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Immediate Versus Delayed FET Following a Stimulated IVF Cycle

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ClinicalTrials.gov Identifier: NCT03201783
Recruitment Status : Completed
First Posted : June 28, 2017
Last Update Posted : May 14, 2020
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by (Responsible Party):
ShangHai Ji Ai Genetics & IVF Institute

Brief Summary:
Information regarding the optimal timing for frozen-thawed embryo transfer (FET) following a stimulated in vitro fertilization (IVF) is lacking. One option is to perform FET in the first cycle following the stimulated IVF cycle, i.e. immediate transfer. Another option is to postpone FET for at least one menstrual cycle, i.e. delayed transfer. This randomized study aims to compare the ongoing pregnancy rate of immediate versus delayed FET following a stimulated IVF cycle.

Condition or disease Intervention/treatment Phase
Fertilization in Vitro Embryo Transfer Other: immediate frozen-thawed embryo transfer Other: delayed frozen-thawed embryo transfer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 724 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: No masking because of the nature of the intervention
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing the Effect of Immediate Versus Delayed Frozen-thawed Embryo Transfer Following a Stimulated IVF Cycle
Actual Study Start Date : August 9, 2017
Actual Primary Completion Date : March 4, 2019
Actual Study Completion Date : December 31, 2019

Arm Intervention/treatment
immediate group
the intervention: immediate frozen-thawed embryo transfer (FET) which means FET will be performed in the first cycle following the stimulated IVF cycle
Other: immediate frozen-thawed embryo transfer
Frozen-thawed embryo transfer will be performed in the first cycle following the stimulated IVF cycle

delayed group
the intervention: delayed frozen-thawed embryo transfer (FET) which means FET will be performed at least in the second cycle following the stimulated IVF cycle
Other: delayed frozen-thawed embryo transfer
Frozen-thawed embryo transfer will be performed at least in the second cycle following the stimulated IVF cycle




Primary Outcome Measures :
  1. ongoing pregnancy [ Time Frame: viable pregnancy beyond gestation 12 weeks ]
    viable pregnancy beyond gestation 12 weeks


Secondary Outcome Measures :
  1. Positive hCG level [ Time Frame: A blood pregnancy test is performed 14 days after the FET ]
    the result of serum β-hCG ≥10 mIU/mL.

  2. clinical pregnancy [ Time Frame: presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy ]
    presence of intrauterine gestational sac on ultrasound

  3. biochemical pregnancy: [ Time Frame: positive blood pregnancy test not followed by clinical pregnancy during 12 weeks gestation ]
    positive blood pregnancy test not followed by clinical pregnancy

  4. implantation rate [ Time Frame: number of gestational sacs per embryo transferred during 4 weeks of pregnancy ]
    number of gestational sacs per embryo transferred

  5. multiple pregnancy [ Time Frame: multiple pregnancy beyond gestation 12 weeks ]
    more than one intrauterine sacs on scanning

  6. ectopic pregnancy [ Time Frame: ectopic pregnancy during 12 weeks gestation ]
    pregnancy outside the uterine cavity

  7. miscarriage [ Time Frame: the loss of a pregnancy before 22 weeks gestation ]
    the loss of a pregnancy before 22 weeks gestation

  8. live birth rate [ Time Frame: a live birth after 22 weeks gestation ]
    the rate of live births per cycle

  9. birth weight [ Time Frame: a live birth after 22 weeks gestation ]
    birth weight of the baby delivered



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women aged ≤43 years at the time of IVF/ICSI treatment Undergoing IVF with a standard stimulation At least one frozen embryo or blastocyst The first FET cycle following ovarian stimulation in IVF/ICSI

Exclusion Criteria:

  • Use of mild stimulation or natural cycle for IVF/ICSI treatment Severe ovarian hyperstimulation syndrome during IVF/ICSI treatment Preimplantation genetic diagnosis treatment Use of donor oocytes Presence of hydrosalpinx which is not surgically treated or endometrial polyp on scanning during ovarian stimulation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201783


Locations
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China
ShangHai JIAI Genetics&IVF Institute
Shanghai, China
Sponsors and Collaborators
ShangHai Ji Ai Genetics & IVF Institute
The University of Hong Kong
Investigators
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Principal Investigator: XIAOXI SUN, PHD Shanghai JiAi Genetics & IVF Institute
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ShangHai Ji Ai Genetics & IVF Institute
ClinicalTrials.gov Identifier: NCT03201783    
Other Study ID Numbers: ShangHaiIVG
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results after deidentification (text, tables, figures, and appendices) and study protocol will be shared. Data will be available when beginning 3 months and ending 5 years following article publication. To achieve aims in the approved proposal, researchers who provide a methodologically sound proposal will be shared with.Data will be made available by the following way. Proposals should be directed to lihe198900@163.com. And data are available for 5 years at a third party website (link to be included after the article publication).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ShangHai Ji Ai Genetics & IVF Institute:
frozen-thawed embryo transfer
time interval