Infertility, FemalePhase 2NCT04407052
Double Trigger in Patients With Low Proportion of Mature Oocytes
A Phase 2 study testing Double trigger and HCG trigger in people with Infertility, Female, run by Riyadh Fertility and Reproductive Health center at 1 site in Egypt.
Trial summary
The aim of this randomized controlled trial is to determine whether co-administration of GnRH agonist and hCG for final oocyte maturation ( 40 and 34 h prior to oocyte retrieval , respectively) can increase the number of mature oocytes in patients with history of low proportion of mature oocytes in previous IVF cycle… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Double trigger and HCG trigger
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 30 May 2020to 2 Feb 2021
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with history of low proportion of mature oocytes in previous IVF attempt (triggered by HCG).
- Patients with 6 to 15 mature follicles on the day oocyte trigger in the current IVF-ET attempt
Who cannot join
- Endometriosis
- PCOS
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Riyadh Fertility and Reproductive Health center
Giza
Usama M Fouda, Prof., +201095401375, umfrfouda@yahoo.com
About this study
Official title: Double Trigger in Patients With Low Proportion of Mature Oocytes. A Randomized Controlled Trial
The aim of this randomized controlled trial is to determine whether co-administration of GnRH agonist and hCG for final oocyte maturation ( 40 and 34 h prior to oocyte retrieval , respectively) can increase the number of mature oocytes in patients with history of low proportion of mature oocytes in previous IVF cycle triggered by HCG.
- Conditions
- Infertility, Female
- Being tested
- Double trigger, HCG trigger
- Keywords
- IVF, HCG, GnRH agonist trigger
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double triggerDrug
Final follicular maturation is triggered by the coadministration of GnRH-agonist (Triptorelin acetate, decapeptyl 0.2 mg, Slough, United Kingdom) and 10000 IU of HCG, 40 and 34 h prior to oocyte retrieval, respectively
HCG triggerDrug
Final follicular maturation is triggered by a dose of 10000 IU of HCG 36 h prior to oocyte retrieval
| Study group | Role | What they receive |
|---|---|---|
| Double trigger | Experimental | GnRH-agonist and HCG are used to trigger ovulation Receives: Drug: Double trigger |
| HCG | Active comparator | HCG is used to trigger ovulation Receives: Drug: HCG trigger |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oocytes retrieved
Measured: First day after oocyte retrieval
Secondary outcomes (1)
Clinical pregnancy rate
The presence of gestational sac detected by ultrasound examination
Measured: First 5 weeks after oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start30 May 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion2 Feb 2021 (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 Infertility, FemaleStudies 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
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riyadh Fertility and Reproductive Health center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Usama M Fouda, Prof., Study chair, Riyadh Fertility and Reproductive Health center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407052
- Sponsor's protocol ID
- Double trigger/mature oocytes
- Status last verified
- May 2020
- First submitted
- 25 May 2020
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zilberberg E, Haas J, 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 proportion of mature oocytes. Gynecol Endocrinol. 2015 Feb;31(2):145-7. doi: 10.3109/09513590.2014.978850. Epub 2014 Nov 11.
PubMed 25385007
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Trigger in Patients With Low Proportion of Mature Oocytes. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04407052
- Acronym / sponsor ID
- Double trigger/mature oocytes
- Conditions
- Infertility, Female
- Keywords
- IVF, HCG, GnRH agonist trigger
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Riyadh Fertility and Reproductive Health centerUniversity, hospital or other
- Study start
- 30 May 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 2 Feb 2021 (estimated)
- First posted
- 29 May 2020 (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 trial is to determine whether co-administration of GnRH agonist and hCG for final oocyte maturation ( 40 and 34 h prior to oocyte retrieval , respectively) can increase the number of mature oocytes in patients with history of low proportion of mature oocytes in previous IVF cycle triggered by HCG.
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 and HCG are used to trigger ovulation |
| HCG | Active comparator | Drug: HCG triggerHCG is used to trigger ovulation |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with history of low proportion of mature oocytes in previous IVF attempt (triggered by HCG).
- Patients with 6 to 15 mature follicles on the day oocyte trigger in the current IVF-ET attempt
Key exclusion criteria (2 listed)
- Endometriosis
- 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 triggerFinal follicular maturation is triggered by the coadministration of GnRH-agonist (Triptorelin acetate, decapeptyl 0.2 mg, Slough, United Kingdom) and 10000 IU of HCG, 40 and 34 h prior to oocyte retrieval, respectively | Drug | Double trigger |
| HCG triggerFinal follicular maturation is triggered by a dose of 10000 IU of HCG 36 h prior to oocyte retrieval | Drug | HCG |
Primary outcome
Number of oocytes retrieved
Time frame: First day after oocyte retrieval
1 secondary outcome
Clinical pregnancy rate
Time frame: First 5 weeks after oocyte retrieval
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Background: PubMed 25385007Zilberberg E, Haas J, 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 proportion of mature oocytes. Gynecol Endocrinol. 2015 Feb;31(2):145-7. doi: 10.3109/09513590.2014.978850. Epub 2014 Nov 11.
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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.
Usama M Fouda, Prof. study chair
Riyadh Fertility and Reproductive Health center
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, Female, run by Riyadh Fertility and Reproductive Health center 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 2 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 May 2020. 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?
Number of oocytes retrieved (time frame: First day after oocyte 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 NCT04407052, 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 May 2020.