Back to resultsThe Impact of the Timing of Trigger on IVF Success
Primary Purpose
Fertilization in Vitro, Infertility, Embryonic Development
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Timing of trigger
Sponsored by
About this trial
This is an interventional treatment trial for Fertilization in Vitro
Eligibility Criteria
Inclusion Criteria:
- Planning to move forward with an IVF cycle
- Have met the requirements of being a patient at CCRM Colorado
- AMA: 39-44 years old And/or
- DOR: AMH < 1 & FSH >10 (age independent)
Exclusion Criteria:
- Contraindication for pregnancy
- Have not fulfilled requirements for IVF cycle
- Single gene couple or chromosomal rearrangement
- Severe male factor or testicular surgical sperm removal (need sufficient sperm for ICSI)
- One ovary
- Uterine anomalies
- Stage III or IV endometriosis
- Explained recurrent miscarriage
- PCO or PCOS
- Using donor oocyte or gestational carrier
Sites / Locations
- Colorado Center for Reproductive Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Testing group
Control group
Arm Description
Timing of trigger at end of ovarian stimulation in an IVF cycle: trigger when 2 follicles reach 18mm, OR 1 follicle reaches 18mm AND 1 follicle is between 16-18mm.
Outcomes
Primary Outcome Measures
Euploid Embryos: the percentage of euploid embryos produced as analyzed by comprehensive chromosomal screening, of total embryos tested
Secondary Outcome Measures
Egg maturation: the proportion of mature eggs of total number of eggs retrieved
Live birth outcomes: the incidence of pregnancy resulting in live birth following embryo transfer of embryos produced by this IVF cycle
Full Information
NCT ID
NCT02990949
First Posted
December 6, 2016
Last Updated
October 12, 2022
Sponsor
Colorado Center for Reproductive Medicine
Collaborators
Fertility Laboratories Of Colorado
1. Study Identification
Unique Protocol Identification Number
NCT02990949
Brief Title
The Impact of the Timing of Trigger on IVF Success
Official Title
The Impact of the Timing of Trigger on IVF Success: Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Stopped due to lack of enrollement
Study Start Date
November 2016 (Actual)
Primary Completion Date
May 9, 2022 (Actual)
Study Completion Date
June 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colorado Center for Reproductive Medicine
Collaborators
Fertility Laboratories Of Colorado
4. Oversight
5. Study Description
Brief Summary
The aim of this study is to examine the length of ovarian stimulation with the timing of trigger in an IVF cycle and its potential to impact patient outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fertilization in Vitro, Infertility, Embryonic Development
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Testing group
Arm Type
Experimental
Arm Description
Timing of trigger at end of ovarian stimulation in an IVF cycle: trigger when 2 follicles reach 18mm, OR 1 follicle reaches 18mm AND 1 follicle is between 16-18mm.
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Timing of trigger
Primary Outcome Measure Information:
Title
Euploid Embryos: the percentage of euploid embryos produced as analyzed by comprehensive chromosomal screening, of total embryos tested
Time Frame
4 weeks after egg retrieval
Secondary Outcome Measure Information:
Title
Egg maturation: the proportion of mature eggs of total number of eggs retrieved
Time Frame
1 week after egg retrieval
Title
Live birth outcomes: the incidence of pregnancy resulting in live birth following embryo transfer of embryos produced by this IVF cycle
Time Frame
9 months after frozen embryo transfer
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
26 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Planning to move forward with an IVF cycle
Have met the requirements of being a patient at CCRM Colorado
AMA: 39-44 years old And/or
DOR: AMH < 1 & FSH >10 (age independent)
Exclusion Criteria:
Contraindication for pregnancy
Have not fulfilled requirements for IVF cycle
Single gene couple or chromosomal rearrangement
Severe male factor or testicular surgical sperm removal (need sufficient sperm for ICSI)
One ovary
Uterine anomalies
Stage III or IV endometriosis
Explained recurrent miscarriage
PCO or PCOS
Using donor oocyte or gestational carrier
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mandy Katz-Jaffe, PhD
Organizational Affiliation
CCRM, FLC
Official's Role
Study Director
Facility Information:
Facility Name
Colorado Center for Reproductive Medicine
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Impact of the Timing of Trigger on IVF Success
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