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NCT Number: NCT02681029

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

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

16 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Royan Institute

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blastocyte Transferring

Procedure

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

Embryo Transferring

Procedure

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

Primary outcomes

  1. Pregnancy Rate

    Time frame: 4weeks

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

Secondary outcomes

  1. Miscarriage Rate

    Time frame: 14 days

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

  2. Implantation Rate

    Time frame: 14 days

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

  3. Ongoing pregnancy rate

    Time frame: 14 days

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

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Feb 12, 2016
Registry last updated
May 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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