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Comparison of Clinical Outcomes in Fresh Cycle With Single Blastocyst Stage and Double Cleavage-stage Embryos: a Single-center, Non-blind, Randomized Controlled Study

Primary Purpose

Infertility, Female

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
double cleavage-stage or single blastocyst stage embryos transfer
Sponsored by
Women's Hospital School Of Medicine Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: patients with a diagnosis of primary or secondary infertility with a clinical indication for IVF/intracytoplasmic sperm injection (ICSI) under 38 years of age number of AFC≥6, AMH>1.1ng/ml no adverse factors of fresh embryo transplantation (evaluation by an experienced reproductive physician) number of available embryos(day 3)≥4 informed consent Exclusion Criteria: PGT with adenomyosis, endometrial compression by uterine fibroids, intrauterine adhesion, endometrial polyps and other factors unsuitable for fresh cycle transplantation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Double Cleavage-stage Embryos transfer

    Single Blastocyst Stage Embryos transfer

    Arm Description

    In group A, two embryos at cleavage stage were transplanted on the third day after oocyte retrieval.

    Group B was graded by Gardner blastocyst grading method, and one blastocyst was transplanted on the 5th or 6th day after oocyte retrieval.

    Outcomes

    Primary Outcome Measures

    live birth rate per fresh transfer
    live birth, which was defined as the presence of a live fetus (or feti) after the 24th week of gestational age

    Secondary Outcome Measures

    Full Information

    First Posted
    November 20, 2022
    Last Updated
    November 20, 2022
    Sponsor
    Women's Hospital School Of Medicine Zhejiang University
    Collaborators
    ORGANON (SHANGHAI) PHARMACEUTICAL TECHNOLOGY CO., LTD.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05632731
    Brief Title
    Comparison of Clinical Outcomes in Fresh Cycle With Single Blastocyst Stage and Double Cleavage-stage Embryos: a Single-center, Non-blind, Randomized Controlled Study
    Official Title
    Comparison of Clinical Outcomes in Fresh Cycle With Single Blastocyst Stage and Double Cleavage-stage Embryos: a Single-center, Non-blind, Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2022 (Anticipated)
    Primary Completion Date
    August 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Women's Hospital School Of Medicine Zhejiang University
    Collaborators
    ORGANON (SHANGHAI) PHARMACEUTICAL TECHNOLOGY CO., LTD.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In traditional assisted reproductive technology (ART), choosing multiple embryo transfer to get a high clinical pregnancy rate while increasing the risk of multiple pregnancies. Research showed that the single-cleavage embryo transfer could not simultaneously meet the dual requirements of maintaining pregnancy rate and reducing the multiple pregnancy rate.The purpose of this study was to observe the clinical outcome between double cleavage embryo transfers and single blastocyst transfers in fresh cycle through RCT study with GnRH antagonist protocol.
    Detailed Description
    In traditional assisted reproductive technology (ART), choosing multiple embryo transfer to get a high clinical pregnancy rate while increasing the risk of multiple pregnancies. Research showed that in the fresh cleavage embryo transfer cycle, the clinical pregnancy rate increased with the increase of the number of high-quality embryos transferred, and so did the multiple pregnancy rate, suggesting that the single-cleavage embryo transfer could not simultaneously meet the dual requirements of maintaining pregnancy rate and reducing the multiple pregnancy rate. Compared with the embryo at cleavage stage, blastocyst culture is a process of survival of the fittest, which is physiologically more synchronized with endometrial development and can improve embryo implantation rate. The existing clinical research analysis is mostly limited to the down-regulating regimen, while the RCT study of high-quality with GnRH antagonist protocol is few. Therefore, the purpose of this study was to observe the clinical outcome between double cleavage embryo transfers and single blastocyst transfers in fresh cycle through RCT study with GnRH antagonist protocol.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility, Female

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    1236 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Double Cleavage-stage Embryos transfer
    Arm Type
    Other
    Arm Description
    In group A, two embryos at cleavage stage were transplanted on the third day after oocyte retrieval.
    Arm Title
    Single Blastocyst Stage Embryos transfer
    Arm Type
    Other
    Arm Description
    Group B was graded by Gardner blastocyst grading method, and one blastocyst was transplanted on the 5th or 6th day after oocyte retrieval.
    Intervention Type
    Procedure
    Intervention Name(s)
    double cleavage-stage or single blastocyst stage embryos transfer
    Intervention Description
    Infertile women requesting in vitro fertilization treatment were randomly assigned to undergo transfer of either two cleavage-stage embryos or a single blastocyst-stage embryo.
    Primary Outcome Measure Information:
    Title
    live birth rate per fresh transfer
    Description
    live birth, which was defined as the presence of a live fetus (or feti) after the 24th week of gestational age
    Time Frame
    2 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    38 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with a diagnosis of primary or secondary infertility with a clinical indication for IVF/intracytoplasmic sperm injection (ICSI) under 38 years of age number of AFC≥6, AMH>1.1ng/ml no adverse factors of fresh embryo transplantation (evaluation by an experienced reproductive physician) number of available embryos(day 3)≥4 informed consent Exclusion Criteria: PGT with adenomyosis, endometrial compression by uterine fibroids, intrauterine adhesion, endometrial polyps and other factors unsuitable for fresh cycle transplantation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yimin Zhu, Dr
    Phone
    0571-89992071
    Email
    zhuyim@zju.edu.cn

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of Clinical Outcomes in Fresh Cycle With Single Blastocyst Stage and Double Cleavage-stage Embryos: a Single-center, Non-blind, Randomized Controlled Study

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