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NCT Number: NCT03201783

Immediate Versus Delayed FET Following a Stimulated IVF Cycle

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.

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Key information

Conditions

Fertilization in Vitro Embryo Transfer

Age range

20 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ShangHai JIAI Genetics&IVF Institute

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

immediate frozen-thawed embryo transfer

Other

Frozen-thawed embryo transfer will be performed in the first cycle following the stimulated IVF cycle

delayed frozen-thawed embryo transfer

Other

Frozen-thawed embryo transfer will be performed at least in the second cycle following the stimulated IVF cycle

Primary outcomes

  1. ongoing pregnancy

    Time frame: viable pregnancy beyond gestation 12 weeks

    viable pregnancy beyond gestation 12 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

ShangHai Ji Ai Genetics & IVF Institute

Other

Collaborators

  • The University of Hong Kong

Registry information

Official study title

A Randomized Trial Comparing the Effect of Immediate Versus Delayed Frozen-thawed Embryo Transfer Following a Stimulated IVF Cycle

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 28, 2017
Registry last updated
May 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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