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

Phase 1

• Conditions: Infertility in women with poor ovarian response to stimulation for IVF/ICSI; MedDRA version: 20.0Level: PTClassification code 10021928Term: Infertility femaleSystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2014-001835-35-BE
• Lead Sponsor: Fundación Santiago Dexeus Font (Dexeus)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-02
• Last Update Posted: 18 July 2023

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” (Ferraretti et al., 2011).
Subjects must fulfil the following criteria to be included in the study:
1. All subjects must sign the Informed consent documents prior to screening evaluations.
2.Age: between 18-43 years old.
3.One of the features below:
Infertile female <40 years old with
i.= 3 oocytes in a previous cycle and AFC <7 OR
ii.ovarian surgery/chemotherapy and AFC<7 OR
iii.= 3 oocytes in at least 2 previous cycles with =300IU gonadotropins
Infertile female =40 years old with
i. = 3 oocytes in a previous cycle OR
ii. AFC <7.

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.Basal FSH >20 IU/l
3.Uterine malformations
4.Recent history of any current untreated endocrine abnormality
5.Unilateral or bilateral hydrosalpinx (visible on USS, unless clipped)
6.Contraindications for the use of gonadotropins
7.Recent history of severe disease requiring regular treatment
8.Use of androgens during the last 3 months
9.Patients with SHBG values <20nmol/L or >160nmol/L
10.Azoospermia (sperm derived through FNA or TESE)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified