AzTrials
AzTrials

ICSIDT-HCG-IVFNCT07861399

Dual Trigger VS HCG Trigger for Final Oocyte Maturation in Normal Responders

A study testing Dual trigger (human chorionic gonadotropin plus GnRH-agonist) and hCG trigger in people with ICSI and IVF, run by Al-Azhar University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

To compare the embryological and reproductive outcomes of dual trigger versus conventional hCG trigger for final oocyte maturation in normal responder patients undergoing ICSI cycles. Read more about this study

Who is it for?
Ages 20 to 40 years, women only
Conditions the study is for
ICSI, IVF, Normal Responders
What is being tested?
Dual trigger (human chorionic gonadotropin plus GnRH-agonist) and hCG trigger
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteEgypt
Study dates
1 Sep 2026to Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Women aged 20-40 years.
  • Body mass index (BMI) between 18 and 30 kg/m².
  • Undergoing ICSI treatment using a GnRH antagonist protocol.
  • Normal ovarian reserve and expected normal ovarian response.
  • AMH between 1.2 - 3.5 ng/ml
  • AFC 7-15 follicle.
  • First or second ICSI cycle.

Who cannot join

  • Poor ovarian response (Bologna/POSEIDON criteria)
  • High ovarian response with a risk of ovarian hyperstimulation syndrome (OHSS) AMH > 3.5 ng/ml or AFC > 15 follicle.
  • Polycystic ovary syndrome (PCOS).
  • Serum E2 level > 3500 pg/ml at day of triggering.
  • Endocrine disorders including diabetes mellitus, thyroid dysfunction, hyperprolactinemia, congenital adrenal hyperplasia, or Cushing syndrome.
  • Congenital uterine abnormalities.
  • Severe systemic diseases affecting fertility outcomes.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ahmed MM Gebreel, MSc contact

+201092576506

agebreel@hotmail.com

Egypt1 site, 1 recruiting

  • ART Unit, International Islamic Center for Population Studies and Research, Al-Azhar University

    Cairo, Cairo Governorate

    Administration Office, +201066634172, iicpsr_azhar2@hotmail.com

    Ahmed MM Gebreel, MSc.

    Recruiting

Other trials in Egypt

About this study

Official title: Dual Trigger VS HCG Trigger for Final Oocyte Maturation in Normal Responders a Randomized Controlled Trial

To compare the embryological and reproductive outcomes of dual trigger versus conventional hCG trigger for final oocyte maturation in normal responder patients undergoing ICSI cycles.

Read the detailed description

To compare the embryological and reproductive outcomes of dual trigger versus conventional hCG trigger for final oocyte maturation in normal responder patients undergoing ICSI cycles.

  • Dual Trigger Group: Participants will receive a GnRH agonist combined with hCG.
  • hCG Trigger Group: Participants will receive hCG alone. primary Outcomes

The following primary outcomes will be assessed:

  • Number of mature (MII) oocytes (assessment at denudation). Secondary Outcomes

The following secondary outcomes will be assessed:

  • Number of retrieved oocytes.
  • Fertilization rate.
  • Number and quality of embryos.
  • Implantation rate.
  • Clinical pregnancy rate.
  • Multiple pregnancy rate.
  • Incidence of ovarian hyperstimulation syndrome (OHSS).
Being tested
Dual trigger (human chorionic gonadotropin plus GnRH-agonist), hCG trigger
Keywords
icsi, ivf, dual trigger, hcg trigger, infertility, ART, normal responders, oocyte maturation
Medical subject headings
Long Qt Syndrome 3, Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dual trigger (human chorionic gonadotropin plus GnRH-agonist)Drug

    Also called Triptorelin acetate and human chorionic gonadotropin

    Dual Trigger Group: Participants will receive a GnRH agonist combined with hCG for normal responders patients doing ICSI.

  • hCG triggerDrug

    Also called human chorionic gonadotropin

    hCG Trigger Group: Participants will receive hCG alone the standard for normal responders doing ICSI.

Study groups in NCT07861399
Study groupRoleWhat they receive
Dual TriggerExperimentalDual Trigger Group: Participants will receive a GnRH agonist combined with hCG
Receives: Drug: Dual trigger (human chorionic gonadotropin plus GnRH-agonist)
HCG TriggerActive comparatorHCGTrigger Group: Participants will receive hCG alone.
Receives: Drug: hCG trigger

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oocytes Maturation

    Percentage of retrieved oocytes that are at the metaphase II (MII) stage.

    Measured: From oocyte retrieval until completion of oocyte assessment, approximately 0-2 hours after retrieval.

Secondary outcomes (6)

  1. Number of MII oocytes

    Number of metaphase II oocytes retrieved

    Measured: At oocyte retrieval (Day 0), approximately 0-2 hours after oocyte pick up.

  2. Number of oocytes retrieved

    Total number of oocytes retrieved during oocyte retrieval.

    Measured: Day of oocyte retrieval (Day 0) after oocyte retrieval.

  3. Fertilization rate

    Percentage of normally fertilized mature oocytes (2PN)

    Measured: Approximately 16-18 hours after insemination/ICSI

  4. Embryo utilization rate

    Percentage of normally fertilized oocytes resulting in embryos suitable for transfer or cryopreservation

    Measured: Day 3-5 after oocyte retrieval

  5. Clinical pregnancy rate

    Percentage of embryo transfer cycles resulting in an intrauterine gestational sac with fetal cardiac activity

    Measured: Approximately 5-7 weeks after embryo transfer

  6. Incidence of ovarian hyperstimulation syndrome (OHSS)

    Proportion of participants developing OHSS following controlled ovarian stimulation and oocyte retrieval, classified according to predefined diagnostic/severity criteria.

    Measured: From the day of trigger administration until 14 days after oocyte retrieval

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2026
  2. Study start1 Sep 2026
  3. Primary completionAug 2028 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Clinical Trial comparing two parallel groups receiving different ovulation triggering options during ICSI cycle
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07861399
Sponsor's protocol ID
Obs-Gyn-1000/2026/07/0020
Acronym
DT-HCG-IVF
Status last verified
Oct 2026
First submitted
27 Sep 2026
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: raw data and master sheet can be shared

Publications

  • Chung RK, Mancuso AC, Summers KM, Sparks AE, Duran HE, Mejia RB. Dual trigger protocol is an effective in vitro fertilization strategy in both normal and high responders without compromising pregnancy outcomes in fresh cycles. F S Rep. 2021 May 27;2(3):314-319. doi: 10.1016/j.xfre.2021.05.008. eCollection 2021 Sep.

    PubMed 34553157

  • Gao F, Wang Y, Fu M, Zhang Q, Ren Y, Shen H, Han H. Effect of a "Dual Trigger" Using a GnRH Agonist and hCG on the Cumulative Live-Birth Rate for Normal Responders in GnRH-Antagonist Cycles. Front Med (Lausanne). 2021 May 25;8:683210. doi: 10.3389/fmed.2021.683210. eCollection 2021.

    PubMed 34113641

  • Albeitawi S, Marar EA, Reshoud FA, Hamadneh J, Hamza R, Alhasan G, Omeish H, Vigano P. Dual trigger with gonadotropin-releasing hormone agonist and human chorionic gonadotropin significantly improves oocyte yield in normal responders on GnRH-antagonist cycles. JBRA Assist Reprod. 2022 Jan 17;26(1):28-32. doi: 10.5935/1518-0557.20210039.

    PubMed 34463444

  • Yan MH, Cao JX, Hou JW, Jiang WJ, Wang DD, Sun ZG, Song JY. GnRH Agonist and hCG (Dual Trigger) Versus hCG Trigger for Final Oocyte Maturation in Expected Normal Responders With a High Immature Oocyte Rate: Study Protocol for a Randomized, Superiority, Parallel Group, Controlled Trial. Front Endocrinol (Lausanne). 2022 Mar 28;13:831859. doi: 10.3389/fendo.2022.831859. eCollection 2022.

    PubMed 35418945

  • Zhou X, Guo P, Chen X, Ye D, Liu Y, Chen S. Comparison of dual trigger with combination GnRH agonist and hCG versus hCG alone trigger of oocyte maturation for normal ovarian responders. Int J Gynaecol Obstet. 2018 Jun;141(3):327-331. doi: 10.1002/ijgo.12457. Epub 2018 Feb 21.

    PubMed 29388691

  • Andersen CY, Kelsey T, Mamsen LS, Vuong LN. Shortcomings of an unphysiological triggering of oocyte maturation using human chorionic gonadotropin. Fertil Steril. 2020 Aug;114(2):200-208. doi: 10.1016/j.fertnstert.2020.05.022. Epub 2020 Jul 9.

    PubMed 32654823

  • Eftekhar M, Mojtahedi MF, Miraj S, Omid M. Final follicular maturation by administration of GnRH agonist plus HCG versus HCG in normal responders in ART cycles: An RCT. Int J Reprod Biomed. 2017 Jul;15(7):429-434.

    PubMed 29177244

Questions about this trial

What is this clinical trial studying?

A study testing Dual trigger (human chorionic gonadotropin plus GnRH-agonist) and hCG trigger in people with ICSI and IVF, run by Al-Azhar University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ahmed MM Gebreel, MSc (+201092576506, agebreel@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oocytes Maturation (time frame: From oocyte retrieval until completion of oocyte assessment, approximately 0-2 hours after retrieval.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07861399, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in