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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05498350
• Other study ID #: FCLV-2022-1
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2022
• Est. completion date: November 30, 2025

Study information

• Verified date: August 2022
• Source: Fertility Center of Las Vegas
• Contact: Forest Garner, MS
• Phone: 7022541777
• Email: Forest[@]fertilitycenterlv.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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").

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 30, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Procedure:
• Ovulatory trigger timing
Timing of medication to induce final oocyte maturation

Locations

Country	Name	City	State
United States	Fertility center of Las Vegas	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Fertility Center of Las Vegas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Good-quality blastocysts	Number of blastocysts with A or B morphological grade.	Within 7 days of oocyte retrieval
Primary	Delayed blastocyst formation	Proportion of good-quality of blastocysts that formed after day 5.	Within 7 days of oocyte retrieval