Clinical trial NCT02681029: The Clinical Outcomes Following Transfer of Blastocysts Cultured From Thawed Cleavage Stage Embryos
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Keywords: Cleavage stage blastocyst transfer cryopreservation
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2016-02-12
Enrollment: 220
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 37
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pregnancy Rate
timeFrame: 4weeks
Secondary outcomes:
measure: Miscarriage Rate
timeFrame: 14 days
measure: Implantation Rate
timeFrame: 14 days
measure: Ongoing pregnancy rate
timeFrame: 14 days
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
name: Tahereh Madani, MD
role: STUDY_DIRECTOR
affiliation: Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
name: Poopak Eftekhari-Yazdi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
name: Nadia Jahangiri, MSc
role: PRINCIPAL_INVESTIGATOR
References: