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The Impact of the Timing of Trigger on IVF Success

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02990949
Recruitment Status : Recruiting
First Posted : December 13, 2016
Last Update Posted : June 26, 2020
Sponsor:
Collaborator:
Fertility Laboratories Of Colorado
Information provided by (Responsible Party):
Colorado Center for Reproductive Medicine

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.

Condition or disease Intervention/treatment Phase
Fertilization in Vitro Infertility Embryonic Development Other: Timing of trigger Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of the Timing of Trigger on IVF Success: Randomized Control Trial
Study Start Date : November 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

Arm Intervention/treatment
Experimental: Testing group
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.
Other: Timing of trigger
No Intervention: Control group



Primary Outcome Measures :
  1. 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 Measures :
  1. Egg maturation: the proportion of mature eggs of total number of eggs retrieved [ Time Frame: 1 week after egg retrieval ]
  2. 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 ]


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Ages Eligible for Study:   26 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990949


Contacts
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Contact: Mandy Katz-Jaffe, PhD TriggerStudy@colocrm.com
Contact: Rachel Makloski, RN 303-788-8300 TriggerStudy@colocrm.com

Locations
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United States, Colorado
Colorado Center for Reproductive Medicine Recruiting
Lone Tree, Colorado, United States, 80124
Contact: Rachel Makloski, RN       TriggerStudy@colocrm.com   
Sponsors and Collaborators
Colorado Center for Reproductive Medicine
Fertility Laboratories Of Colorado
Investigators
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Study Director: Mandy Katz-Jaffe, PhD CCRM, FLC
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Responsible Party: Colorado Center for Reproductive Medicine
ClinicalTrials.gov Identifier: NCT02990949    
Other Study ID Numbers: 20160397
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Additional relevant MeSH terms:
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Infertility