Study to compare the endometrial transformation with 25 mg / day of subcutaneous progesterone(Prolutex) versus 50 mg / day intramuscular progesterone (Prontogest)
- Conditions
- Infertility. Assisted Reproductive Techniques.Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
- Registration Number
- EUCTR2015-000290-12-ES
- Lead Sponsor
- Clínica IVI Barcelona
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Female age between 18 and 34 years (inclusive)
BMI between 18 and 28 kg / m2 (inclusive)
Endometrial thickness greater 7 mm on day of beginning progesterone treatment (day of follicular puncture)
Follicular maturation with bolus GnRH agonist
Egg donors who make a cycle of ovarian stimulation in the IVI Barcelona Centre
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Known allergy to progesterone preparations or its excipients
Known allergy to estrogens
Known thrombophilia
Dependence on alcohol, drugs or psychotropic
Concurrent participation in another study
Concomitant medications that may interfere with the study medication and ovarian stimulation
Not complying the requirements for egg donors according to Law 14/2006 of 26 May 2006 on Assisted Human Reproduction Techniques
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To study the predecidualización endometrial (ie, measuring the effects of progesterone in the endometrial glands and stroma in the luteal phase) and endometrial receptivity on Day 5 as gene expression, following daily administration of 25 mg / day of subcutaneous progesterone and 50 mg / day intramuscular progesterone, both for 5 days, to see if there are differences in the use of both progesterone.;Secondary Objective: To study plasma levels of progesterone, estradiol and LH on different days (Day programming follicular puncture Day follicular puncture and Day 5 of administration of progesterone / end of the study).;Primary end point(s): Endometrium predecidulacion: endometrial thickness (mm), endometrial transformation after treatment according to criteria of Noyes at al., endometrial receptivity on day 5 as gene expression profile (ERA);Timepoint(s) of evaluation of this end point: day 5
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Plasmatic levels of progesterone<br>Plasmatic levels of estradiol <br>Plasmatic levels of LH;Timepoint(s) of evaluation of this end point: Plasmatic levels of hormones: before starting treatment with progesterone (Day -2), Day of the programming of the follicular puncture, Day of the follicular puncture and the 5 th Day of the progesterone administration / ending of the study