Infertility (IVF Patients)Phase 2NCT07569302
Triggering Ovulation in Normo-responders Using a Modified Dual Trigger Protocol or HCG Trigger
A Phase 2 study testing Modified dual trigger and HCG in people with Infertility (IVF Patients), run by Bedaya Hospital at 1 site in Egypt.
Trial summary
The aim of this randomized controlled study is to compare the efficacy of a modified dual trigger protocol [a single bolos of HCG combined with two successive doses of a GnRH agonist ] with HCG [a single bolos administered 36 hours before oocyte retrieval ] in triggering ovulation in normo-responders undergoing… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility (IVF Patients)
- What is being tested?
- Modified dual trigger and HCG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 1 Apr 2028
- Phase
- Phase 2
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- GnRH antagonist IVF cycle
- Normo-responders to induction of ovulation
Who cannot join
- Hypogonadotrophic hypogonadism
- Endometriosis
- History of recurrent abortion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Bedaya Hospital
Giza, Giza Governorate, 3753303
Usama M Fouda, Prof, +201095401375, umfrfouda@yahoo.com
Amira Alasmar, M.D, PhD
About this study
Official title: Triggering Ovulation in Normo-responders Using a Modified Dual Trigger Protocol or HCG Trigger . A Randomized Controlled Study
The aim of this randomized controlled study is to compare the efficacy of a modified dual trigger protocol [a single bolos of HCG combined with two successive doses of a GnRH agonist ] with HCG [a single bolos administered 36 hours before oocyte retrieval ] in triggering ovulation in normo-responders undergoing ovarian stimulation using the antagonist protocol.
- Conditions
- Infertility (IVF Patients)
- Being tested
- Modified dual trigger, HCG
- Keywords
- Infertility, IVF-ET, Normo-responders, GnRH agonist, HCG
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified dual triggerDrug
HCG (10000 IU /IM) and triptorelin (0.2 mg/S.C) are administered 36 hours before ovum pickup . Moreover, 0.1mg of triptorelin is administered 24 h prior to ovum pick-up.
HCGDrug
HCG (10000 IU/IM ) is administered 36 hours before ovum pickup.
| Study group | Role | What they receive |
|---|---|---|
| Modified dual trigger group | Experimental | HCG is administered 36 hours before ovum pickup and two successive doses of GnRH are administered 36 and 24 hours before ovum pickup. Receives: Drug: Modified dual trigger |
| HCG group | Active comparator | A single dose of HCG is administered 36 hours before oocyte retrieval Receives: Drug: HCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metaphase-II oocytes rate
Number of MII oocyte/ number of cumulus oocyte complex
Measured: Ten to fifteen days after starting ovarian stimulation
Secondary outcomes (2)
Clinical pregnancy rate
Presence of intrauterine gestational sac detected by transvaginal ultrasound
Measured: Five weeks after embryo transfer
Ongoing pregnancy Rate
Pregnancies continued beyond 20 weeks gestation
Measured: Eighteen weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility (IVF Patients)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bedaya Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569302
- Sponsor's protocol ID
- Dual trigger/normo-responders
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triggering Ovulation in Normo-responders Using a Modified Dual Trigger Protocol or HCG Trigger . A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07569302
- Acronym / sponsor ID
- Dual trigger/normo-responders
- Conditions
- Infertility (IVF Patients)
- Keywords
- Infertility, IVF-ET, Normo-responders, GnRH agonist, HCG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Bedaya HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this randomized controlled study is to compare the efficacy of a modified dual trigger protocol [a single bolos of HCG combined with two successive doses of a GnRH agonist ] with HCG [a single bolos administered 36 hours before oocyte retrieval ] in triggering ovulation in normo-responders undergoing ovarian stimulation using the antagonist protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified dual trigger group | Experimental | Drug: Modified dual triggerHCG is administered 36 hours before ovum pickup and two successive doses of GnRH are administered 36 and 24 hours before ovum pickup. |
| HCG group | Active comparator | Drug: HCGA single dose of HCG is administered 36 hours before oocyte retrieval |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- GnRH antagonist IVF cycle
- Normo-responders to induction of ovulation
Key exclusion criteria (3 listed)
- Hypogonadotrophic hypogonadism
- Endometriosis
- History of recurrent abortion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified dual triggerHCG (10000 IU /IM) and triptorelin (0.2 mg/S.C) are administered 36 hours before ovum pickup . Moreover, 0.1mg of triptorelin is administered 24 h prior to ovum pick-up. | Drug | Modified dual trigger group |
| HCGHCG (10000 IU/IM ) is administered 36 hours before ovum pickup. | Drug | HCG group |
Primary outcome
Metaphase-II oocytes rate
Time frame: Ten to fifteen days after starting ovarian stimulation
Number of MII oocyte/ number of cumulus oocyte complex
2 secondary outcomes
Clinical pregnancy rate
Time frame: Five weeks after embryo transfer
Ongoing pregnancy Rate
Time frame: Eighteen weeks after embryo transfer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Modified dual trigger and HCG in people with Infertility (IVF Patients), run by Bedaya Hospital 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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 6 May 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Usama M Fouda, Prof (+201095401375, umfrfouda@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metaphase-II oocytes rate (time frame: Ten to fifteen days after starting ovarian stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2026.