Study Comparing Outcomes Between Conventional IVF and a "Freeze-all"-Strategy in Assisted Reproductive Technology
NCT ID: NCT02746562
Last Updated: 2019-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
424 participants
INTERVENTIONAL
2016-05-31
2019-09-30
Brief Summary
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Detailed Description
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In total 5 clinics in Denmark and Sweden will be participating in the recruitment of patients for the study.
The patients will be screened and randomized computerized on cycle day 2 or 3 and allocated to one of the two study arms:
I: hCG (human chorion gonadotrophin) arm with traditional hCG triggering and fresh blastocyst transfer II: GnRH (gonadotropin-releasing hormone)- agonist triggering arm with blastocyst cryopreservation and subsequent transfer in a subsequent natural cycle.
The randomization will be done after the decision of gonadotrophin (rFSH/hMG) starting dose, and both doctor and patient will be blinded to the randomization until the day of hCG/agonist trigger. Both groups will be stimulated in a short GnRH antagonist protocol. The ovarian stimulation The gonadotrophin stimulation is performed according to the general standards in each of the clinics and can be altered according to the ovarian response with a maximum of 300 IU.
Blood samples are collected at baseline before the first gonadotrophin injection and at day of hCG injection and further blood samples in the luteal phase will be collected for a small subgroup of patients. All blood samples will be kept at the Biobank for the study at Hvidovre Hospital.
Women in both arms will furthermore be requested to fill out a physical discomfort and a quality of life questionnaire at two different visits. Additionally the men will be asked to fill out quality of life questionnaires.
Comprehensive sonography will be performed at the start of ovulation with details on each ovary. Ultrasound examination is performed on cycle day 2-3, at stimulation day 6 and thereafter every 2-3 days until ovulation is inducted.
On the day of oocyte retrieval the randomization is unblinded. The oocytes are fertilized by either IVF or ICSI and cultured individually according to the normal procedures in the clinics.
If the patient is allocated to the "Fresh embryo transfer"-group the best quality blastocyst will be transferred on day five after oocyte pick-up, if a blastocyst is developed. Surplus good quality blastocysts are vitrified on day five or six.
For patients in the "Freeze all" group all embryos of good quality are vitrified at the blastocyst stage day 5 in the stimulated cycle according to the criteria for freezing blastocysts in each clinic. The highest quality embryo is selected and marked and will be the first one to be thawed after at least one mentrual cycle that is considered as a wash out period. Embryo transfer is performed 6-7 days after hCG injection in the blastocyst transfer cycle in this group.
A serum beta-hCG test is performed 11 days after blastocyst transfer, and clinical pregnancy is confirmed by transvaginal ultrasound 3 to 4 weeks after a positive serum-hCG test.
A follow-up of all pregnancies will be performed within three months after delivery or termination of pregnancy on predefined information sheets. All pregnancies resulting from blastocysts retrieved and thawed according to this study protocol will be followed from study inclusion and one year onwards.
All data will be collected in a single database and all participants will be anonymized by way of an identificationcode. The biobank will be closed and all samples destroyed after 5 years of the conclusion of the study at the latest.
The study is a superiority study with 424 (212 in each arm) patients required to have an 80 % chance of detecting, as significant at the 5 % level, a decrease in the primary outcome measure from 30 % in the control group to 43 % in the experimental group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Freeze all
Transfer of a frozen, thawed blastocyst in a subsequent natural menstrual cycle
Freeze all
Freezing of all blastocyst stage embryos with thawing and transfer in a subsequent natural cycle
Fresh embryo transfer
Standard procedure
No interventions assigned to this group
Interventions
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Freeze all
Freezing of all blastocyst stage embryos with thawing and transfer in a subsequent natural cycle
Eligibility Criteria
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Inclusion Criteria
* Female age 18 years to less than 40 years
* 1, 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
* 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)
* Previous inclusion in the study
18 Years
39 Years
FEMALE
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Herlev Hospital
OTHER
Holbaek Sygehus
OTHER
Skane University Hospital
OTHER
Sahlgrenska University Hospital
OTHER
Regional Hospital Skive
UNKNOWN
Dexeus University Hospital Barcelona
UNKNOWN
Anja Bisgaard Pinborg
OTHER
Responsible Party
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Anja Bisgaard Pinborg
Professor, MD, DMSc
Principal Investigators
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Anja Bisgaard Pinborg, MD, DMSc
Role: STUDY_DIRECTOR
Fertility Clinic, Obstetrical and Gynecological department, Hvidovre Hospital
Locations
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Rigshospitalet
Copenhagen, , Denmark
University Hospital Hvidovre
Hvidovre, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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1600-1116
Identifier Type: -
Identifier Source: org_study_id
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