InfertilityPhase 2DoubtrigNCT06146413
Triggering Oocyte Maturation in Normoresponders Using Double Trigger or HCG Trigger
A Phase 2 study testing Double trigger and HCG trigger in people with Infertility, run by Bedaya Hospital at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Double trigger and HCG trigger
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2023to 30 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Normoresponders
- GnRH antagonist cycles
Who cannot join
- BMI more than 35
- Endometriosis
- AMH less than 1.1 ng
- AMH more than 4
- PCOS
- Poor responders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Triggering Oocyte Maturation in Normoresponders Using Double Trigger or HCG Trigger . A Randomized Controlled Trial
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
- Conditions
- Infertility
- Being tested
- Double trigger, HCG trigger
- Keywords
- Infertility, IVF-ET, HCG trigger, Double trigger
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double triggerDrug
Also called Augmented trigger
GnRH agonist ( Triptorelin ) ( 0.2 mg / S.C ) and hCG ( 10000 IU) are administered 40 and 34 h before ovum pick-up
HCG triggerDrug
Also called Conventional trigger
hCG ( 10000 IU) is administered 36 h before ovum pick-up
| Study group | Role | What they receive |
|---|---|---|
| Double trigger | Experimental | GnRH agonist ( Triptorelin ) ( 0.2 mg / S.C ) and hCG ( 10000 IU) are administered 40 and 34 h before oocyte retrieval Receives: Drug: Double trigger |
| HCG trigger | Active comparator | HCG ( 100000 IU/ I.M ) is administered 36 h before oocyte retrieval Receives: Drug: HCG trigger |
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: 5 weeks after embryo transfer
Ongoing Pregnancy Rate
Pregnancies continued beyond 20 weeks gestation
Measured: 18 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 posted24 Nov 2023
- Study start30 Dec 2023 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bedaya Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Usama M.Fouda, Bedaya Hospital
- Investigators
- Ismail Aboul Foutouh, Prof., Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146413
- Sponsor's protocol ID
- Double trigger in IVF
- Acronym
- Doubtrig
- Status last verified
- Nov 2023
- First submitted
- 19 Nov 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triggering Oocyte Maturation in Normoresponders Using Double Trigger or HCG Trigger . A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06146413
- Acronym / sponsor ID
- Doubtrig / Double trigger in IVF
- Conditions
- Infertility
- Keywords
- Infertility, IVF-ET, HCG trigger, Double trigger
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Bedaya HospitalUniversity, hospital or other
- Study start
- 30 Dec 2023 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 24 Nov 2023 (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 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double trigger | Experimental | Drug: Double triggerGnRH agonist ( Triptorelin ) ( 0.2 mg / S.C ) and hCG ( 10000 IU) are administered 40 and 34 h before oocyte retrieval |
| HCG trigger | Active comparator | Drug: HCG triggerHCG ( 100000 IU/ I.M ) is administered 36 h 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)
- Normoresponders
- GnRH antagonist cycles
Key exclusion criteria (6 listed)
- BMI more than 35
- Endometriosis
- AMH less than 1.1 ng
- AMH more than 4
- PCOS
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 |
|---|---|---|
| Double triggerAlso: Augmented triggerGnRH agonist ( Triptorelin ) ( 0.2 mg / S.C ) and hCG ( 10000 IU) are administered 40 and 34 h before ovum pick-up | Drug | Double trigger |
| HCG triggerAlso: Conventional triggerhCG ( 10000 IU) is administered 36 h before ovum pick-up | Drug | HCG trigger |
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: 5 weeks after embryo transfer
Ongoing Pregnancy Rate
Time frame: 18 weeks after embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Background: PubMed 25296696Haas 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.
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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. This study is not recruiting at the moment.
Ismail Aboul Foutouh, Prof. study chair
Cairo University
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 Double trigger and HCG trigger in people with Infertility, 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 6 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: status not confirmed, as of the sponsor's last update on 29 Nov 2023. 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?
Results are not available in the source record.
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?
On the ClinicalTrials.gov record for NCT06146413, which also lists 1 linked publication.
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 29 Nov 2023.