150 Participants Needed

Trigger Timing in Controlled Ovarian Stimulation for Female Infertility

FG
Overseen ByForest Garner, MS
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Fertility Center of Las Vegas
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This randomized trial will compare the efficacy of two different times of administration of medications for final oocyte maturation, commonly called a "trigger", in cycles of controlled ovarian stimulation (COS) for cycles in which all embryos will be cryopreserved ("freeze-all cycles").

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is the timing of ovulation triggers in controlled ovarian stimulation safe for humans?

The use of human chorionic gonadotropin (hCG) for triggering ovulation can lead to ovarian hyperstimulation syndrome (OHSS), a potential risk. However, using a gonadotropin-releasing hormone agonist (GnRH-a) instead of hCG can reduce this risk, making it a safer option for ovulation triggering.12345

How is the ovulatory trigger timing treatment different from other treatments for female infertility?

The ovulatory trigger timing treatment using hCG (human chorionic gonadotropin) is unique because it mimics the natural LH (luteinizing hormone) surge to induce ovulation, but it may not optimally support the early luteal phase compared to natural cycles. This treatment is different from others as it can lead to faster and higher hormone levels than naturally observed, potentially affecting implantation success.678910

What data supports the effectiveness of the treatment for ovulatory trigger timing in controlled ovarian stimulation for female infertility?

Research suggests that using a combination of triggers, like hCG and GnRH agonist, can improve the number and quality of mature eggs and embryos in women undergoing fertility treatments. This approach, known as a 'dual trigger', has shown promise in improving pregnancy outcomes, especially in women who have a high rate of immature eggs.3671112

Are You a Good Fit for This Trial?

This trial is for adult women aged 18-35 with normal ovarian response, who are undergoing IVF and plan to freeze all embryos reaching the blastocyst stage. They must understand English to consent and can have had previous IVF cycles but only one cycle under this study.

Inclusion Criteria

I have had IVF before, but I haven't collected eggs more than once in this study.
Ability to read and understand English sufficiently to obtain informed consent
My tests show I have a normal or better chance of producing eggs.
See 1 more

Exclusion Criteria

Any cycle type that would preclude immediate culture to blastocyst stage (e.g. oocyte banking)
Any condition that, in the opinion of the physician or principal investigator, would place the patient at undue risk under this protocol or would otherwise make the protocol inappropriate for that subject

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo controlled ovarian stimulation with early or delayed trigger timing for final oocyte maturation

Varies based on follicle development

Follow-up

Participants are monitored for the formation of good-quality blastocysts within 7 days of oocyte retrieval

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Ovulatory trigger timing
Trial Overview The study tests two different timings for administering 'trigger' drugs that help mature eggs in controlled ovarian stimulation during IVF. All participants will have their embryos frozen at the blastocyst stage for future use.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Early TriggerExperimental Treatment1 Intervention
Group II: Delayed triggerExperimental Treatment1 Intervention

Ovulatory trigger timing is already approved in European Union, United States, Canada for the following indications:

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Approved in European Union as hCG trigger for:
  • Assisted reproductive technology (ART)
  • Infertility treatment
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Approved in United States as hCG trigger for:
  • Infertility treatment
  • Ovulation induction
  • Assisted reproductive technology (ART)
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Approved in Canada as hCG trigger for:
  • Infertility treatment
  • Assisted reproductive technology (ART)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fertility Center of Las Vegas

Lead Sponsor

Trials
6
Recruited
550+

Published Research Related to This Trial

In a review of 365 controlled ovarian hyperstimulation (COH) cycles, the overall clinical pregnancy rate was 18.1%, with r-hCG administration before intrauterine insemination (IUI) leading to a significantly higher pregnancy rate (18.2%) compared to spontaneous LH surge (5.8%).
When r-hCG was given alongside a serum LH surge, the clinical pregnancy rate increased even further to 30.8%, especially in patients treated with r-FSH, highlighting the importance of timing and medication in improving fertility outcomes.
Controlled Ovarian Hyperstimulation with Intrauterine Insemination Is More Successful After r-hCG Administration Than Spontaneous LH Surge.Taerk, E., Hughes, E., Greenberg, C., et al.[2020]
In a study of 73 women under 40 with low oocyte maturation rates, the dual trigger method (using both GnRH agonist and hCG) significantly improved oocyte maturation rates (84.0% vs. 55.5%) compared to the traditional hCG trigger.
The dual trigger also led to higher cumulative pregnancy rates (69.4% vs. 40.0%) and live birth rates (66.7% vs. 36.0%), suggesting it may be a more effective option for enhancing reproductive outcomes in this population.
Dual trigger for final oocyte maturation in expected normal responders with a high immature oocyte rate: a randomized controlled trial.Yan, MH., Sun, ZG., Song, JY.[2023]
In a study of 140 IVF patients with premature LH surge, earlier oocyte retrieval (OPU) did not significantly reduce the risk of cycle cancellation compared to standard timing, with cancellation rates of 74.3% for earlier OPU versus 65.9% for standard timing.
Despite a higher clinical pregnancy rate (44.4%) in the earlier OPU group compared to standard timing (27.3%), this group also experienced a significantly higher miscarriage rate (22% vs. 0%), indicating potential risks associated with earlier retrieval.
The effectiveness of earlier oocyte retrieval in the case of a premature luteinizing hormone surge on hCG day in in vitro fertilization-embryo transfer cycles.Choi, MH., Cha, SH., Park, CW., et al.[2021]

Citations

Controlled Ovarian Hyperstimulation with Intrauterine Insemination Is More Successful After r-hCG Administration Than Spontaneous LH Surge. [2020]
Dual trigger for final oocyte maturation in expected normal responders with a high immature oocyte rate: a randomized controlled trial. [2023]
The effectiveness of earlier oocyte retrieval in the case of a premature luteinizing hormone surge on hCG day in in vitro fertilization-embryo transfer cycles. [2021]
GnRH Agonist and hCG (Dual Trigger) Versus hCG Trigger for Final Oocyte Maturation in Expected Normal Responders With a High Immature Oocyte Rate: Study Protocol for a Randomized, Superiority, Parallel Group, Controlled Trial. [2022]
Does double trigger (GnRH-agonist + hCG) improve outcome in poor responders undergoing IVF-ET cycle? A pilot study. [2019]
[Therapeutic induction of ovulation: towards the replacement of hCG with LH]. [2006]
Triggering final follicular maturation--hCG, GnRH-agonist or both, when and to whom? [2018]
The dual trigger study: Rationale and study design of a prospective double-blind randomized clinical trial comparing pregnancy rates after co-administration of low dose hCG at the time of GnRH agonist trigger or 35 h later for the prevention of OHSS. [2020]
Timing of oocyte retrieval in cycles with a spontaneous luteinizing hormone surge in a large in vitro fertilization program. [2019]
Follicular aspiration versus coasting for ovarian hyper-stimulation syndrome prevention. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Elevated luteinizing hormone on the day of human chorionic gonadotropin administration does not reduce cycle fecundity in a low-dose flare-up in vitro fertilization protocol. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Shortcomings of an unphysiological triggering of oocyte maturation using human chorionic gonadotropin. [2021]
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