Clinical Trial Comparing Endometrial Transformation With Subcutaneous Progesterone Versus Intramuscular Progesterone
Condition: Reproductive Techniques, Assisted
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): Subcutaneous progesterone; Intramuscular progesterone
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous progesterone 25 mg/day; intramuscular progesterone 50 mg/day
Other intervention name(s): Prolutex; Prontogest
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: endometrial receptivity; endometrial predecidualization; endometrial genomics; endometrial receptivity array