A Phase 3 interventional study of Bravelle in Male Infertility, sponsored by Instituto de Investigacion Sanitaria La Fe. Terminated at 1 site in Spain. Open to male participants aged 25 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-02.
Sponsored by Instituto de Investigacion Sanitaria La Fe · Phase 3, Interventional, and Treatment
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Among 17 studies in Infertility, Male with a site in Spain — 7 open to participants now, 7 under way, 1 of them phase 3. Infertility, Male · Spain.
Among the 17 studies in Infertility, Male with a site in Spain, this one is the 9th largest by enrollment of the 10 interventional ones that give a count, is the only one that started in 2015, is the only one in phase 3, and was the 2nd registered.
282 studies on the registry are indexed under Infertility, Male; 65 are open to participants now.
Browse Infertility, Male studies →7 of the 17 studies in Infertility, Male with a site in Spain are open now. Recruiting first, the newest first:
Fecundis Lab SL · Sites in Spain
Ages 18–60
Ginefiv · Sites in Spain
Ages 18–45 · Men only
Prokrea BCN, S.L. · Sites in Spain
Ages 18–38
Fecundis Lab SL · Sites in Spain
Ages 18–60 · Men only · Healthy volunteers
Fitoplancton Marino, S.L. · Sites in Spain
Ages 18–45 · Men only
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 40 Infertility, Male studies recruiting now, 16 (40%) set no upper age limit and 24 (60%) stop at 75 or younger; 7 take children under 18; 14 take healthy volunteers.
This study: 25 Years to 45 Years · male · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 2 · Phase 3 2
First in 2006; this study’s year is marked. 1 started in 2015.
This study's enrollment of 30 is below the median of 80 across 187 interventional studies indexed under Infertility, Male.
Median enrollment 70 across the 10 interventional studies, 100 across the 7 observational. Of the 8 that completed or were terminated, 1 (13%) have results posted.
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4 of 17 have an industry lead sponsor. The 10 most frequent:
Instituto de Investigacion Sanitaria La Fe is the lead sponsor of 59 studies on the registry; 13 are open to participants now.
Instituto de Investigacion Sanitaria La Fe has 1 study filed under Infertility, Male — fewer than ten, so there is no comparison to draw.
2 of the studies in Infertility, Male with a site in Spain that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07669584Phase 3Prokrea BCN, S.L.PKB171 Against Placebo in Couples With Mild Male Factor Infertility | 2027-10-28 |
| NCT07185984Instituto Valenciano de Infertilidad, IVI VALENCIAFunctional Development and Clinical Validation of a Diagnostic Tool Based on Artificial Intelligence for the Assessment of Sperm Quality and the Selection of the Optimal In Vitro Fertilisation (IVF) Treatment | 2027-11 |
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Among the 17 studies in Infertility, Male with a site in Spain, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Single center, prospective, open clinical study to determine the genomic imprint (epigenetic modification) in a series of male infertility patients with alterations in their spermiogram (oligozoospermia) compared to a group of fertile patients in order to evaluate the effect of FSH ( follicle stimulating hormone) administration on these modifications and on male infertility.
Single center, prospective, open clinical study to determine the genomic imprint (epigenetic modification) in a series of male infertility patients with alterations in their spermiogram (oligozoospermia) compared to a group of fertile patients in order to evaluate the effect of FSH ( follicle stimulating hormone) administration on these modifications and on male infertility.
Main objective: To determine the genomic imprint (epigenetic modification) in a series of male infertility patients with alterations in their spermiogram (oligozoospermia) compared to a group of fertile patients in order to evaluate the effect of FSH administration on these modifications and on male infertility.
Secondary objectives
Inclusion criteria for the infertility treatment group (n=30)
Inclusion criteria for the control group of fertile males (n=15)
Exclusion criteria for the infertility treatment group.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients referred will be evaluated to participate in the study and then asked to take part.In this visit,the normal protocol for infertility patients will be followed and at least 2 spermiograms and a blood test analyzing the following parameters:FSH, LH,Estradiol,Total testosterone,SHBG, Albumin,Calculation of bioavailable testosterone,Prolactin.If these tests have not been performed,a second baseline visit will be scheduled.Should the patient meet all the inclusion criteria and after the patient has signed an informed consent form agreeing to participate in the study,the physician will prescribe the medication and schedule visits.Before initiating the treatment, they will provide a semen sample.This sample will be sent to the Center for Reproductive Biology,where the sample will be subjected to epigenetic analysis.The patient will be given samples of Bravelle.It is administered subcutaneously.The dose will be 150 IU 3times a week for 3months
Drug: Bravelle
Patients who volunteer will be informed of the nature of the study and asked to sign the informed consent form. At least two spermiograms will be performed along with a blood test analyzing the following parameters:FSH,LH,Estradiol,Total testosterone,SHBG,Albumin,Estimation of bioavailable testosterone,Prolactin. A second baseline visit will be scheduled to evaluate the test results and to check whether these subjects meet all the inclusion criteria for the control group. Those subjects will provide a semen sample which will be stored at -20º C. Outpatient visit: week twelve: a physical exam will be carried out to identify any adverse reactions. A blood test and a semen sample will also be obtained.
Bravelle will be provided to all patients in the treatment group by the principal investigator (PI) or another member of the research team. From week nine on, the patients will undergo a physical examination on three different occasions to assess the appearance of any adverse reactions during treatment. It will be up to the patient to communicate the appearance of signs or symptoms which could be associated with the use of the drug. At week 12 the patient will be scheduled for another visit to perform a semen study and to measure new hormone levels. To this end, a blood test will be carried out (FSH, LH, estradiol, total testosterone, SHBG, and albumin to calculate the amount of bioavailable testosterone). A semen sample will also be obtained to carry out a spermiogram according to WHO guidelines; part of this sample will be used for epigenetic analysis.
Epigenetic modification
To determine the genomic imprint (epigenetic modification) in a series of male infertility patients with alterations in their spermiogram (oligozoospermia) compared to a group of fertile patients in order to evaluate the effect of FSH administration on these modifications and on male infertility
Time frame: 12 weeks after treatment.
To assess the main characteristics of the spermiograms of infertility patients before and after FSH treatment.
To assess the main characteristics of the spermiograms of infertility patients before and after FSH treatment.
Time frame: First week and end of treatment visit (12 weeks).
To assess modifications in the hormones involved in sperm formation in infertility patients before and after treatment.
To assess modifications in the hormones involved in sperm formation in infertility patients before and after treatment.
Time frame: First week and end of treatment visit (12 weeks)
Pregnancy rate.
To analyze the results of assisted reproduction treatments in patients receiving FSH treatment.
Time frame: 6-7 weeks after transfer of the embryo.
The record gives a start of Nov 2015, a primary completion of Jun 2017 and a completion of Jun 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Urofollitropin
Instituto de Investigacion Sanitaria La Fe