Live birth after fresh embryo transfer vs elective embryo cryopreservation/frozen embryo transfer in women with polycystic ovary syndrome undergoing IVF (FreFro-PCOS): Study protocol for a multicenter, prospective, randomized controlled clinical trial

Yuhua Shi, Daimin Wei, Xiaoyan Liang, Yun Sun, Jiayin Liu, Yunxia Cao, Bo Zhang, Richard S. Legro, Heping Zhang, Zi Jiang Chen

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Background: Polycystic ovary syndrome (PCOS) patients are at increased risk of pregnancy complications, which may impair pregnancy outcome. Transfer of fresh embryos after superovulation may lead to abnormal implantation and placentation and further increase risk for pregnancy loss and complications. Some preliminary data suggest that elective embryo cryopreservation followed by frozen-thawed embryo transfer into a hormonally primed endometrium could result in a higher clinical pregnancy rate than that achieved by fresh embryo transfer.Methods/Design: This study is a multicenter, prospective, randomized controlled clinical trial (1:1 treatment ratio of fresh vs. elective frozen embryo transfers). A total of 1,180 infertile PCOS patients undergoing the first cycle of in vitro fertilization (IVF) or intracytoplasmic sperm injection will be enrolled and randomized into two parallel groups. Participants in group A will undergo fresh embryo transfer on day 3 after oocyte retrieval, and participants in group B will undergo elective embryo cryopreservation after oocyte retrieval and frozen-thawed embryo transfer in programmed cycles. The primary outcome is the live birth rate. Our study is powered at 80 to detect an absolute difference of 10 at the significance level of 0.01 based on a two-sided test.Discussion: We hypothesize that elective embryo cryopreservation and frozen-thawed embryo transfer will reduce the incidence of pregnancy complications and increase the live birth rate in PCOS patients who need IVF to achieve pregnancy.Trial registration: ClinicalTrials.gov Identifier: NCT01841528.

Original languageEnglish (US)
Article number154
JournalTrials
Volume15
Issue number1
DOIs
StatePublished - May 2 2014

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Polycystic Ovary Syndrome
Embryo Transfer
Cryopreservation
Live Birth
Fertilization in Vitro
Embryonic Structures
Randomized Controlled Trials
Pregnancy Complications
Oocyte Retrieval
Birth Rate
Superovulation
Placentation
Intracytoplasmic Sperm Injections
Pregnancy Rate
Pregnancy Outcome
Endometrium
Pregnancy
Incidence

All Science Journal Classification (ASJC) codes

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

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title = "Live birth after fresh embryo transfer vs elective embryo cryopreservation/frozen embryo transfer in women with polycystic ovary syndrome undergoing IVF (FreFro-PCOS): Study protocol for a multicenter, prospective, randomized controlled clinical trial",
abstract = "Background: Polycystic ovary syndrome (PCOS) patients are at increased risk of pregnancy complications, which may impair pregnancy outcome. Transfer of fresh embryos after superovulation may lead to abnormal implantation and placentation and further increase risk for pregnancy loss and complications. Some preliminary data suggest that elective embryo cryopreservation followed by frozen-thawed embryo transfer into a hormonally primed endometrium could result in a higher clinical pregnancy rate than that achieved by fresh embryo transfer.Methods/Design: This study is a multicenter, prospective, randomized controlled clinical trial (1:1 treatment ratio of fresh vs. elective frozen embryo transfers). A total of 1,180 infertile PCOS patients undergoing the first cycle of in vitro fertilization (IVF) or intracytoplasmic sperm injection will be enrolled and randomized into two parallel groups. Participants in group A will undergo fresh embryo transfer on day 3 after oocyte retrieval, and participants in group B will undergo elective embryo cryopreservation after oocyte retrieval and frozen-thawed embryo transfer in programmed cycles. The primary outcome is the live birth rate. Our study is powered at 80 to detect an absolute difference of 10 at the significance level of 0.01 based on a two-sided test.Discussion: We hypothesize that elective embryo cryopreservation and frozen-thawed embryo transfer will reduce the incidence of pregnancy complications and increase the live birth rate in PCOS patients who need IVF to achieve pregnancy.Trial registration: ClinicalTrials.gov Identifier: NCT01841528.",
author = "Yuhua Shi and Daimin Wei and Xiaoyan Liang and Yun Sun and Jiayin Liu and Yunxia Cao and Bo Zhang and Legro, {Richard S.} and Heping Zhang and Chen, {Zi Jiang}",
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Live birth after fresh embryo transfer vs elective embryo cryopreservation/frozen embryo transfer in women with polycystic ovary syndrome undergoing IVF (FreFro-PCOS) : Study protocol for a multicenter, prospective, randomized controlled clinical trial. / Shi, Yuhua; Wei, Daimin; Liang, Xiaoyan; Sun, Yun; Liu, Jiayin; Cao, Yunxia; Zhang, Bo; Legro, Richard S.; Zhang, Heping; Chen, Zi Jiang.

In: Trials, Vol. 15, No. 1, 154, 02.05.2014.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Live birth after fresh embryo transfer vs elective embryo cryopreservation/frozen embryo transfer in women with polycystic ovary syndrome undergoing IVF (FreFro-PCOS)

T2 - Study protocol for a multicenter, prospective, randomized controlled clinical trial

AU - Shi, Yuhua

AU - Wei, Daimin

AU - Liang, Xiaoyan

AU - Sun, Yun

AU - Liu, Jiayin

AU - Cao, Yunxia

AU - Zhang, Bo

AU - Legro, Richard S.

AU - Zhang, Heping

AU - Chen, Zi Jiang

PY - 2014/5/2

Y1 - 2014/5/2

N2 - Background: Polycystic ovary syndrome (PCOS) patients are at increased risk of pregnancy complications, which may impair pregnancy outcome. Transfer of fresh embryos after superovulation may lead to abnormal implantation and placentation and further increase risk for pregnancy loss and complications. Some preliminary data suggest that elective embryo cryopreservation followed by frozen-thawed embryo transfer into a hormonally primed endometrium could result in a higher clinical pregnancy rate than that achieved by fresh embryo transfer.Methods/Design: This study is a multicenter, prospective, randomized controlled clinical trial (1:1 treatment ratio of fresh vs. elective frozen embryo transfers). A total of 1,180 infertile PCOS patients undergoing the first cycle of in vitro fertilization (IVF) or intracytoplasmic sperm injection will be enrolled and randomized into two parallel groups. Participants in group A will undergo fresh embryo transfer on day 3 after oocyte retrieval, and participants in group B will undergo elective embryo cryopreservation after oocyte retrieval and frozen-thawed embryo transfer in programmed cycles. The primary outcome is the live birth rate. Our study is powered at 80 to detect an absolute difference of 10 at the significance level of 0.01 based on a two-sided test.Discussion: We hypothesize that elective embryo cryopreservation and frozen-thawed embryo transfer will reduce the incidence of pregnancy complications and increase the live birth rate in PCOS patients who need IVF to achieve pregnancy.Trial registration: ClinicalTrials.gov Identifier: NCT01841528.

AB - Background: Polycystic ovary syndrome (PCOS) patients are at increased risk of pregnancy complications, which may impair pregnancy outcome. Transfer of fresh embryos after superovulation may lead to abnormal implantation and placentation and further increase risk for pregnancy loss and complications. Some preliminary data suggest that elective embryo cryopreservation followed by frozen-thawed embryo transfer into a hormonally primed endometrium could result in a higher clinical pregnancy rate than that achieved by fresh embryo transfer.Methods/Design: This study is a multicenter, prospective, randomized controlled clinical trial (1:1 treatment ratio of fresh vs. elective frozen embryo transfers). A total of 1,180 infertile PCOS patients undergoing the first cycle of in vitro fertilization (IVF) or intracytoplasmic sperm injection will be enrolled and randomized into two parallel groups. Participants in group A will undergo fresh embryo transfer on day 3 after oocyte retrieval, and participants in group B will undergo elective embryo cryopreservation after oocyte retrieval and frozen-thawed embryo transfer in programmed cycles. The primary outcome is the live birth rate. Our study is powered at 80 to detect an absolute difference of 10 at the significance level of 0.01 based on a two-sided test.Discussion: We hypothesize that elective embryo cryopreservation and frozen-thawed embryo transfer will reduce the incidence of pregnancy complications and increase the live birth rate in PCOS patients who need IVF to achieve pregnancy.Trial registration: ClinicalTrials.gov Identifier: NCT01841528.

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