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

Study Overview
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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

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.

Official Title
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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

Conditions
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Infertility

Intervention / Treatment
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* Procedure: Day 5 embryo transfer group


Participation Criteria
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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 Exclusion Criteria: Women with submucous myoma Women with intra mural or subserous myoma greater than 3 cm Women with Endometriosis or Endometrioma Hydrosalpinx

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Day 5 embryo transfer group<br>Embryo will transfer at blastocyst stage (day 5 after ovum pick up) | Procedure: Day 5 embryo transfer group<br>* Embryo will transfer at blastocyst stage (day 5 after ovum pick up)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Pregnancy rate |  | 6-8 weeks after oocyte retrieval | 
| Live birth rate |  | After 37 weeks of gestational age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate |  | 4 weeks after embryo transfer | 
| Miscarriage rate |  | 18 weeks after fertilization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infertility, Embryo transfer