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Fertilization in VitroNCT03201783

Immediate Versus Delayed FET Following a Stimulated IVF Cycle

A study testing immediate frozen-thawed embryo transfer and delayed frozen-thawed embryo transfer in people with Fertilization in Vitro and Embryo Transfer, run by ShangHai Ji Ai Genetics & IVF Institute at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 43 years, women only
Conditions the study is for
Fertilization in Vitro, Embryo Transfer
What is being tested?
immediate frozen-thawed embryo transfer and delayed frozen-thawed embryo transfer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
724 participants
Where
1 siteChina
Study dates
9 Aug 2017to 31 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 43 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • ShangHai JIAI Genetics&IVF Institute

    Shanghai

Other trials in China

About this study

Official title: 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.

Being tested
immediate frozen-thawed embryo transfer, delayed frozen-thawed embryo transfer
Keywords
frozen-thawed embryo transfer, time interval

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • immediate frozen-thawed embryo transferOther

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

  • delayed frozen-thawed embryo transferOther

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

Study groups in NCT03201783
Study groupRoleWhat they receive
immediate groupOtherthe intervention: immediate frozen-thawed embryo transfer (FET) which means FET will be performed in the first cycle following the stimulated IVF cycle
Receives: Other: immediate frozen-thawed embryo transfer
delayed groupOtherthe intervention: delayed frozen-thawed embryo transfer (FET) which means FET will be performed at least in the second cycle following the stimulated IVF cycle
Receives: Other: delayed frozen-thawed embryo transfer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ongoing pregnancy

    viable pregnancy beyond gestation 12 weeks

    Measured: viable pregnancy beyond gestation 12 weeks

Secondary outcomes (9)

  1. Positive hCG level

    the result of serum β-hCG ≥10 mIU/mL.

    Measured: A blood pregnancy test is performed 14 days after the FET

  2. clinical pregnancy

    presence of intrauterine gestational sac on ultrasound

    Measured: presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy

  3. biochemical pregnancy:

    positive blood pregnancy test not followed by clinical pregnancy

    Measured: positive blood pregnancy test not followed by clinical pregnancy during 12 weeks gestation

  4. implantation rate

    number of gestational sacs per embryo transferred

    Measured: number of gestational sacs per embryo transferred during 4 weeks of pregnancy

  5. multiple pregnancy

    more than one intrauterine sacs on scanning

    Measured: multiple pregnancy beyond gestation 12 weeks

  6. ectopic pregnancy

    pregnancy outside the uterine cavity

    Measured: ectopic pregnancy during 12 weeks gestation

  7. miscarriage

    the loss of a pregnancy before 22 weeks gestation

    Measured: the loss of a pregnancy before 22 weeks gestation

  8. live birth rate

    the rate of live births per cycle

    Measured: a live birth after 22 weeks gestation

  9. birth weight

    birth weight of the baby delivered

    Measured: a live birth after 22 weeks gestation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2017
  2. Study start9 Aug 2017
  3. Primary completion4 Mar 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
724 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03201783
Sponsor's protocol ID
ShangHaiIVG
Status last verified
Sep 2019
First submitted
23 Jun 2017
Last updated
14 May 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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).

Publications

  • Santos-Ribeiro S, Siffain J, Polyzos NP, van de Vijver A, van Landuyt L, Stoop D, Tournaye H, Blockeel C. To delay or not to delay a frozen embryo transfer after a failed fresh embryo transfer attempt? Fertil Steril. 2016 May;105(5):1202-1207.e1. doi: 10.1016/j.fertnstert.2015.12.140. Epub 2016 Jan 21.

    PubMed 26806686

  • Santos-Ribeiro S, Polyzos NP, Lan VT, Siffain J, Mackens S, Van Landuyt L, Tournaye H, Blockeel C. The effect of an immediate frozen embryo transfer following a freeze-all protocol: a retrospective analysis from two centres. Hum Reprod. 2016 Nov;31(11):2541-2548. doi: 10.1093/humrep/dew194. Epub 2016 Sep 8.

    PubMed 27609984

  • Lattes K, Checa MA, Vassena R, Brassesco M, Vernaeve V. There is no evidence that the time from egg retrieval to embryo transfer affects live birth rates in a freeze-all strategy. Hum Reprod. 2017 Feb;32(2):368-374. doi: 10.1093/humrep/dew306. Epub 2016 Dec 16.

    PubMed 27986819

  • Volodarsky-Perel A, Eldar-Geva T, Holzer HE, Schonberger O, Reichman O, Gal M. Cryopreserved embryo transfer: adjacent or non-adjacent to failed fresh long GnRH-agonist protocol IVF cycle. Reprod Biomed Online. 2017 Mar;34(3):267-273. doi: 10.1016/j.rbmo.2016.11.013. Epub 2016 Dec 16.

    PubMed 28041829

  • Li H, Sun X, Yang J, Li L, Zhang W, Lu X, Chen J, Chen H, Yu M, Fu W, Peng X, Chen J, Ng EHY. Immediate versus delayed frozen embryo transfer in patients following a stimulated IVF cycle: a randomised controlled trial. Hum Reprod. 2021 Jun 18;36(7):1832-1840. doi: 10.1093/humrep/deab071.

    PubMed 33885131

  • Li H, Li L, Lu X, Sun X, Ng EHY. Comparison of the effect of immediate versus delayed transfer following a stimulated IVF cycle on the ongoing pregnancy rate of frozen-thawed embryo transfer cycles: a study protocol for a randomised controlled trial. BMJ Open. 2018 May 17;8(5):e020507. doi: 10.1136/bmjopen-2017-020507.

    PubMed 29773699

Questions about this trial

What is this clinical trial studying?

A study testing immediate frozen-thawed embryo transfer and delayed frozen-thawed embryo transfer in people with Fertilization in Vitro and Embryo Transfer, run by ShangHai Ji Ai Genetics & IVF Institute at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ongoing pregnancy (time frame: viable pregnancy beyond gestation 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03201783, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2020.

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