (10000 IU/I.M) are administered 38 to 39 h and 35 to 36 h prior to ovum pick-up., respectively.
Active Comparator: HCG trigger; HCG is administered 35 - 36 h prior to ovum pick-up	Drug: HCG trigger; HCG (10000 IU/I.M) is administered 35 to 36 h prior to ovum pick-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metaphase-II oocytes rate	Number of MII oocyte/ number of cumulus oocyte complex	Ten to fifteen days after starting ovarian stimulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical pregnancy rate	Presence of intrauterine gestational sac detected by transvaginal ultrasound	Five weeks after embryo transfer
Ongoing pregnancy Rate	Pregnancies continued beyond 20 weeks gestation	Eighteen weeks after embryo transfer

Collaborators and Investigators

• Sponsor: Bedaya Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Infertility; GnRH agonist; IVF-ET; Poor responders; HCG; Double trigger
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: Double trigger/Poor responder

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No