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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02681029

Enrollment

220

Registered

2016-02-12

Start date

2015-11-30

Completion date

2020-09-27

Last updated

2021-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Cleavage stage blastocyst transfer cryopreservation

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.

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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

16 Years to 37 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026