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

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").

Study Overview

• Status: Recruiting
• Conditions: Infertility, Female
• Intervention / Treatment: Procedure: Ovulatory trigger timing

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Forest Garner, MS; Phone Number: 264 7022541777; Email: Forest@fertilitycenterlv.com

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89117
      • Recruiting
      • Fertility center of Las Vegas
      • Contact: Shironda Anderson, BA; Phone Number: 265 702-254-1777; Email: Shironda@fertilitycenterlv.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 34 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. 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.
2. 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.
3. Ability read and understand English sufficiently to obtain informed consent.
4. Patients with prior IVF cycles are allowed, but no patient can undergo more than one cycle with oocyte collection under this study.

Exclusion Criteria:

1. Any cycle type that would preclude immediate culture to blastocyst stage (e.g. oocyte banking).
2. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Trigger	Procedure: Ovulatory trigger timing; Timing of medication to induce final oocyte maturation
Experimental: Delayed trigger	Procedure: Ovulatory trigger timing; Timing of medication to induce final oocyte maturation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fertility Center of Las Vegas

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2022
• Primary Completion (Anticipated): August 31, 2024
• Study Completion (Anticipated): November 30, 2025

Study Registration Dates

• First Submitted: August 10, 2022
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (Actual): August 12, 2022

Study Record Updates

• Last Update Posted (Actual): August 12, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: FCLV-2022-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No