SHorter Treatment of Replacement Therapy for Frozen Embryo Transfer (FET)
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      This is a Single-centre pilot study, randomized, controlled open-label trial with the aim to
      assess the clinical pregnancy rate and the early pregnancy loss rate between two different
      schemas for frozen embryo transfer cycles stimulated with HRT. Furthermore, the investigators
      would like to evaluate the predictivity of pregnancy and early miscarriage by looking at the
      endocrinological profile (estradiol and progesterone levels) within the endometrial
      preparation and the day of embryo transfer (ET).
    

Detailed description: 
      Women planned for a FET-HRT will be asked to do a blood test day 1 of their cycle in order to
      evaluate the endocrine profile; those with basal hormonal values will receive 6 mg oral
      estradiol daily beginning from day 1 of their cycle. On day 7 of the treatment a blood test
      for the serum hormone evaluation and an ultrasound will be planned in order to evaluate the
      endometrium thickness; those who will meet the criteria (endometrium thickness ≥7mm) will be
      randomized. In the 7 days estradiol (E2) arm (A) the study coordinator will plan the FET
      after 6 days of progesterone supplementation (13 days of E2 intake). In the 14 days E2 arm
      (B) the team will plan on day 14 of treatment with E2 the serum hormone evaluation and an
      ultrasound in order to evaluate the endometrium thickness, consequently the FET will be
      planned after 6 days of progesterone supplementation (after 14 days of E2 intake).
      Furthermore, all the patients included in the study will undergo a blood test on the day of
      the transfer for the evaluation of the hormones level. For the assessment of the pregnancy a
      first blood test will take place 12 days after the ET and a blood test with an ultrasound
      will take place at 7 weeks for the evaluation of the clinical pregnancy.
    

Intervention name(s): Longer administration of estradiol (Progynova®)
Intervention type(s): Other
Intervention description(s): All women included will take exogenous hormone with daily administration of Estradiol Valerate (Progynova®), the standard dose used will be 6 mg/day (Cobo et al., n.d.). On day 7 of endometrial preparation patients will be examined with vaginal ultrasound and blood test, to evaluate the endometrial thickness and the hormones levels. In both arms the FET will take place after 6 days of Progesterone supplementation (600 mg per day, vaginal administration of Utrogestan®) According to embryo quality after warming, embryo transfer to the uterine cavity will be performed on day 5 of development under ultrasound guidance whenever possible. Following embryo transfer, luteal support will be continued with vaginally administered P (Utrogestan®). All patients 12 days after the FET will undergo the pregnancy test (blood test to evaluate hCG).
Other intervention name(s): comparing 7 vs 14 days of administration of estradiol (Progynova®) for artificially prepared endometrium in frozen embryo transfer
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment