Study, with random assignment of treatment, to assess whether different durations and different u-FSH medication dosages produce different results in treating male infertility

Randomized controlled phase IIb-III clinical trial to assess the effectiveness of different regimens with u-FSH in the infertile male - UFO – UROFOLLITROPIN IN OLIGOZOOSPERMIA

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004034-14-IT

Enrollment

172

Registered

2021-06-01

Start date

2018-10-11

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Male infertility MedDRA version: 20.0 Level: LLT Classification code 10065945 Term: Male sterility System Organ Class: 100000004872

Interventions

Trade Name: FOSTIMON - 150 UI POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONCINO + 1 FIALA Product Name: FOSTIMON - 150 UI Product Code: [FOSTIMON- 150 UI] Pharmaceutical Form: Powder and solve

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Age between 20 and 50 years - Caucasian Ethnicity - Oligozoospermia (total sperm count =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Azoospermia - Endocrine Disorders - Genetic causes of infertility (chromosomal, microdeletions Cr. Y, CFTR mutations) - Varicocele, cryptorchidism, infections, presence of antisperm antibodies, obstruction of the seminal ducts - FSH = 8 IU / L - Hypogonadism - Systemic Diseases, testicular tumors - Known causes of infertility in the partner with obstruction / absence of the tube, endocrine abnormalities, endometriosis, PCOS, oligo-amenorrhea, age = 40 years

Design outcomes

Primary

Measure	Time frame
Main Objective: To verify if the new treatment schemes proposed in arms 1-3 are able to improve the number of spontaneous pregnancies and pregnancies obtained by medically assisted procreation techniques (PMA) within 36 weeks from the beginning of the therapy in comparison with the control arm;Secondary Objective: To verify, as a result of the different treatment schemes with FSH, at 12 and 24 weeks of therapy and at the 36th week (follow-up), the following changes: 1. Increased plasma concentrations of FSH; 2. If at 12 weeks the subjects treated with 300 IU, 3 times a week have on average a Total Motile Sperm (TMS) higher than that of the subjects treated with a lower dosage (150 IU, 3 times a week) (subjects arm 3 vs arm 1, 2 and control); 3. At 24 weeks of treatment which of the 4 schemes has a better outcome in terms of average TMS increase and if this result is higher than the standard one; 4. After 12 weeks after the suspension of treatment, which of the 4 schemes shows an average of less decrease in TMS and which shows better performance than the standard scheme. 5. Improvement of other seminal parameters (such as morphology and viability).;Primary end point(s): To check if the new treatment schemes proposed in arms 1-3 are able to improve the number of spontaneous pregnancies and pregnancies obtained by medically assisted procreation techniques (PMA) within 36 weeks from the beginning of the therapy in comparison with the control arm;Timepoint(s) of evaluation of this end point: Within 36 weeks from the beginning of therapy	—

Measure

Time frame

Main Objective: To verify if the new treatment schemes proposed in arms 1-3 are able to improve the number of spontaneous pregnancies and pregnancies obtained by medically assisted procreation techniques (PMA) within 36 weeks from the beginning of the therapy in comparison with the control arm;Secondary Objective: To verify, as a result of the different treatment schemes with FSH, at 12 and 24 weeks of therapy and at the 36th week (follow-up), the following changes: 1. Increased plasma concentrations of FSH; 2. If at 12 weeks the subjects treated with 300 IU, 3 times a week have on average a Total Motile Sperm (TMS) higher than that of the subjects treated with a lower dosage (150 IU, 3 times a week) (subjects arm 3 vs arm 1, 2 and control); 3. At 24 weeks of treatment which of the 4 schemes has a better outcome in terms of average TMS increase and if this result is higher than the standard one; 4. After 12 weeks after the suspension of treatment, which of the 4 schemes shows an average of less decrease in TMS and which shows better performance than the standard scheme. 5. Improvement of other seminal parameters (such as morphology and viability).;Primary end point(s): To check if the new treatment schemes proposed in arms 1-3 are able to improve the number of spontaneous pregnancies and pregnancies obtained by medically assisted procreation techniques (PMA) within 36 weeks from the beginning of the therapy in comparison with the control arm;Timepoint(s) of evaluation of this end point: Within 36 weeks from the beginning of therapy

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Secondary

Measure	Time frame
Secondary end point(s): To check, as a result of the different treatment schemes with FSH, at 12 and 24 weeks of therapy and at the 36th week (follow-up), the following changes: 1. Increased plasma concentrations of FSH; ): To check, as a result of the different treatment schemes with FSH, at 12 and 24 weeks of therapy and at the 36th week (follow-up), the following changes 2. If at 12 weeks the subjects treated with 300 IU, 3 times a week have on average a Total Motile Sperm (TMS) higher than that of the subjects treated with a lower dosage (150 IU, 3 times a week) (subjects arm 3 vs arm 1, 2 and control); To check, as a result of the different treatment schemes with FSH, at 12 and 24 weeks of therapy and at the 36th week (follow-up), the following changes: 3. At 24 weeks of treatment which of the 4 schemes has a better outcome in terms of average TMS increase and if this result is higher than the standard one; To check, as a result of the different treatment schemes with FSH, at 12 and 24 weeks of therapy and at the 36th week (follow-up), the following changes: 4. After 12 weeks after the suspension of treatment, which of the 4 schemes shows an average of less decrease in TMS and which shows better performance than the standard scheme. ; To check, as a result of the different treatment schemes with FSH, at 12 and 24 weeks of therapy and at the 36th week (follow-up), the following changes: 5. Improvement of other seminal parameters (such as morphology and viability);Timepoint(s) of evaluation of this end point: 12, 24, 36 weeks; 12 weeks; 24 weeks; 12 weeks; 12, 24, 36 weeks	—

Measure

Time frame

Secondary end point(s): To check, as a result of the different treatment schemes with FSH, at 12 and 24 weeks of therapy and at the 36th week (follow-up), the following changes: 1. Increased plasma concentrations of FSH; ): To check, as a result of the different treatment schemes with FSH, at 12 and 24 weeks of therapy and at the 36th week (follow-up), the following changes 2. If at 12 weeks the subjects treated with 300 IU, 3 times a week have on average a Total Motile Sperm (TMS) higher than that of the subjects treated with a lower dosage (150 IU, 3 times a week) (subjects arm 3 vs arm 1, 2 and control); To check, as a result of the different treatment schemes with FSH, at 12 and 24 weeks of therapy and at the 36th week (follow-up), the following changes: 3. At 24 weeks of treatment which of the 4 schemes has a better outcome in terms of average TMS increase and if this result is higher than the standard one; To check, as a result of the different treatment schemes with FSH, at 12 and 24 weeks of therapy and at the 36th week (follow-up), the following changes: 4. After 12 weeks after the suspension of treatment, which of the 4 schemes shows an average of less decrease in TMS and which shows better performance than the standard scheme. ; To check, as a result of the different treatment schemes with FSH, at 12 and 24 weeks of therapy and at the 36th week (follow-up), the following changes: 5. Improvement of other seminal parameters (such as morphology and viability);Timepoint(s) of evaluation of this end point: 12, 24, 36 weeks; 12 weeks; 24 weeks; 12 weeks; 12, 24, 36 weeks

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Countries

Italy

Contacts

Public ContactUOC Andrologia e Medicina della Rip

Azienda Ospedaliera di Padova

andrea.garolla@unipd.it0498218518

Outcome results

None listed

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