Cumulative Live Birth Rates After Cleavage-stage Versus Blastocyst-stage Embryo Transfer

Summary

The aim of this RCT is to compare differences in the efficacy and safety between cleavage-stage embryo transfer and blastocyst-stage embryo transfer in IVF/ICSI treatment cycle, taking into account of subsequent vitrified embryo transfers. Subjects with 3 or more transferrable cleavage embryos will be randomized to the cleavage-stage or blastocyst-stage embryos transfer group. The primary outcome is cumulative live birth rate (CLBR) per patient until the first live birth from one initiated oocyte retrieval cycle, calculated using outcomes from the first three embryo transfers within 1 year after randomization.

Conditions

• Infertility

Interventions

PROCEDURE

blastocyst-stage embryo transfer

All the participants will receive a long GnRH-agonist, ultra-long GnRH-agonist, short GnRH-agonist or GnRH antagonist protocol in combination with recombinant FSH. HCG will be administered for final oocyte maturation. Patients will have a single blastocyst-stage embryos transferred. The outcomes of all the embryo transfers within 1 year after randomization will be followed up. Single embryo transfer (SET) is required for the first 3 embryo transfers within 1 year after randomization. For embryo transfers beyond the third within the 1 year, patients' treatment must follow their randomized allocation, and SET is no longer mandatory. Luteal phase support will be administered before embryo transfer. If pregnancy is confirmed, luteal phase support will be continued until 10 weeks of gestation. The follow up will be continued until 6 weeks after delivery.

PROCEDURE

cleavage-stage embryo transfer

All the participants will receive a long GnRH-agonist, ultra-long GnRH-agonist, short GnRH-agonist or GnRH antagonist protocol in combination with recombinant FSH. HCG will be administered for final oocyte maturation. Patients will have a single cleavage-stage embryos transferred. The outcomes of all the embryo transfers within 1 year after randomization will be followed up. Single embryo transfer (SET) is required for the first 3 embryo transfers within 1 year after randomization. For embryo transfers beyond the third within the 1 year, patients' treatment must follow their randomized allocation, and SET is no longer mandatory. Luteal phase support will be administered before embryo transfer. If pregnancy is confirmed, luteal phase support will be continued until 10 weeks of gestation. The follow up will be continued until 6 weeks after delivery.

Sponsors & Collaborators

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• RenJi Hospital

  collaborator OTHER

• Guangxi Maternal and Child Health Hospital

  collaborator OTHER

• Third Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• The Third Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• General Hospital of Ningxia Medical University

  collaborator OTHER

• Suzhou Municipal Hospital

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  lead OTHER

Principal Investigators

• Jiayin Liu, MD &PhD · The First Affiliated Hospital with Nanjing Medical University

• Zi-Jiang Chen, MD &PhD · Center for Reproductive Medicine, affiliated to Shandong University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-09-29

Primary Completion

2021-09-06

Completion

2022-02-18

Countries

• China

Study Locations