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Injection of Day 2 Embryo Culture Supernatant Into the Uterine Cavity Didn't Improve Implantation and Pregnancy Rates

This study has been completed.
Sponsor:
Information provided by:
Shen-Zhen City Maternity and Child Healthcare Hospital
ClinicalTrials.gov Identifier:
NCT00730496
First received: July 31, 2008
Last updated: November 4, 2010
Last verified: August 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Infertility
In Vitro Fertilization
 Procedure: uterine cavity injection of day 2 embryo culture supernatant
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Injection of Day 2 Embryo Culture Supernatant Into the Uterine Cavity Didn't Improve Implantation and Pregnancy Rates of Day 3 Embryo Transfer: a Randomized Clinical Trial in Patients Who Underwent in Vitro Fertilization- Embryo Transfer.

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Shen-Zhen City Maternity and Child Healthcare Hospital:

Primary Outcome Measures:
  • The clinical pregnancy rate and embryo implantation rate. [ Time Frame: two months ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: January 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
the study group, 45 women
 Procedure: uterine cavity injection of day 2 embryo culture supernatant
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.
No Intervention: 2
the control group, 45 women

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   23 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • The women who were treated with natural cycle IVF or had no appropriate embryo for ET were excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00730496

Locations
China, Guang-Dong
Department of Reproductive Centre, Shen-Zhen Maternity and Child Healthcare Hospital
Shenzhen, Guang-Dong, China, 518048
Sponsors and Collaborators
Shen-Zhen City Maternity and Child Healthcare Hospital
Investigators
Study Chair: Wen-Jie Zhu, M.D ShenZhen Maternity and Child Healthcare Hospital
  More Information

No publications provided

Responsible Party: Wen-Jie Zhu, Shen-Zhen City Maternity and Child Healthcare Hospital
ClinicalTrials.gov Identifier: NCT00730496     History of Changes
Other Study ID Numbers: 200803889
Study First Received: July 31, 2008
Last Updated: November 4, 2010
Health Authority: China: Ministry of Health

Keywords provided by Shen-Zhen City Maternity and Child Healthcare Hospital:
Embryo culture supernatant
injection
embryo transfer
embryo implantation rate

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 16, 2013