Clinical trial to assess de effect of testosterone in patients with poor ovarian response.

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004302-33-ES

Enrollment

Registered

2017-01-25

Start date

2017-04-07

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility with Poor Ovarian Response MedDRA version: 19.1 Level: LLT Classification code 10016398 Term: Female infertility System Organ Class: 100000004872

Interventions

Trade Name: Testim 50 mg Product Name: Testim Pharmaceutical Form: Gel INN or Proposed INN: TESTOSTERONE CAS Number: 58-22-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 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 32 kg / m2

Design outcomes

Primary

Measure	Time frame
Main Objective: Determining whether a Follicular preparation with transdermal testosterone increases the number of mature oocytes retrieved in patients diagnosed with Poor Ovarian Response and which testosterone administration regimen is more effective for this purpose.;Secondary Objective: To assess the effect of testosterone in its different regimens on other cycle parameters such as the number of follicles on the day of HCG, number of good quality embryos obtained or duration of stimulation. To investigate the effect of testosterone on cycle outcome parameters, ie clinical gestation rate and evolutionary. To compare the hormonal profiles obtained between the different groups in the different moments of measurement throughout the treatment.;Primary end point(s): Total number of mature oocytes obtained at follicular puncture.;Timepoint(s) of evaluation of this end point: 36 hours after induction of ovulation with recombinant HCG.	—

Measure

Time frame

Main Objective: Determining whether a Follicular preparation with transdermal testosterone increases the number of mature oocytes retrieved in patients diagnosed with Poor Ovarian Response and which testosterone administration regimen is more effective for this purpose.;Secondary Objective: To assess the effect of testosterone in its different regimens on other cycle parameters such as the number of follicles on the day of HCG, number of good quality embryos obtained or duration of stimulation. To investigate the effect of testosterone on cycle outcome parameters, ie clinical gestation rate and evolutionary. To compare the hormonal profiles obtained between the different groups in the different moments of measurement throughout the treatment.;Primary end point(s): Total number of mature oocytes obtained at follicular puncture.;Timepoint(s) of evaluation of this end point: 36 hours after induction of ovulation with recombinant HCG.

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Secondary

Measure	Time frame
Secondary end point(s): Number of obtained embryos Implantation rate Gestation Rate;Timepoint(s) of evaluation of this end point: 6 days after ovarian puncture.	—

Countries

Spain

Contacts

Public ContactUREC

INSTITUTO DE INVESTIGACION SANITARIA LA FE

0034961246711

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026