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

NCT ID: NCT05498350

Last Updated: 2022-08-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-10
• Study Completion Date: 2025-11-30

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.

Conditions

Infertility, Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early Trigger

Group Type: EXPERIMENTAL

Ovulatory trigger timing

Intervention Type: PROCEDURE

Timing of medication to induce final oocyte maturation

Delayed trigger

Group Type: EXPERIMENTAL

Ovulatory trigger timing

Intervention Type: PROCEDURE

Timing of medication to induce final oocyte maturation

Interventions

Ovulatory trigger timing

Timing of medication to induce final oocyte maturation

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 34 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fertility Center of Las Vegas

INDUSTRY

Sponsor Role: lead

Responsible Party

Bruce Shapiro M.D.

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fertility center of Las Vegas

Las Vegas, Nevada, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Forest Garner, MS

Role: CONTACT

Forest@fertilitycenterlv.com

7022541777 ext. 264

Facility Contacts

Shironda Anderson, BA

Role: primary

Shironda@fertilitycenterlv.com

702-254-1777 ext. 265

Other Identifiers

FCLV-2022-1

Identifier Type: -

Identifier Source: org_study_id