Randomized Trial Comparing Early "Trigger" Versus Delayed "Trigger" Timing in Cycles of Controlled Ovarian Stimulation.
1 other identifier
interventional
150
1 country
1
Brief Summary
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").
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2022
CompletedStudy Start
First participant enrolled
August 10, 2022
CompletedFirst Posted
Study publicly available on registry
August 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2025
CompletedAugust 12, 2022
August 1, 2022
2.1 years
August 10, 2022
August 10, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Good-quality blastocysts
Number of blastocysts with A or B morphological grade.
Within 7 days of oocyte retrieval
Delayed blastocyst formation
Proportion of good-quality of blastocysts that formed after day 5.
Within 7 days of oocyte retrieval
Study Arms (2)
Early Trigger
EXPERIMENTALDelayed trigger
EXPERIMENTALInterventions
Timing of medication to induce final oocyte maturation
Eligibility Criteria
You may qualify if:
- Adult female at least 18 years of age and less than 35 years of age intending to undergo ovarian stimulation for a cycle of IVF with all embryos to be frozen that attain the blastocyst stage.
- Anticipated at least normal ovarian response evidenced by at least 8 antral follicles observed on ultrasound or a serum level of at least 1.5 ng/ml AMH.
- Ability read and understand English sufficiently to obtain informed consent.
- Patients with prior IVF cycles are allowed, but no patient can undergo more than one cycle with oocyte collection under this study.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fertility center of Las Vegas
Las Vegas, Nevada, 89117, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director
Study Record Dates
First Submitted
August 10, 2022
First Posted
August 12, 2022
Study Start
August 10, 2022
Primary Completion
August 31, 2024
Study Completion
November 30, 2025
Last Updated
August 12, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share