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Ovulation Trigger Strategies in Low Ovarian Reserve (TRIGGERBEST)
Plain-language guide to NCT07816562: phase 3 randomized trial of hCG (human chorionic gonadotropin) and Triptorelin, 126 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07816562
- Phase
- phase 3
- Status
- recruiting participants
- Start
- 2024-09-17
- Completion (planned or actual)
- 2027-07-01
- Participants
- 126 (estimated)
- Design
- randomized, single-blind, treatment
- Conditions studied
- Low Ovarian Reserve; Poor Ovarian Response
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test hCG (human chorionic gonadotropin) and Triptorelin.
This study aims to compare different ovulation triggering strategies in women with low ovarian reserve undergoing fresh in vitro fertilization (IVF) cycles.
Ovulation triggering is a key step in IVF treatment, as it determines final oocyte maturation prior to oocyte retrieval.
Participants are randomly assigned to one of three ovulation trigger approaches: human chorionic gonadotropin (hCG) alone, follitropin delta combined with hCG, or dual trigger using a gonadotropin-releasing hormone (GnRH) agonist plus hCG.
It had three arms (groups): hCG alone (experimental), Follitropin delta + hCG (experimental) and Dual trigger (experimental).
Ovulation triggering using human chorionic gonadotropin (hCG) alone.
Ovulation triggering using follitropin delta in combination with human chorionic gonadotropin (hCG).
Ovulation triggering using a gonadotropin-releasing hormone (GnRH) agonist in combination with human chorionic gonadotropin (hCG).
The registry classes the interventions as drug.
More on the Plan
Final oocyte maturation is a critical step in assisted reproductive techniques (ART) and is largely determined by the ovulation triggering strategy.
In women with low ovarian reserve, achieving an adequate number of mature oocytes remains a major challenge, even when established trigger protocols are used.
However, despite this approach, oocyte yield and maturity often remain suboptimal.
The addition of exogenous follicle-stimulating hormone (FSH) activity at the time of ovulation triggering has been proposed as a potential strategy to further optimize final oocyte maturation.
Who Took Part
The registry lists 126 planned participants were the target.
It was open to women only aged from 18 years up to 42 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Signed informed consent. Women aged between 18 and 42 years. Women with low ovarian response classified within one of the groups defined by the POSEIDON criteria.
The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: more than two previous failed ovarian stimulation cycles; female age \>42 years; body mass index (bmi) \>35 kg/m².
How the Study Was Run
The set-up was randomized, parallel-group and single-blind.
Because people in this hCG (human chorionic gonadotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The hCG (human chorionic gonadotropin) group and the comparison group ran side by side rather than switching.
Only one side, usually the participants, was kept unaware of whether hCG (human chorionic gonadotropin) was given.
Those kept unaware of assignments: investigator.
It started in 2024-09-17 with completion listed for 2027-07-01.
It ran at 1 site in Spain.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Number of mature oocytes (MII) (time frame: During the oocyte retrieval procedure).
It also tracked 3 secondary outcomes, for example Proportion of mature oocytes, Biochemical pregnancy rate per embryo transfer and Ongoing pregnancy rate.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of hCG (human chorionic gonadotropin) and Triptorelin in 126 people.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the hCG (human chorionic gonadotropin) compound page and the Triptorelin compound page, all human trials.
Our Notes on the Compounds
hCG (human chorionic gonadotropin): An LH analog that drives Leydig-cell testosterone production.
Triptorelin: A 10-amino-acid GnRH analog (Trelstar, Decapeptyl, Triptodur) used in prostate cancer, early puberty and fertility protocols.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.