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CompletedNCT04224818Updated Jul 23, 2021

Dual Trigger in the Final Oocyte Maturation in Poor Ovarian Responders

A Phase 3 interventional study of Dual trigger and hCG (standard) in Poor Ovarian Reserve, sponsored by American University of Beirut Medical Center. Completed at 1 site in Lebanon. Open to female participants aged 18 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-23.

Sponsored by American University of Beirut Medical Center · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jul 2018, registered Sep 2019).
Phase
Phase 3
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years to 44 Years
Sex
Female
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Study summary

This is a randomized controlled clinical trial to investigate the effect of dual trigger (hCG and GnRH agonist) on the final oocyte maturation compared to the standard hCG trigger in patients with poor ovarian reserve seeking IVF/ICSI treatment.

Read the detailed description

Women with POR (Bologna criteria) manifest a very low follicular response to controlled ovarian stimulation irrespective of the stimulation protocol utilized. Dual triggering of oocyte maturation was shown to improve follicle collection yield and oocyte maturation in women with predicted normal ovarian response. These benefits have been attributed to the GnRHa-induced FSH surge believed to promote oocyte nuclear maturation and cumulus expansion. The aim of the study is to show whether the co-administration of a GnRH agonist and hCG for final oocyte maturation improve oocyte collection and maturation rate

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Conditions studied

  • Poor Ovarian Reserve
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In context

Lead sponsor

American University of Beirut Medical Center is the lead sponsor of 152 studies on the registry; 27 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 44 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Normal uterine cavity (as assessed by hysteroscopy or HSG).
  • Normal hormonal investigation: TSH, PRL.
  • Low ovarian reserve patients (AMH\<1.5ng/ml, AFC of 7 or less, 5 oocytes or less retrieved in a previous cycle)

Exclusion criteria

Exclusion Criteria:

  • Abnormal uterine cavity (Hysteroscopy or HSG)
  • Evidence of untreated endocrine disorders (abnormal TSH, prolactin, testosterone and androstenedione concentrations)
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (actual)

Study arms

  • Experimental
    Dual trigger

    Dual trigger: (0.3 mg GnRHa = triptorelin) with + HCG (Choriomon)10 000 IU . will be administered subcutaneously in a single dose 0.3 mg with 10 000 HCG when at least 2 follicles 18 mm in diameter have been observed by ultrasound examination.

    Drug: Dual trigger

  • Active comparator
    hCG (standard)

    HCG (Choriomon) of 10 000 IU will be administered subcutaneously in a single dose when at least 2 follicles 18 mm in diameter have been observed by ultrasound examination.

    Drug: hCG (standard)

Interventions

  • DrugDual trigger

    Dual trigger: human Chorionic Gonadotropin (Choriomon 10,000 IU subcutaneous once) + Gonadotropin-Releasing Hormone agonist (Triptorelin 0.3 mg subcutaneous once)

    Also known as: Dual ovulation trigger (Choriomon and Triptorelin)

  • DrughCG (standard)

    human Chorionic Gonadotropin (Choriomon 10,000 IU subcutaneous once)

    Also known as: human Chorionic Gonadotropin

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What researchers measure

Primary outcomes

  1. Number of oocytes retrieved (oocyte collection rate)

    the total number of oocytes retrieved divided by the number of follicles aspirated (diameter ≥10 mm) on the day of oocyte retrieval

    Time frame: 38 hrs

  2. Number of mature oocytes (oocyte maturation rate)

    the ratio of MII oocytes to the number of collected oocytes

    Time frame: 38 hrs

Secondary outcomes

  1. Fertilization rate

    the ratio of normal fertilized oocytes (2PN) to the number of oocytes used for fertilization

    Time frame: 48 hrs

  2. Clinical pregnancy rate

    the presence of fetal cardiac activity confirmed by transvaginal ultrasound 7 weeks after embryo transfer

    Time frame: 7 weeks

  3. Implantation rate

    the number of gestational sacs visualized on ultrasound examination divided by the number of embryos transferred

    Time frame: 7 weeks

  4. Miscarriage rate

    the spontaneous loss of a clinical pregnancy occurring before 12 completed weeks of gestational age

    Time frame: 12 weeks

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Study locations

1 site
  • American University of Beirut Medical Center
    Beirut, Lebanon
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2021, 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
NCT04224818
Lead sponsor
American University of Beirut Medical Center
Responsible party
Sponsor
First posted
Jan 13, 2020
Start date
Jul 11, 2018
Primary completion
Aug 20, 2019
Completion
Aug 30, 2019
Last update
Jul 23, 2021

Study contacts

Ghina S Ghazeeri, MD
principal investigator · American University of Beirut Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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