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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:
ClinicalTrials.gov Identifier:
NCT01107002
First Posted: April 20, 2010
Last Update Posted: July 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Royan Institute
  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
Intervention Model: Single Group Assignment
Masking: Single (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:


Further study details as provided by Royan Institute:

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

Secondary Outcome Measures:
  • Implantation rate [ Time Frame: 4 weeks after embryo transfer ]
  • Miscarriage rate [ Time Frame: 18 weeks after fertilization ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Hamid Gourabi, Chief, Royan Institute
ClinicalTrials.gov Identifier: NCT01107002     History of Changes
Other Study ID Numbers: Royan-Emb-006
First Submitted: April 17, 2010
First Posted: April 20, 2010
Last Update Posted: July 15, 2011
Last Verified: April 2010

Keywords provided by Royan Institute:
infertility
Embryo transfer

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


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