NCT02990949

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 6, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

October 14, 2022

Status Verified

October 1, 2022

Enrollment Period

5.5 years

First QC Date

December 6, 2016

Last Update Submit

October 12, 2022

Conditions

Fertilization in VitroInfertilityEmbryonic Development

Outcome Measures

Primary Outcomes (1)

  • Euploid Embryos: the percentage of euploid embryos produced as analyzed by comprehensive chromosomal screening, of total embryos tested

    4 weeks after egg retrieval

Secondary Outcomes (2)

  • Egg maturation: the proportion of mature eggs of total number of eggs retrieved

    1 week after egg retrieval

  • Live birth outcomes: the incidence of pregnancy resulting in live birth following embryo transfer of embryos produced by this IVF cycle

    9 months after frozen embryo transfer

Study Arms (2)

Testing group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Interventions

Timing of triggerOTHER
Testing group

Eligibility Criteria

Age26 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colorado Center for Reproductive Medicine

Lone Tree, Colorado, 80124, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Mandy Katz-Jaffe, PhD

    CCRM, FLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2016

First Posted

December 13, 2016

Study Start

November 1, 2016

Primary Completion

May 9, 2022

Study Completion

June 15, 2022

Last Updated

October 14, 2022

Record last verified: 2022-10

Locations

US(1)