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Clinical Trials/NCT05498350
NCT05498350
Recruiting
Not Applicable

Randomized Trial Comparing Early "Trigger" Versus Delayed "Trigger" Timing in Cycles of Controlled Ovarian Stimulation.

Fertility Center of Las Vegas1 site in 1 country150 target enrollmentAugust 10, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infertility, Female
Sponsor
Fertility Center of Las Vegas
Enrollment
150
Locations
1
Primary Endpoint
Delayed blastocyst formation
Status
Recruiting
Last Updated
3 years ago

Overview

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").

Detailed Description

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"). 1. The early trigger timing will be based on sonographic observation of at least three follicles reaching at least 17mm in diameter. 2. The delayed trigger timing will be based on at least three follicles reaching at least 22mm in diameter.

Registry
clinicaltrials.gov
Start Date
August 10, 2022
End Date
November 30, 2025
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Fertility Center of Las Vegas
Responsible Party
Principal Investigator
Principal Investigator

Bruce Shapiro M.D.

Medical Director

Fertility Center of Las Vegas

Eligibility Criteria

Inclusion Criteria

  • 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.

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.

Outcomes

Primary Outcomes

Delayed blastocyst formation

Time Frame: Within 7 days of oocyte retrieval

Proportion of good-quality of blastocysts that formed after day 5.

Good-quality blastocysts

Time Frame: Within 7 days of oocyte retrieval

Number of blastocysts with A or B morphological grade.

Study Sites (1)

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