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OpenTrials
Completed

NCT Number: NCT01107002

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

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

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Royan Institute

Tehran, 19395-4644, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Day 5 embryo transfer group

Procedure

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

Primary outcomes

  1. Clinical Pregnancy rate

    Time frame: 6-8 weeks after oocyte retrieval

  2. Live birth rate

    Time frame: After 37 weeks of gestational age

Secondary outcomes

  1. Implantation rate

    Time frame: 4 weeks after embryo transfer

  2. Miscarriage rate

    Time frame: 18 weeks after fertilization

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 20, 2010
Registry last updated
Jul 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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