NCT02746562

Trial name or title	Study comparing outcomes between conventional IVF and a "freeze‐all"‐strategy in assisted reproductive technology
Methods	RCT Estimated enrolment: 424
Participants	Women aged 18 to 39 Inclusion criteria: AMH > 6.28 pmol/L (Roche Elecsys assay) 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 2 ovaries Can and will sign informed consent Exclusion criteria: Endometriosis stage III to IV Ovarian cysts with diameter > 30 mm at day of start of stimulation Submucosal fibroids Women with severe comorbidity (IDDM, NIDDM, gastrointestinal, cardiovascular, pulmonary, liver, or kidney disease) Dysregulation of thyroid disease Not Danish or English speaking Contraindications or allergies to use of gonadotropins or GnRH antagonists TESA Oocyte donation Previous inclusion in the study
Interventions	Freeze‐all: transfer of a frozen‐thawed blastocyst in a subsequent natural menstrual cycle Fresh embryo transfer: standard procedure
Outcomes	Cumulative live birth: measured after 1 stimulated cycle with oocyte retrieval and after use of all frozen blastocysts or after at least 1 year of follow‐up Time to pregnancy: from start of ovarian stimulation to positive hCG Ongoing pregnancy per transfer of the first blastocyst, per oocyte pick‐up, per start of ovarian stimulation, and per randomised woman Live birth after the first blastocyst transfer calculated per randomised woman, per started ovarian stimulation, per oocyte pick‐up, and per transfer Preterm birth Low birth weight Small for gestational age Large for gestational age Perinatal mortality Pre‐eclampsia Placental rupture Miscarriages, ectopic pregnancies
Starting date	May 2016
Contact information	Sacha Stormlund: sacha.stormlund.01@regionh.dk Anja Pinborg: anja.bisgaard.pinborg@regionh.dk
Notes	clinicaltrials.gov/ct2/show/record/NCT02746562