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CompletedNCT02681029Updated May 12, 2021

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

A Phase 3 interventional study of Blastocyte Transferring and Embryo Transferring in Infertility, sponsored by Royan Institute. Completed at 1 site in Iran, Islamic Republic of. Open to female participants aged 16 Years to 37 Years. Per ClinicalTrials.gov, last updated 2021-05-12.

Sponsored by Royan Institute · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
16 Years to 37 Years
Sex
Female
01

Study summary

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.

Read the detailed 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.

02

Conditions studied

  • Infertility

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Keywords

  • Cleavage stage blastocyst transfer cryopreservation
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 220 is above the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Royan Institute is the lead sponsor of 92 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 37 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
220 participants (actual)

Study arms

  • Experimental
    Blastocyst transplantation

    The infertile women who underwent intra- uterus transferring of blastocyst from thawed cleavage embryo

    Procedure: Blastocyte Transferring

  • Placebo comparator
    Control

    The infertile women who underwent intra- uterus transferring of thawed cleavage embryo.

    Procedure: Embryo Transferring

Interventions

  • ProcedureBlastocyte Transferring

    Intra-uterine transferring of blastocyst from thawed cleavage embryo in infertile women.

  • ProcedureEmbryo Transferring

    Inta-uterine transferring of thawed cleavage embryo transfer in infertile women.

06

What researchers measure

Primary outcomes

  1. Pregnancy Rate

    Evaluation of pregnancy rate in women 4 weeks after embryos transfer (ET).

    Time frame: 4weeks

Secondary outcomes

  1. Miscarriage Rate

    Evaluation the miscarriage rate in women 14 days after embryo transfer (ET) with BHCG titration.

    Time frame: 14 days

  2. Implantation Rate

    Evaluation the implantation rate in women 14 days after embryo transfer (ET) with BHCG titration..

    Time frame: 14 days

  3. Ongoing pregnancy rate

    Evaluation the ongoing pregnancy rate in women 14 days after embryo transfer (ET) with BHCG titration..

    Time frame: 14 days

07

Study locations

1 site
  • Royan Institute
    Tehran, Iran, Islamic Republic of
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02681029
Lead sponsor
Royan Institute
Responsible party
Sponsor
First posted
Feb 12, 2016
Start date
Nov 2015
Primary completion
Jul 2020
Completion
Sep 27, 2020
Last update
May 12, 2021

Study contacts

Hamid Gourabi, PhD
study chair · Head of Royan Institute
Tahereh Madani, MD
study director · Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
Poopak Eftekhari-Yazdi, PhD
principal investigator · Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
Nadia Jahangiri, MSc
principal investigator · Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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