NCT01107002

Brief Summary

The purpose of this study is to determine whether embryo transfer on day 3 versus day 5 shows a significant difference in implantation, clinical pregnancy, live birth, miscarriage and multiple pregnancy rates among women with at least two previous IVF failures

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2008

Typical duration for phase_1

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

July 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 20, 2010

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

July 15, 2011

Status Verified

April 1, 2010

Enrollment Period

1.8 years

First QC Date

April 17, 2010

Last Update Submit

July 14, 2011

Conditions

Infertility

Keywords

infertilityEmbryo transfer

Outcome Measures

Primary Outcomes (2)

  • Clinical Pregnancy rate

    6-8 weeks after oocyte retrieval

  • Live birth rate

    After 37 weeks of gestational age

Secondary Outcomes (2)

  • Implantation rate

    4 weeks after embryo transfer

  • Miscarriage rate

    18 weeks after fertilization

Study Arms (1)

Day 5 embryo transfer group

EXPERIMENTAL

Embryo will transfer at blastocyst stage (day 5 after ovum pick up)

Procedure: Day 5 embryo transfer group

Interventions

Day 5 embryo transfer groupPROCEDURE

Embryo will transfer at blastocyst stage (day 5 after ovum pick up)

Day 5 embryo transfer group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age fewer than 40
  • Normal uterine cavity and patent tubes by either hysterosalpingogram or laparoscopy and hysteroscopy
  • Two previous or more failed IVF/ICSI cycles

You may not qualify if:

  • Women with submucous myoma
  • Women with intra mural or subserous myoma greater than 3 cm
  • Women with Endometriosis or Endometrioma
  • Hydrosalpinx

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royan Institute

Tehran, 19395-4644, Iran

Location

Related Links

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Mahnaz Ashrafi,, MD

    Royan Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

April 17, 2010

First Posted

April 20, 2010

Study Start

July 1, 2008

Primary Completion

May 1, 2010

Study Completion

August 1, 2010

Last Updated

July 15, 2011

Record last verified: 2010-04

Locations

IR(1)