Poor Ovarian ReservePhase 3NCT04224818
Dual Trigger in the Final Oocyte Maturation in Poor Ovarian Responders
A Phase 3 study testing Dual trigger and hCG (standard) in people with Poor Ovarian Reserve, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Poor Ovarian Reserve
- What is being tested?
- Dual trigger and hCG (standard)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteLebanon
- Study dates
- 11 Jul 2018to 30 Aug 2019
- Phase
- Phase 3
- 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 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- Abnormal uterine cavity (Hysteroscopy or HSG)
- Evidence of untreated endocrine disorders (abnormal TSH, prolactin, testosterone and androstenedione concentrations)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dual Trigger in the Final Oocyte Maturation in Poor Ovarian Responders: A Prospective Randomized Controlled Trial
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
- Conditions
- Poor Ovarian Reserve
- Being tested
- Dual trigger, hCG (standard)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual triggerDrug
Also called Dual ovulation trigger (Choriomon and Triptorelin)
Dual trigger: human Chorionic Gonadotropin (Choriomon 10,000 IU subcutaneous once) + Gonadotropin-Releasing Hormone agonist (Triptorelin 0.3 mg subcutaneous once)
hCG (standard)Drug
Also called human Chorionic Gonadotropin
human Chorionic Gonadotropin (Choriomon 10,000 IU subcutaneous once)
| Study group | Role | What they receive |
|---|---|---|
| Dual trigger | Experimental | 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. Receives: Drug: Dual trigger |
| hCG (standard) | Active comparator | 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. Receives: Drug: hCG (standard) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 38 hrs
Number of mature oocytes (oocyte maturation rate)
the ratio of MII oocytes to the number of collected oocytes
Measured: 38 hrs
Secondary outcomes (4)
Fertilization rate
the ratio of normal fertilized oocytes (2PN) to the number of oocytes used for fertilization
Measured: 48 hrs
Clinical pregnancy rate
the presence of fetal cardiac activity confirmed by transvaginal ultrasound 7 weeks after embryo transfer
Measured: 7 weeks
Implantation rate
the number of gestational sacs visualized on ultrasound examination divided by the number of embryos transferred
Measured: 7 weeks
Miscarriage rate
the spontaneous loss of a clinical pregnancy occurring before 12 completed weeks of gestational age
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start11 Jul 2018
- Primary completion20 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Ovarian ReserveStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ghina S Ghazeeri, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224818
- Sponsor's protocol ID
- BIO-2018-0020
- Status last verified
- Jan 2021
- First submitted
- 20 Sep 2019
- Last updated
- 23 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Trigger in the Final Oocyte Maturation in Poor Ovarian Responders: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04224818
- Acronym / sponsor ID
- BIO-2018-0020
- Conditions
- Poor Ovarian Reserve
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 13 Jan 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.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual trigger | Experimental | Drug: Dual triggerDual 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. |
| hCG (standard) | Active comparator | Drug: 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. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Abnormal uterine cavity (Hysteroscopy or HSG)
- Evidence of untreated endocrine disorders (abnormal TSH, prolactin, testosterone and androstenedione concentrations)
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 |
|---|---|---|
| Dual triggerAlso: Dual ovulation trigger (Choriomon and Triptorelin)Dual trigger: human Chorionic Gonadotropin (Choriomon 10,000 IU subcutaneous once) + Gonadotropin-Releasing Hormone agonist (Triptorelin 0.3 mg subcutaneous once) | Drug | Dual trigger |
| hCG (standard)Also: human Chorionic Gonadotropinhuman Chorionic Gonadotropin (Choriomon 10,000 IU subcutaneous once) | Drug | hCG (standard) |
Primary outcome
Number of oocytes retrieved (oocyte collection rate)
Time frame: 38 hrs
the total number of oocytes retrieved divided by the number of follicles aspirated (diameter ≥10 mm) on the day of oocyte retrieval
Number of mature oocytes (oocyte maturation rate)
Time frame: 38 hrs
the ratio of MII oocytes to the number of collected oocytes
4 secondary outcomes
Fertilization rate
Time frame: 48 hrs
Clinical pregnancy rate
Time frame: 7 weeks
Implantation rate
Time frame: 7 weeks
Miscarriage rate
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
Related trials for Poor Ovarian Reserve
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Drospirenone-Primed Ovarian Stimulation Versus GnRH Antagonist Protocol in Poor Ovarian Responders Undergoing Freeze-All IVF/ICSI
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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.
Ghina S Ghazeeri, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dual trigger and hCG (standard) in people with Poor Ovarian Reserve, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 3 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: finished, as of the sponsor's last update on 23 Jul 2021. 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 Lebanon. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of oocytes retrieved (oocyte collection rate) (time frame: 38 hrs). The study lists 2 primary outcomes in all. 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 23 Jul 2021.