NCT02681029

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2015

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2020

Completed
Last Updated

May 12, 2021

Status Verified

February 1, 2016

Enrollment Period

4.7 years

First QC Date

February 2, 2016

Last Update Submit

May 8, 2021

Conditions

Infertility

Keywords

Cleavage stage blastocyst transfer cryopreservation

Outcome Measures

Primary Outcomes (1)

  • Pregnancy Rate

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

    4weeks

Secondary Outcomes (3)

  • Miscarriage Rate

    14 days

  • Implantation Rate

    14 days

  • Ongoing pregnancy rate

    14 days

Study Arms (2)

Blastocyst transplantation

EXPERIMENTAL

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

Procedure: Blastocyte Transferring

Control

PLACEBO COMPARATOR

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

Procedure: Embryo Transferring

Interventions

Blastocyte TransferringPROCEDURE

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

Blastocyst transplantation
Embryo TransferringPROCEDURE

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

Control

Eligibility Criteria

Age16 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Publications (1)

  • Madani T, Jahangiri N, Yahyaei A, Vesali S, Zarei M, Eftekhari-Yazdi P. Does The Culture of Post-Thawed Cleavage-Stage Embryos to Blastocysts Improve Infertility Treatment Outcomes of Frozen-Thawed Embryo Transfer Cycles? A Randomised Clinical Trial. Int J Fertil Steril. 2024 Feb 2;18(2):146-152. doi: 10.22074/ijfs.2023.560780.1357.

    PMID: 38368518DERIVED

Related Links

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Hamid Gourabi, PhD

    Head of Royan Institute

    STUDY CHAIR

  • Tahereh Madani, MD

    Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran

    STUDY DIRECTOR

  • Poopak Eftekhari-Yazdi, PhD

    Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran

    PRINCIPAL INVESTIGATOR

  • Nadia Jahangiri, MSc

    Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2016

First Posted

February 12, 2016

Study Start

November 1, 2015

Primary Completion

July 1, 2020

Study Completion

September 27, 2020

Last Updated

May 12, 2021

Record last verified: 2016-02

Locations

IR(1)