The Clinical Outcomes Following Transfer of Blastocysts Cultured From Thawed Cleavage Stage Embryos

R

Royan Institute

Status and phase

Completed
Phase 3

Conditions

Infertility

Treatments

Procedure: Embryo Transferring
Procedure: Blastocyte Transferring

Study type

Interventional

Funder types

Other

Identifiers

NCT02681029
Royan-Emb-023

Details and patient eligibility

About

Recent improvements in cell culture systems have led to a shift in in vitro fertilization (IVF) practice from early cleavage stage embryo transfer (ET) to blastocyst transfer. Blastocyst culture and transfer could theoretically provide better synchronization between the embryo and the uterine endometrium. The purpose of this study is comparing pregnancy rates and implantation rate following transfer of thawed cleavage embryos and blastocysts cultured from thawed cleavage embryos.

Full description

The proposal of this study approved by our institutional review boards and institution's ethical committee, and all participants will sign a written consent before enter to study. All patients will be randomly divided into two groups of thawed cleavage embryo transfers and transfers of blastocysts from thawed cleavage embryos. Embryos will be transferred in hormone replacement cycles. Preparation of the endometrium will be started in the second day of menstruation and will be continued according to their transfer type (blastocyst or cleavage). βhCG will be assessed 14 days after embryo transfer. Treatment cycle outcomes will be compared between 2 groups.

Enrollment

220 patients

Sex

Female

Ages

16 to 37 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • The patients with first type of infertility
  • Age ≤ 37 years
  • Long ovulation induction protocol

Exclusion criteria

  • Any previous surgery on the uterus and ovaries
  • Uterine factor infertility
  • Sever Male factor infertility (TESE, TESA ،Oligoteratozoospermia)
  • Recurrent abortion
  • The women with poor ovarian reserve

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

220 participants in 2 patient groups, including a placebo group

Blastocyst transplantation
Experimental group
Description:
The infertile women who underwent intra- uterus transferring of blastocyst from thawed cleavage embryo
Treatment:
Procedure: Blastocyte Transferring
Control
Placebo Comparator group
Description:
The infertile women who underwent intra- uterus transferring of thawed cleavage embryo.
Treatment:
Procedure: Embryo Transferring

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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