Reproductive Techniques, Assisted Clinical Trial
Official title:
Randomized Clinical Trial Comparing Endometrial Transformation With Subcutaneous Progesterone (Prolutex) 25 mg/Day Versus Intramuscular Progesterone (Prontogest) 50 mg/Day
Study the endometrial predecidualization by using subcutaneous progesterone 25 mg/day versus intramuscular progesterone 50 mg/day, to determine whether there are differences in the endometrial transformation and endometrial receptivity.
The aim of this study is to compare predecidualization and endometrial receptivity as gene
expression by using subcutaneous progesterone 25 mg/day versus intramuscular progesterone 50
mg/day in healthy women of childbearing age. Both, the two drugs and the doses administered
in this clinical trial, are routine clinical practice.
A controlled ovarian stimulation will be previously performed and following routine clinical
practice for 10-12 days at standard doses of subcutaneous FSH 150-225 IU/day, according to
BMI and number of antral follicles. A GnRH antagonist shall be administered, being initiated
according to donor's follicular growth from greater or equal14 mm diameter follicles. Final
maturation shall be performed with a bolus of GnRH agonist when there exist at least 3
follicles greater or equal17 mm diameter, and therefore performing follicular puncture 36
hours after the bolus of agonist has been administered.
If the donor meets the inclusion criteria, she will be informed of the study and, if she
agrees, she will sign the informed consent. Randomization shall be performed in 2 arms; arm 1
will be administered subcutaneous progesterone 25 mg/day (Prolutex; Angelini, Spain), and arm
2, intramuscular progesterone 50 mg/day (Prontogest IBSA, Italy). In each arm 12 donors (ITT
population) will be included.
The randomization to a treatment group shall be performed the day the follicular puncture has
been programmed. To that purpose, a randomized consecutive sampling will be used by means of
assignment tables. The medication will be administered by a person not involved in the
assessments and responsible for group assignment, data centralization and drug assignment.
At day 5 (5 days after follicular puncture):endometrial thickness measurement by means of
transvaginal ultrasound and perform endometrial biopsy and take two samples: 1 sample to
Anatomical Pathology and 1 sample to Endometrial Receptivity Array (ERA).
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