Clinical effect of follicular preparation with testosterone in poor ovarian response: a randomized controlled clinical trial (TESTOPRIM)

INSTITUTO DE INVESTIGACIÓN SANITARIA LA FE0 个研究点目标入组 63 人开始时间: 2017年1月25日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•- Signed Informed consent prior to the completion of any procedure related to the clinical trial.
•- Female, between 18 and 40 years at the time of randomization (both ages included).
•-Prior diagnosis of poor ovarian response (POR) according to ESHRE Bologna criteria. Patients must meet at least 2 of the following:
•Advanced maternal age (40 years or more) or any other risk factor for POR.
•A previous POR (3 oocytes or less) with a conventional ovarian stimulation protocol.
•Abnormal ovarian reserve test (RFA <5-7 or AMH 3.3-7.9 pmol / l).
•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 63
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Diagnosis of severe endometriosis (Grade III-IV).
•History of previous ovarian surgery.
•Presence of uterine malformations, corrected or not.
•Presence of uterine pathology defined as submucous myomas or endometrial polyps, documented by transvaginal ultrasound.
•Couples with severe male factor defined as REM <1 or azoospermia.
•Hydrosalpinx unilateral or bilateral uncorrected.
•Perimenopausal patients with irregular menstrual cycles.
•Concurrent untreated endocrine disorders.
•Patients who have participated in a clinical trial in a period of less than one month.
•Known allergy to the drug.
•Patients who have received androgen treatment within 3 months prior to inclusion in the study.
•BMI> 32 kg / m2

发起方

INSTITUTO DE INVESTIGACIÓN SANITARIA LA FE