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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-08-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Day 5 embryo transfer group

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

Group Type EXPERIMENTAL

Day 5 embryo transfer group

Intervention Type PROCEDURE

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

Interventions

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Day 5 embryo transfer group

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

Intervention Type PROCEDURE

Eligibility Criteria

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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