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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02681029
• Other study ID #: Royan-Emb-023
• Status: Completed
• Phase: Phase 3
• Start date: November 2015
• Est. completion date: September 27, 2020

Study information

• Verified date: February 2016
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: September 27, 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 37 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• Blastocyte Transferring
Intra-uterine transferring of blastocyst from thawed cleavage embryo in infertile women.
• Embryo Transferring
Inta-uterine transferring of thawed cleavage embryo transfer in infertile women.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy Rate	Evaluation of pregnancy rate in women 4 weeks after embryos transfer (ET).	4weeks
Secondary	Miscarriage Rate	Evaluation the miscarriage rate in women 14 days after embryo transfer (ET) with BHCG titration.	14 days
Secondary	Implantation Rate	Evaluation the implantation rate in women 14 days after embryo transfer (ET) with BHCG titration..	14 days
Secondary	Ongoing pregnancy rate	Evaluation the ongoing pregnancy rate in women 14 days after embryo transfer (ET) with BHCG titration..	14 days

External Links

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