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Not yet recruitingNCT06146413DoubtrigUpdated Nov 29, 2023

Triggering Oocyte Maturation in Normoresponders Using Double Trigger or HCG Trigger

A Phase 2 interventional study of Double trigger and HCG trigger in Infertility, sponsored by Bedaya Hospital. Not yet recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-11-29.

Sponsored by Bedaya Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
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Study 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.

Read the 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

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Conditions studied

  • Infertility

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Keywords

  • Infertility
  • IVF-ET
  • HCG trigger
  • Double trigger
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In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 150 is above the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Bedaya Hospital is the lead sponsor of 5 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Normoresponders
  • GnRH antagonist cycles

Exclusion criteria

Exclusion Criteria:

  • BMI more than 35
  • Endometriosis
  • AMH less than 1.1 ng
  • AMH more than 4
  • PCOS
  • Poor responders
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • 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

  • Active comparator
    HCG trigger

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

    Drug: HCG trigger

Interventions

  • DrugDouble trigger

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

    Also known as: Augmented trigger

  • DrugHCG trigger

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

    Also known as: Conventional trigger

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What researchers measure

Primary outcomes

  1. Metaphase-II oocytes rate

    Number of MII oocyte/ number of cumulus oocyte complex

    Time frame: Ten to fifteen days after starting ovarian stimulation

Secondary outcomes

  1. Clinical pregnancy rate

    Presence of intrauterine gestational sac detected by transvaginal ultrasound

    Time frame: 5 weeks after embryo transfer

  2. Ongoing Pregnancy Rate

    Pregnancies continued beyond 20 weeks gestation

    Time frame: 18 weeks after embryo transfer

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Study locations

1 site
08

References and documents

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. PubMed 25296696 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06146413
Lead sponsor
Bedaya Hospital
Responsible party
Usama M.Fouda (Clinical Professor, Bedaya Hospital) — Principal investigator
First posted
Nov 24, 2023
Start date
Dec 30, 2023 (estimated)
Primary completion
Mar 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Nov 29, 2023

Study contacts

Usama M Fouda, Prof.
Contact
umfrfouda@yahoo.com
+201095401375
Ismail Aboul Foutouh, Prof.
study chair · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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