Testosterone TRANSdermal Gel for Poor Ovarian Responders Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 22 May 2023
• Main ID: NCT02418572
• Date of registration: 13/04/2015
• Prospective Registration: No
• Primary sponsor: Institut Universitari Dexeus
• Public title: Testosterone TRANSdermal Gel for Poor Ovarian Responders Trial T-TRANSPORT
• Scientific title: Transdermal Testosterone Gel for Poor Ovarian Responders. A Multicenter Double-blind Placebo Controlled Randomized Trial
• Date of first enrolment: April 2015
• Target sample size: 400
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02418572
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Belgium, Denmark, Spain, Sweden, Switzerland

Contacts

• Name: Nikolaos P Polyzos, MD PhD
• Affiliation: Institut Universitari Dexeus

• Name: Nikolaos P Polyzos, MD PhD

Key inclusion & exclusion criteria

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.
Patients will be randomized according to different age groups (<36, 36-39 and =40 years
old).

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)



Age minimum: 18 Years
Age maximum: 43 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Poor Ovarian Response

Infertility

Intervention(s)

Drug: Placebo gel

Drug: Testosterone gel

Primary Outcome(s)

Clinical pregnancy [Time Frame: 7 weeks of gestation]

Secondary Outcome(s)

Ongoing pregnancy [Time Frame: 9-10 weeks of gestation]

Cycle cancellation due to poor ovarian response [Time Frame: 10 days after initiation of daily injections of HP-hMG]

Number of cycles reaching the stage of embryo transfer [Time Frame: 9 -20 days from initiation of ovarian stimulation]

Biochemical pregnancy [Time Frame: 2 weeks after embryo transfer]

Number of cycles with frozen supernumerary embryos [Time Frame: 9 -20 days from initiation of ovarian stimulation]

Number of MII oocytes retrieved [Time Frame: 9 -20 days from initiation of ovarian stimulation]

Number and quality of embryos [Time Frame: Day of embryo transfer (9 -20 days from initiation of ovarian stimulation)]

Number of oocytes retrieved [Time Frame: 9 -20 days from initiation of ovarian stimulation]

Secondary ID(s)

2014.TTRANSPORT

2014-001835-35

Source(s) of Monetary Support

Please refer to primary and secondary sponsors