NCT01139593

Brief Summary

This is a prospective randomized trial comparing the outcome in women undergoing IVF/ICSI when taking their gonadotropin dosage in the morning (am) or evening (pm).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2010

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2010

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 9, 2015

Status Verified

December 1, 2015

Enrollment Period

5.4 years

First QC Date

June 6, 2010

Last Update Submit

December 8, 2015

Conditions

Infertility

Keywords

IVFICSIgonadotropinam dosepm dosepregnancyimplantationlive birth

Outcome Measures

Primary Outcomes (1)

  • Live birth rate

    4 years

Study Arms (2)

morning dose

women undergoing IVF/ICSi taking their gonadotropin dose in the am

evening dose

Women undergoing IVF/ICSI taking their gonadotropin in the evening

Eligibility Criteria

Age21 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Infertile women between 21 and 44 years old

You may qualify if:

  • women between 21-42 undergoing IVF

You may not qualify if:

  • women \> 45,
  • women with one ovary,
  • donor egg,
  • surrogacy,
  • FET cycles,
  • uterine problems,
  • large fibroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Center for Reproductive Medicine

Reston, Virginia, 20190, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

June 6, 2010

First Posted

June 8, 2010

Study Start

June 1, 2010

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

December 9, 2015

Record last verified: 2015-12

Locations

US(1)