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

Evaluating the Clinical Outcomes Following Transfer of Blastocysts Cultured From Thawed Cleavage Stage Embryos at Royan Institute: A Phase 3, Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Procedure: Blastocyte Transferring; Procedure: Embryo Transferring

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.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Royan Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 37 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blastocyst transplantation; The infertile women who underwent intra- uterus transferring of blastocyst from thawed cleavage embryo	Procedure: Blastocyte Transferring; Intra-uterine transferring of blastocyst from thawed cleavage embryo in infertile women.
Placebo Comparator: Control; The infertile women who underwent intra- uterus transferring of thawed cleavage embryo.	Procedure: Embryo Transferring; Inta-uterine transferring of thawed cleavage embryo transfer in infertile women.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy Rate	Evaluation of pregnancy rate in women 4 weeks after embryos transfer (ET).	4weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Miscarriage Rate	Evaluation the miscarriage rate in women 14 days after embryo transfer (ET) with BHCG titration.	14 days
Implantation Rate	Evaluation the implantation rate in women 14 days after embryo transfer (ET) with BHCG titration..	14 days
Ongoing pregnancy rate	Evaluation the ongoing pregnancy rate in women 14 days after embryo transfer (ET) with BHCG titration..	14 days

Collaborators and Investigators

• Sponsor: Royan Institute
• Investigators: Study Director: Tahereh Madani, MD, Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran; Principal Investigator: 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

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): September 27, 2020

Study Registration Dates

• First Submitted: February 2, 2016
• First Submitted That Met QC Criteria: February 9, 2016
• First Posted (Estimate): February 12, 2016

Study Record Updates

• Last Update Posted (Actual): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 8, 2021
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Cleavage stage blastocyst transfer cryopreservation
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: Royan-Emb-023