The objective of this proof of concept clinical trial is to evaluate the impact of two different progesterone treatments for endometrial preparation (25 mg/twice-a-day, subcutaneous injection, and 200 mg/three times a day, vaginal administration) on the clinical pregnancy rate in women undergoing frozen embryo transfer (FET) at blastocyst stage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
213
25 mg/twice a day.
200 mg three times a day.
Instituto Bernabeu
Alicante, Spain
Instituto Bernabeu Madrid
Madrid, Spain
Ginemed
Seville, Spain
Clinical pregnancy rate
Time frame: 4-5 weeks after progesterone treatment start.
Serum progesterone level
Time frame: 19+/-2 days and 4-5 weeks after start progesterone treatment
Frequency of uterine contractions
n of uterine contraction/min
Time frame: on the day of Embryo transfer (i.e. 5 days after start progesterone treatment)
Positive serum pregnancy (beta-hCG) test rate
Time frame: 19+/-2 days after start progesterone treatment
Implantation rate
Time frame: 4-5 weeks after start progesterone treatment.
Ongoing pregnancy rate
Time frame: 9-11 weeks after start progesterone treatment.
Abortion rate
Time frame: 9 months after start progesterone treatment.
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