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

Not Applicable

Recruiting

• Conditions: Infertility, Female
• Interventions: Procedure: Ovulatory trigger timing

• Registration Number: NCT05498350
• Lead Sponsor: Fertility Center of Las Vegas

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.

Study Timeline

• Status Verified: 2022-08
• Study Start: 2022-08-10
• Study First Submitted: 2022-08-10
• Study First Submitted QC: 2022-08-10
• Last Update Submitted: 2022-08-10
• Study First Posted: 2022-08-12
• Last Update Posted: 2022-08-12
• Primary Completion: 2024-08-31
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Trigger	Ovulatory trigger timing	-
Delayed trigger	Ovulatory trigger timing	-

Primary Outcome Measures

Name	Time	Method
Delayed blastocyst formation	Within 7 days of oocyte retrieval	Proportion of good-quality of blastocysts that formed after day 5.
Good-quality blastocysts	Within 7 days of oocyte retrieval	Number of blastocysts with A or B morphological grade.

Trial Locations

Locations (1)

Fertility center of Las Vegas; 🇺🇸 Las Vegas, Nevada, United States