Immediate Versus Delayed FET Following a Stimulated IVF Cycle

May 13, 2020 updated by: ShangHai Ji Ai Genetics & IVF Institute

A Randomized Trial Comparing the Effect of Immediate Versus Delayed Frozen-thawed Embryo Transfer 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
724

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • ShangHai JIAI Genetics&IVF Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ongoing pregnancy
Time Frame: viable pregnancy beyond gestation 12 weeks
viable pregnancy beyond gestation 12 weeks
viable pregnancy beyond gestation 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
multiple pregnancy
Time Frame: multiple pregnancy beyond gestation 12 weeks
more than one intrauterine sacs on scanning
multiple pregnancy beyond gestation 12 weeks
ectopic pregnancy
Time Frame: ectopic pregnancy during 12 weeks gestation
pregnancy outside the uterine cavity
ectopic pregnancy during 12 weeks gestation
clinical pregnancy
Time Frame: presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy
presence of intrauterine gestational sac on ultrasound
presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy
implantation rate
Time Frame: number of gestational sacs per embryo transferred during 4 weeks of pregnancy
number of gestational sacs per embryo transferred
number of gestational sacs per embryo transferred during 4 weeks of pregnancy
miscarriage
Time Frame: the loss of a pregnancy before 22 weeks gestation
the loss of a pregnancy before 22 weeks gestation
the loss of a pregnancy before 22 weeks gestation
birth weight
Time Frame: a live birth after 22 weeks gestation
birth weight of the baby delivered
a live birth after 22 weeks gestation
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.
A blood pregnancy test is performed 14 days after the FET
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
positive blood pregnancy test not followed by clinical pregnancy during 12 weeks gestation
live birth rate
Time Frame: a live birth after 22 weeks gestation
the rate of live births per cycle
a live birth after 22 weeks gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ShangHai Ji Ai Genetics & IVF Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The University of Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: XIAOXI SUN, PHD, Shanghai JiAi Genetics & IVF Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 9, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 4, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ShangHaiIVG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Embryo Transfer

Clinical Trials on immediate frozen-thawed embryo transfer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings