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

Phase 1

Completed

• Conditions: Infertility
• Interventions: Procedure: Day 5 embryo transfer group

• Registration Number: NCT01107002
• Lead Sponsor: Royan Institute

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-07
• Status Verified: 2010-04
• Study First Submitted: 2010-04-17
• Study First Submitted QC: 2010-04-19
• Study First Posted: 2010-04-20
• Primary Completion: 2010-05
• Study Completion: 2010-08
• Last Update Submitted: 2011-07-14
• Last Update Posted: 2011-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Day 5 embryo transfer group	Day 5 embryo transfer group	Embryo will transfer at blastocyst stage (day 5 after ovum pick up)

Primary Outcome Measures

Name	Time	Method
Live birth rate	After 37 weeks of gestational age
Clinical Pregnancy rate	6-8 weeks after oocyte retrieval

Secondary Outcome Measures

Name	Time	Method
Implantation rate	4 weeks after embryo transfer
Miscarriage rate	18 weeks after fertilization

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of