NCT02746562

Brief Summary

The purpose of this study is to compare conventional fresh embryo transfer with a "freeze all and transfer later strategy" in assisted reproductive technology in terms of ongoing pregnancy rates, live birth rates as well as perinatal outcomes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
424

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

April 2, 2019

Status Verified

April 1, 2019

Enrollment Period

2.7 years

First QC Date

April 18, 2016

Last Update Submit

April 1, 2019

Conditions

Infertility

Keywords

Assisted reproductionIn vitro fertilisationFrozen embryo transfer (FET)

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rates

    Outcome measured per transfer of the first blastocyst, per oocyte pick-up, per start of ovarian stimulation and per randomized patient.

    Two years

Secondary Outcomes (16)

  • Live birth rates

    Two years

  • Cumulative live birth rates

    Two years

  • Number of cycles with no embryo transfer

    Two years

  • Time-to-pregnancy

    Two years

  • Time-to-delivery

    Three years

  • +11 more secondary outcomes

Study Arms (2)

Freeze all

EXPERIMENTAL

Transfer of a frozen, thawed blastocyst in a subsequent natural menstrual cycle

Procedure: Freeze all

Fresh embryo transfer

NO INTERVENTION

Standard procedure

Interventions

Freeze allPROCEDURE

Freezing of all blastocyst stage embryos with thawing and transfer in a subsequent natural cycle

Freeze all

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • AMH (Anti-Müllerian hormone) \> 6.28 pmol/L (Roche Elecsys assay)
  • Female age 18 years to less than 40 years
  • , 2 or 3 IVF/ICSI cycle with oocyte aspiration
  • Regular menstrual cycle between 24 and 35 days
  • BMI between 18 and 35
  • Two ovaries
  • Can and will sign informed consent

You may not qualify if:

  • Endometriosis stage III to IV
  • Ovarian cysts with diameter \> 30 mm at day of start of stimulation
  • Submucosal fibroids
  • Women with severe co-morbidity (IDDM, NIDDM, gastrointestinal, cardiovascular, pulmonary, liver or kidney disease)
  • Dysregulation of thyroid disease
  • Not danish or English speaking women
  • Contraindications or allergies to use of Gonadotrophins or GnRH antagonists
  • TESA (testicular sperm aspiration)
  • OD (oocyte donation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rigshospitalet

Copenhagen, Denmark

RECRUITING

University Hospital Hvidovre

Hvidovre, Denmark

RECRUITING

Related Publications (5)

  • Pilegaard SP, Schmidt L, Stormlund S, Koert E, Bogstad JW, Praetorius L, Nielsen HS, la Cour Freiesleben N, Sopa N, Klajnbard A, Humaidan P, Bergh C, Englund ALM, Lossl K, Pinborg A. Psychosocial wellbeing shortly after allocation to a freeze-all strategy compared with a fresh transfer strategy in women and men: a sub-study of a randomized controlled trial. Hum Reprod. 2023 Nov 2;38(11):2175-2186. doi: 10.1093/humrep/dead188.

    PMID: 37742131DERIVED

  • Alexopoulou E, Stormlund S, Lossl K, Praetorius L, Sopa N, Bogstad JW, Mikkelsen AL, Forman J, la Cour Freiesleben N, Vikkelso Jeppesen J, Bergh C, Al Humaidan PSH, Grondahl ML, Zedeler A, Pinborg AB. Embryo Morphokinetics and Blastocyst Development After GnRH Agonist versus hCG Triggering in Normo-ovulatory Women: a Secondary Analysis of a Multicenter Randomized Controlled Trial. Reprod Sci. 2021 Oct;28(10):2972-2981. doi: 10.1007/s43032-021-00564-9. Epub 2021 Apr 13.

    PMID: 33847977DERIVED

  • Zaat T, Zagers M, Mol F, Goddijn M, van Wely M, Mastenbroek S. Fresh versus frozen embryo transfers in assisted reproduction. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD011184. doi: 10.1002/14651858.CD011184.pub3.

    PMID: 33539543DERIVED

  • Stormlund S, Sopa N, Zedeler A, Bogstad J, Praetorius L, Nielsen HS, Kitlinski ML, Skouby SO, Mikkelsen AL, Spangmose AL, Jeppesen JV, Khatibi A, la Cour Freiesleben N, Ziebe S, Polyzos NP, Bergh C, Humaidan P, Andersen AN, Lossl K, Pinborg A. Freeze-all versus fresh blastocyst transfer strategy during in vitro fertilisation in women with regular menstrual cycles: multicentre randomised controlled trial. BMJ. 2020 Aug 5;370:m2519. doi: 10.1136/bmj.m2519.

    PMID: 32759285DERIVED

  • Stormlund S, Lossl K, Zedeler A, Bogstad J, Praetorius L, Nielsen HS, Bungum M, Skouby SO, Mikkelsen AL, Andersen AN, Bergh C, Humaidan P, Pinborg A. Comparison of a 'freeze-all' strategy including GnRH agonist trigger versus a 'fresh transfer' strategy including hCG trigger in assisted reproductive technology (ART): a study protocol for a randomised controlled trial. BMJ Open. 2017 Jul 31;7(7):e016106. doi: 10.1136/bmjopen-2017-016106.

    PMID: 28760794DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Anja Bisgaard Pinborg, MD, DMSc

    Fertility Clinic, Obstetrical and Gynecological department, Hvidovre Hospital

    STUDY DIRECTOR

Central Study Contacts

Sacha Stormlund, MD

CONTACT

sacha.stormlund.01@regionh.dk

Anja Bisgaard Pinborg, MD, DMSc

CONTACT

anja.bisgaard.pinborg@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, MD, DMSc

Study Record Dates

First Submitted

April 18, 2016

First Posted

April 21, 2016

Study Start

May 1, 2016

Primary Completion

January 1, 2019

Study Completion

September 1, 2019

Last Updated

April 2, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)