NCT00730496

Brief Summary

Forty-five infertile women undergoing in vitro fertilization treatment were managed by uterine cavity injection of day 2 embryo culture supernatant before day 3 embryo transfer. No statistically significant differences were found in implantation and pregnancy rates when compared with control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2008

Shorter than P25 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

January 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 8, 2008

Completed
Last Updated

November 5, 2010

Status Verified

August 1, 2008

Enrollment Period

6 months

First QC Date

July 31, 2008

Last Update Submit

November 4, 2010

Conditions

InfertilityIn Vitro Fertilization

Keywords

Embryo culture supernatantinjectionembryo transferembryo implantation rate

Outcome Measures

Primary Outcomes (1)

  • The clinical pregnancy rate and embryo implantation rate.

    two months

Study Arms (2)

1

EXPERIMENTAL

the study group, 45 women

Procedure: uterine cavity injection of day 2 embryo culture supernatant

2

NO INTERVENTION

the control group, 45 women

Interventions

uterine cavity injection of day 2 embryo culture supernatantPROCEDURE

On the day 2, the embryos were translated from the old dish to a new dish with fresh media and cultured continuously. In study group, the embryo culture supernatant at the old dish were aspirated by using embryo transfer catheter (COOK-5000, Australia) and injected into the patient's uterine cavity. But in the control group, this intervention was not done. Conventional ET was performed on the third day of embryo culture for both groups.

1

Eligibility Criteria

Age23 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The participants were only those women who were first going to undergo IVF or ICSI treatment.

You may not qualify if:

  • The women who were treated with natural cycle IVF or had no appropriate embryo for ET were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Reproductive Centre, Shen-Zhen Maternity and Child Healthcare Hospital

Shenzhen, Guangdong, 518048, China

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Wen-Jie Zhu, M.D

    Shenzhen Maternity and Child Healthcare Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 31, 2008

First Posted

August 8, 2008

Study Start

January 1, 2008

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

November 5, 2010

Record last verified: 2008-08

Locations

CN(1)