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

Royan Institute

Status and phase: Completed; Phase 2; Phase 1

Conditions: Infertility

Treatments: Procedure: Day 5 embryo transfer group

Study type: Interventional

Funder types: Other

Identifiers

NCT01107002

Royan-Emb-006

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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200 participants in 1 patient group

Day 5 embryo transfer group

Experimental group

Description:

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

Treatment:

Procedure: Day 5 embryo transfer group