Transdermal testosterone gel for poor ovarian responders. A multicenter double-blind placebo controlled randomized trial.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 400

Inclusion Criteria

Patients participating in the TTRANSPORT study will be women who are considered poor ovarian responders according to the ?Bologna criteria? (Ferrarretti et al., 2011). Patients between 18-43 years old will be eligible.

Patients should fulfill 2 out of 3 of the following criteira:
1. Age >or =40 years
2. At least 1 previous stimulated IVF/ICSI cycle with ?3 oocytes retrieved
3. Low ovarian reserve markers (antral follicle count <7 or antimullerian hormone levels<1.1ng/ml)

Women < 40 years old with normal AFC or AMH who underwent at least 2 previous stimulated IVF/ICSI cycles with ? 3 oocytes retrieved after maximum stimulation for IVF/ICSI, will also be considered eligible
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 400
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Perimenopausal women with amenorrhea not having a regular cycle
2.Uterine abnormalities
3.Recent history of any current untreated endocrine abnormality
4.Unilateral or bilateral hydrosalpinx (visible on USS, unless clipped)
5.Contraindications for the use of gonadotropins
6.Recent history of severe disease requiring regular treatment
7.Use of androgens during the last 3 months
8.Patients with shBG values <20nmol/L or >160nmol/L
9.Azoospermia ( sperm derived through TESE)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the study is to determine whether pre-treatment with transdermal testosterone gel (TTG) results in significantly higher clinical pregnancy rates compared with placebo in poor ovarian responders fulfilling the Bologna criteria after treatment with HP-hMG in a long GnRH agonist protocol.;Secondary Objective: Secondary objectives are to evaluate whether testosterone pretreatment may improve ovarian response and embryo quality in women undergoing ovarian stimulation for IVF/ICSI and whether it may have an impact on ovarian reserve markers such as antimullerian hormone and antral follicle count.;Primary end point(s): Clinical pregnancy rate defined as the presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 7 weeks of gestation;Timepoint(s) of evaluation of this end point: 7 weeks of gestation

Secondary Outcome Measures

Name	Time	Method

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