Ovarian StimulationNCT06142708
The Effect of Dual Trigger (GnRH Agonist + hCG) for Final Maturation in Oocyte Donors With History of a Previous Cycle With Suboptimal Response to GnRH Agonist Only Trigger
A study testing Dual trigger (human chorionic gonadotropin plus GnRH-agonist) and GnRH-agonist only trigger in people with Ovarian Stimulation and Human Chorionic Gonadotropin, run by Embryolab Fertility Clinic at 1 site in Greece.
Trial summary
The goal of this clinical trial is to compare GnRH-agonist trigger with dual GnRH-agonist and HCG trigger in oocyte donors. The main questions it aims to answer are: Maturation rate (Metaphase II/ Total number of COCs collected) Fertilization rate Embryo quality day 3 Fragmentation rate embryo day 3 Blastulation rate… Read more about this study
- Who is it for?
- Ages 20 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Stimulation, Human Chorionic Gonadotropin, Oocyte Donors
- What is being tested?
- Dual trigger (human chorionic gonadotropin plus GnRH-agonist) and GnRH-agonist only trigger
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGreece
- Study dates
- 1 Nov 2023to Feb 2026
- Phase
- Interventional
- 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 20 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI: 18 - 25
- AMH: 1-3ng/ml
- AFC: 15
- Peak E2 in previous ovarian stimulation cycle: < 4000 pg/ml
- Ovarian response in first stimulation cycle: < 20 follicles over 10mm in total, at time of triggering
- Peak E2 in study cycle: < 4000 pg/ml
- Suboptimal response to trigger medication at first stimulation cycle
- Male age < 50 years old with normospermia
Who cannot join
- Oocyte donors which are at risk for development of ovarian hyperstimulation syndrome (OHSS)
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Embryolab Fertility Clinic
Thessaloniki, 55133
Nikolaos Christoforidis, MD, +302310474747, n.christoforidis@embryolab.eu
Dimitrios Michalakis, MD, d.michalakis@embryolab.eu
About this study
The goal of this clinical trial is to compare GnRH-agonist trigger with dual GnRH-agonist and HCG trigger in oocyte donors.
The main questions it aims to answer are:
- Maturation rate (Metaphase II/ Total number of COCs collected)
- Fertilization rate
- Embryo quality day 3
- Fragmentation rate embryo day 3
- Blastulation rate (Day5/6/7)
- Quality of blastocyst (Gardner criteria) Participants will undergo controlled ovarian stimulation with a GnRH antagonist protocol Researchers will compare the effects of final maturation with GnRH-agonist trigger to a dual trigger (hCG and GnRH-a)
Read the detailed description
Final oocyte maturation is a critical step in the process of the Assisted Reproductive Technology (ART) treatment and has a certain impact on oocyte yield and oocyte competency. There are three different types of trigger: hCG, GnRH-agonist or dual trigger (hCG and GnRH-agonist combined), and the choice depends on the ovarian stimulation protocol, the ovarian response and on the clinical standard of the IVF clinic. As oocyte donors are at high risk for OHSS, a GnRH-agonist trigger (GnRH-a) is the most commonly used modality for triggering final maturation. However, a certain number of oocyte donors may have a suboptimal response to GnRH-a trigger only, with a yield of oocytes less than the 10th percentile, with a clear negative impact on oocyte efficiency and competency. This study aims to evaluate whether oocyte competence can be improved in oocyte donors with a previously suboptimal response to GnRH-a, by using a dual trigger in a subsequent ovarian stimulation cycle, in which hCG is added to the GnRH-agonist for final maturation
- Being tested
- Dual trigger (human chorionic gonadotropin plus GnRH-agonist), GnRH-agonist only trigger
- Keywords
- GnRH agonist, Dual trigger, Oocyte Donors
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
Human chorionic gonadotropin will be added to GnRH-agonist as a dual trigger in participants previously having had a suboptimal response to GnRH-agonist trigger only
GnRH-agonist only triggerDrug
GnRH-agonist only will be used for final maturation
| Study group | Role | What they receive |
|---|---|---|
| Dual trigger (GnRH-agonist plus hCG) | Experimental | Participants in this arm will be administered a GnRH-agonist trigger plus hCG (dual trigger) for final maturation Receives: Drug: Dual trigger (human chorionic gonadotropin plus GnRH-agonist) |
| Gn-RH-agonist only trigger | Active comparator | Participants in this arm will be administered a GnRH-agonist trigger only for final maturation Receives: Drug: GnRH-agonist only trigger |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oocyte maturation rate
Number of metaphase II oocytes per total number of oocytes retrieved in oocyte pick-up day
Measured: 18 months prospective trial
Fertilization rate
number of 2PN embryos per total number of MII oocytes fertilised
Measured: 18 months prospective trial
Blastulation rate
Number of blastocysts up to day 6 per number of fertilised 2PN embryos
Measured: 18 months prospective trial
Secondary outcomes (3)
Number of recipients per donor cycle
The number of recipients matched per donor
Measured: 18 months prospective trial
Ongoing Pregnancy Rate
number of pregnancies with positive fetal heart per number of embryotransfers performed
Measured: 28 months prospective trial
Live Birth Rate
number of live births per number of embryotransfers performed
Measured: 28 months prospective trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start1 Nov 2023
- Primary completionApr 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian StimulationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Embryolab Fertility Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- ART Fertility Clinics LLC
- Responsible party
- Principal investigator, Nikolaos Christoforidis, Embryolab Fertility Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142708
- Sponsor's protocol ID
- 012023
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the trial completion IPD are to be shared with researchers from ART Fertility Clinics for statistical analysis
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dual Trigger (GnRH Agonist + hCG) for Final Maturation in Oocyte Donors With History of a Previous Cycle With Suboptimal Response to GnRH Agonist Only Trigger
- ClinicalTrials.gov ID
- NCT06142708
- Acronym / sponsor ID
- 012023
- Keywords
- GnRH agonist, Dual trigger, Oocyte Donors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Embryolab Fertility ClinicUniversity, hospital or other
- Collaborators
- ART Fertility Clinics LLC
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 21 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 goal of this clinical trial is to compare GnRH-agonist trigger with dual GnRH-agonist and HCG trigger in oocyte donors.
The main questions it aims to answer are:
- Maturation rate (Metaphase II/ Total number of COCs collected)
- Fertilization rate
- Embryo quality day 3
- Fragmentation rate embryo day 3
- Blastulation rate (Day5/6/7)
- Quality of blastocyst (Gardner criteria) Participants will undergo controlled ovarian stimulation with a GnRH antagonist protocol Researchers will compare the effects of final maturation with GnRH-agonist trigger to a dual trigger (hCG and GnRH-a)
Detailed description
Final oocyte maturation is a critical step in the process of the Assisted Reproductive Technology (ART) treatment and has a certain impact on oocyte yield and oocyte competency. There are three different types of trigger: hCG, GnRH-agonist or dual trigger (hCG and GnRH-agonist combined), and the choice depends on the ovarian stimulation protocol, the ovarian response and on the clinical standard of the IVF clinic. As oocyte donors are at high risk for OHSS, a GnRH-agonist trigger (GnRH-a) is the most commonly used modality for triggering final maturation. However, a certain number of oocyte donors may have a suboptimal response to GnRH-a trigger only, with a yield of oocytes less than the 10th percentile, with a clear negative impact on oocyte efficiency and competency. This study aims to evaluate whether oocyte competence can be improved in oocyte donors with a previously suboptimal response to GnRH-a, by using a dual trigger in a subsequent ovarian stimulation cycle, in which hCG is added to the GnRH-agonist for final maturation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual trigger (GnRH-agonist plus hCG) | Experimental | Drug: Dual trigger (human chorionic gonadotropin plus GnRH-agonist)Participants in this arm will be administered a GnRH-agonist trigger plus hCG (dual trigger) for final maturation |
| Gn-RH-agonist only trigger | Active comparator | Drug: GnRH-agonist only triggerParticipants in this arm will be administered a GnRH-agonist trigger only for final maturation |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- BMI: 18 - 25
- AMH: 1-3ng/ml
- AFC: 15
- Peak E2 in previous ovarian stimulation cycle: < 4000 pg/ml
- Ovarian response in first stimulation cycle: < 20 follicles over 10mm in total, at time of triggering
Key exclusion criteria (1 listed)
- Oocyte donors which are at risk for development of ovarian hyperstimulation syndrome (OHSS)
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 trigger (human chorionic gonadotropin plus GnRH-agonist)Human chorionic gonadotropin will be added to GnRH-agonist as a dual trigger in participants previously having had a suboptimal response to GnRH-agonist trigger only | Drug | Dual trigger (GnRH-agonist plus hCG) |
| GnRH-agonist only triggerGnRH-agonist only will be used for final maturation | Drug | Gn-RH-agonist only trigger |
Primary outcome
Oocyte maturation rate
Time frame: 18 months prospective trial
Number of metaphase II oocytes per total number of oocytes retrieved in oocyte pick-up day
Fertilization rate
Time frame: 18 months prospective trial
number of 2PN embryos per total number of MII oocytes fertilised
Blastulation rate
Time frame: 18 months prospective trial
Number of blastocysts up to day 6 per number of fertilised 2PN embryos
3 secondary outcomes
Number of recipients per donor cycle
Time frame: 18 months prospective trial
Ongoing Pregnancy Rate
Time frame: 28 months prospective trial
Live Birth Rate
Time frame: 28 months prospective trial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: Yes. At the trial completion IPD are to be shared with researchers from ART Fertility Clinics for statistical analysis
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual trigger (human chorionic gonadotropin plus GnRH-agonist) and GnRH-agonist only trigger in people with Ovarian Stimulation and Human Chorionic Gonadotropin, run by Embryolab Fertility Clinic at 1 site in Greece.
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 8 inclusion and 1 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 21 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oocyte maturation rate (time frame: 18 months prospective trial). The study lists 3 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 21 Nov 2023.