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Comparison of 5 Day Embryo Transfer With 2-3 Day Transfer in Patients With Previous In Vitro Fertilization Failure

This study has been completed.
Sponsor:
Information provided by:
Royan Institute
ClinicalTrials.gov Identifier:
NCT01107002
First received: April 17, 2010
Last updated: July 14, 2011
Last verified: April 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Infertility
 Procedure: Day 5 embryo transfer group
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of 5 Day Embryo Transfer With 2-3 Day Transfer in Patients Who Failed to Conceive in Two or More Day 2-3 Embryo Transfer Cycle in Royan Institute

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • Clinical Pregnancy rate [ Time Frame: 6-8 weeks after oocyte retrieval ] [ Designated as safety issue: Yes ]
  • Live birth rate [ Time Frame: After 37 weeks of gestational age ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Implantation rate [ Time Frame: 4 weeks after embryo transfer ] [ Designated as safety issue: No ]
  • Miscarriage rate [ Time Frame: 18 weeks after fertilization ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: July 2008
Study Completion Date: August 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Day 5 embryo transfer group
Embryo will transfer at blastocyst stage (day 5 after ovum pick up)
 Procedure: Day 5 embryo transfer group
Embryo will transfer at blastocyst stage (day 5 after ovum pick up)

Detailed Description:

A total of 200 infertile women with at least two previous IVF failures will enroll in this prospective randomized clinical trial study and will randomly be divided into two groups. Random permuted blocks with a block size of 4 will be used to ensure randomization and complete allocation concealment.

The study protocol will be assessed by an independent institutional review board and Royan ethics committee.

Ovarian stimulation protocol will include the use of a GnRH agonist (Superfact; Aventis Pharma Deutshlan, Frankfurt, Germany) administered in the long (down-regulation) protocol and the subsequent addition of FSH (Gonal F, Sereno, Switzerland). Embryos will be initially cultured in G1.V5 medium) Vitrolife-Sweden)TM on day 1 and 2, being transferred from this medium to G2.V5 ) Vitrolife-Sweden)TM on day 3. Embryos will be transferred on day 5, depending on the degree of expansion of the blastocyst.

Main outcome measures will be implantation, clinical pregnancy and live birth rates.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Women with submucous myoma
  • Women with intra mural or subserous myoma greater than 3 cm
  • Women with Endometriosis or Endometrioma
  • Hydrosalpinx
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107002

Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of, 19395-4644
Sponsors and Collaborators
Royan Institute
Investigators
Principal Investigator: Mahnaz Ashrafi,, MD Royan Institute
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Hamid Gourabi, Chief, Royan Institute
ClinicalTrials.gov Identifier: NCT01107002     History of Changes
Other Study ID Numbers: Royan-Emb-006
Study First Received: April 17, 2010
Last Updated: July 14, 2011
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
infertility
Embryo transfer

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

ClinicalTrials.gov processed this record on May 19, 2013