Infertility, MalePhase 3NCT06564961
Clomiphene Citrate in Infertile Men With Idiopathic Oligoasthenozoospermia
A Phase 3 study testing Clomiphene Citrate in people with Infertility, Male, run by Shakeela Ishrat at 1 site in Bangladesh.
Trial summary
The goal of this clinical trial is to learn if drug clomiphene citrate improves sperm parameters in infertile men with idiopathic oligoasthenozoospermia. It will also learn about the safety of clomiphene citrate. Read more about this study
- Who is it for?
- Ages 25 to 45 years, men only
- Conditions the study is for
- Infertility, Male
- What is being tested?
- Clomiphene Citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jul 2022to 31 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Infertile men
- Idiopathic oligoasthenozoospermia (serum FSH and serum LH range was 2-7 IU/mL and serum testosterone level was >300 ng/dl)
Who cannot join
- Azoospermia
- Body mass index <18 kg/m2 and >30 kg/m2
- Any abnormality on genital examination and scrotal sonogram
- History of genital diseases \& genital surgery
- Medical and endocrine disorders like uncontrolled diabetes mellitus, severe kidney disease and liver insufficiency
- Psycho-sexual abnormalities
Show all 10Show fewer
- Antioxidant supplements in previous 3 months
- Smoking, drug, alcohol or substance abuse
- History of chemotherapy or radiotherapy
- Presence of any gross female factor abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Clomiphene Citrate on Sperm Parameters in Infertile Men With Idiopathic Oligoasthenozoospermia
The goal of this clinical trial is to learn if drug clomiphene citrate improves sperm parameters in infertile men with idiopathic oligoasthenozoospermia. It will also learn about the safety of clomiphene citrate. The main questions it aims to answer are:
- Does drug clomiphene citrate change sperm count and motility in infertile men with idiopathic oligoasthenozoospermia?
- What medical problems do participants have when taking drug clomiphene citrate? Researchers will compare drug clomiphene citrate to a placebo (a look-alike substance that contains no drug) to see if drug clomiphene citrate works to treat idiopathic oligoasthenozoospermia.
- Conditions
- Infertility, Male
- Being tested
- Clomiphene Citrate, Placebo
- Keywords
- Male infertility, Oligoasthenozoospermia, Testosterone, Clomiphene citrate
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clomiphene CitrateDrug
Also called Tab OVULET (Renata Pharmaceuticals Limited)
50 mg tab once daily
PlaceboDrug
Also called Placebo provided by Renata Pharmaceuticals Limited
1 tab once daily
| Study group | Role | What they receive |
|---|---|---|
| Clomiphene | Experimental | Participants will receive Tab Clomiphene citrate 50 mg orally once daily or 12 weeks Receives: Drug: Clomiphene Citrate |
| Placebo | Placebo comparator | Participants will receive Clomiphene citrate placebo tablet matching Clomiphene citrate orally once daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in sperm motility at 12 weeks
Sperm motility was percentage of progressive \& non-progressive motility
Measured: Baseline and 12 weeks
Change from baseline in sperm count at 12 weeks
Sperm count was in million per milliliter of semen
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start1 Jul 2022
- Primary completion30 Jun 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Infertility, MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shakeela Ishrat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shakeela Ishrat, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564961
- Sponsor's protocol ID
- 4068
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chehab M, Madala A, Trussell JC. On-label and off-label drugs used in the treatment of male infertility. Fertil Steril. 2015 Mar;103(3):595-604. doi: 10.1016/j.fertnstert.2014.12.122. Epub 2015 Feb 3.
PubMed 25660648Jung JH, Seo JT. Empirical medical therapy in idiopathic male infertility: Promise or panacea? Clin Exp Reprod Med. 2014 Sep;41(3):108-14. doi: 10.5653/cerm.2014.41.3.108. Epub 2014 Sep 30.
PubMed 25309854Cocuzza M, Agarwal A. Nonsurgical treatment of male infertility: specific and empiric therapy. Biologics. 2007 Sep;1(3):259-69.
PubMed 19707335Chua ME, Escusa KG, Luna S, Tapia LC, Dofitas B, Morales M. Revisiting oestrogen antagonists (clomiphene or tamoxifen) as medical empiric therapy for idiopathic male infertility: a meta-analysis. Andrology. 2013 Sep;1(5):749-57. doi: 10.1111/j.2047-2927.2013.00107.x.
PubMed 23970453Bridges N, Trofimenko V, Fields S, Carrell D, Aston K, Hotaling J. Male Factor Infertility and Clomiphene Citrate: A Meta-Analysis-The Effect of Clomiphene Citrate on Oligospermia. Urol Pract. 2015 Jul;2(4):199-205. doi: 10.1016/j.urpr.2014.10.007. Epub 2015 Apr 10.
PubMed 37559276Huijben M, Huijsmans RLN, Lock MTWT, de Kemp VF, de Kort LMO, van Breda JHMK. Clomiphene citrate for male infertility: A systematic review and meta-analysis. Andrology. 2023 Sep;11(6):987-996. doi: 10.1111/andr.13388. Epub 2023 Jan 29.
PubMed 36680549ElSheikh MG, Hosny MB, Elshenoufy A, Elghamrawi H, Fayad A, Abdelrahman S. Combination of vitamin E and clomiphene citrate in treating patients with idiopathic oligoasthenozoospermia: A prospective, randomized trial. Andrology. 2015 Sep;3(5):864-7. doi: 10.1111/andr.12086. Epub 2015 Jul 31.
PubMed 26235968
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Clomiphene Citrate on Sperm Parameters in Infertile Men With Idiopathic Oligoasthenozoospermia
- ClinicalTrials.gov ID
- NCT06564961
- Acronym / sponsor ID
- 4068
- Conditions
- Infertility, Male
- Keywords
- Male infertility, Oligoasthenozoospermia, Testosterone, Clomiphene citrate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Shakeela IshratUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if drug clomiphene citrate improves sperm parameters in infertile men with idiopathic oligoasthenozoospermia. It will also learn about the safety of clomiphene citrate. The main questions it aims to answer are:
- Does drug clomiphene citrate change sperm count and motility in infertile men with idiopathic oligoasthenozoospermia?
- What medical problems do participants have when taking drug clomiphene citrate? Researchers will compare drug clomiphene citrate to a placebo (a look-alike substance that contains no drug) to see if drug clomiphene citrate works to treat idiopathic oligoasthenozoospermia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clomiphene | Experimental | Drug: Clomiphene CitrateParticipants will receive Tab Clomiphene citrate 50 mg orally once daily or 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive Clomiphene citrate placebo tablet matching Clomiphene citrate orally once daily for 12 weeks |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Infertile men
- Idiopathic oligoasthenozoospermia (serum FSH and serum LH range was 2-7 IU/mL and serum testosterone level was >300 ng/dl)
Key exclusion criteria (10 listed)
- Azoospermia
- Body mass index <18 kg/m2 and >30 kg/m2
- Any abnormality on genital examination and scrotal sonogram
- History of genital diseases \& genital surgery
- Medical and endocrine disorders like uncontrolled diabetes mellitus, severe kidney disease and liver insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clomiphene CitrateAlso: Tab OVULET (Renata Pharmaceuticals Limited)50 mg tab once daily | Drug | Clomiphene |
| PlaceboAlso: Placebo provided by Renata Pharmaceuticals Limited1 tab once daily | Drug | Placebo |
Primary outcome
Change from baseline in sperm motility at 12 weeks
Time frame: Baseline and 12 weeks
Sperm motility was percentage of progressive \& non-progressive motility
Change from baseline in sperm count at 12 weeks
Time frame: Baseline and 12 weeks
Sperm count was in million per milliliter of semen
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Background: PubMed 25660648Chehab M, Madala A, Trussell JC. On-label and off-label drugs used in the treatment of male infertility. Fertil Steril. 2015 Mar;103(3):595-604. doi: 10.1016/j.fertnstert.2014.12.122. Epub 2015 Feb 3.
- Background: PubMed 25309854Jung JH, Seo JT. Empirical medical therapy in idiopathic male infertility: Promise or panacea? Clin Exp Reprod Med. 2014 Sep;41(3):108-14. doi: 10.5653/cerm.2014.41.3.108. Epub 2014 Sep 30.
- Background: PubMed 19707335Cocuzza M, Agarwal A. Nonsurgical treatment of male infertility: specific and empiric therapy. Biologics. 2007 Sep;1(3):259-69.
- Background: PubMed 23970453Chua ME, Escusa KG, Luna S, Tapia LC, Dofitas B, Morales M. Revisiting oestrogen antagonists (clomiphene or tamoxifen) as medical empiric therapy for idiopathic male infertility: a meta-analysis. Andrology. 2013 Sep;1(5):749-57. doi: 10.1111/j.2047-2927.2013.00107.x.
- Background: PubMed 37559276Bridges N, Trofimenko V, Fields S, Carrell D, Aston K, Hotaling J. Male Factor Infertility and Clomiphene Citrate: A Meta-Analysis-The Effect of Clomiphene Citrate on Oligospermia. Urol Pract. 2015 Jul;2(4):199-205. doi: 10.1016/j.urpr.2014.10.007. Epub 2015 Apr 10.
- Background: PubMed 36680549Huijben M, Huijsmans RLN, Lock MTWT, de Kemp VF, de Kort LMO, van Breda JHMK. Clomiphene citrate for male infertility: A systematic review and meta-analysis. Andrology. 2023 Sep;11(6):987-996. doi: 10.1111/andr.13388. Epub 2023 Jan 29.
- Results publication: PubMed 26235968ElSheikh MG, Hosny MB, Elshenoufy A, Elghamrawi H, Fayad A, Abdelrahman S. Combination of vitamin E and clomiphene citrate in treating patients with idiopathic oligoasthenozoospermia: A prospective, randomized trial. Andrology. 2015 Sep;3(5):864-7. doi: 10.1111/andr.12086. Epub 2015 Jul 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clomiphene Citrate in people with Infertility, Male, run by Shakeela Ishrat at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in sperm motility at 12 weeks (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06564961, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.