InfertilityPhase 2/3NCT03549741
Cabergoline As An Adjuvant To Clomiphene Citrate For Management Of Unexplained Infertility
A Phase 2/3 study testing Clomiphene Citrate 50mg and Cabergoline Oral Tablet in people with Infertility, run by Assiut University.
Trial summary
Infertility refers to an inability to conceive after having regular unprotected sex. Infertility can also refer to the biological inability of an individual to contribute to conception, or to a female who cannot carry a pregnancy to full term. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Clomiphene Citrate 50mg and Cabergoline Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jul 2018to Nov 2019
- Phase
- Phase 2/3
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- unexplained infertility, Primary or secondary.
- Absence of galactorrhoea.
- Normal serum prolactin.
- Normal hysterosalpingography.
- Normal spermogram.
Who cannot join
- Women on other line of treatment as aromatase inhibitors,gonadotrophins, or tamoxifen.
- Known hypersensitivity for cabergoline or clomiphene citrate.
- Other factors of infertility as tubal factor, uterine factor or male factor.
About this study
Official title: Cabergoline As An Adjuvant To Clomiphene Citrate For Management Of Unexplained Infertility: Randomized Controlled Trial
Infertility refers to an inability to conceive after having regular unprotected sex. Infertility can also refer to the biological inability of an individual to contribute to conception, or to a female who cannot carry a pregnancy to full term. In many countries infertility refers to a couple that has failed to conceive after 12 months of regular sexual intercourse
- Conditions
- Infertility
- Being tested
- Clomiphene Citrate 50mg, Cabergoline Oral Tablet, Placebo Oral Tablet
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clomiphene Citrate 50mgDrug
oral tablets
Cabergoline Oral TabletDrug
oral tablets
Placebo Oral TabletDrug
oral tablets
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | will receive a dose of Clomiphene citrate 50 mg tablet , 1 tab twice daily for 5 days from the third day of menses to the seven day and cabergoline 0.25 mg (half tablet) every 3 days (one package) first three months then Clomiphene citrate 50 mg tablet , 2 tabs twice daily for 5 days from the third day of menses to the seven day and cabergoline 0.25 mg (half tablet) every 3 days (one package) Receives: Drug: Clomiphene Citrate 50mg; Drug: Cabergoline Oral Tablet |
| control group | Active comparator | will receive a dose of Clomiphene citrate and placebo tablets with same dose and duration Receives: Drug: Clomiphene Citrate 50mg; Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of mature follicles
the follicles reach the size of 18 mm
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study startJul 2018 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdeltawab Mhanny, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549741
- Sponsor's protocol ID
- CabCC
- Status last verified
- May 2018
- First submitted
- 26 May 2018
- Last updated
- 8 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cabergoline As An Adjuvant To Clomiphene Citrate For Management Of Unexplained Infertility: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03549741
- Acronym / sponsor ID
- CabCC
- Conditions
- Infertility
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 8 Jun 2018 (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.
Infertility refers to an inability to conceive after having regular unprotected sex. Infertility can also refer to the biological inability of an individual to contribute to conception, or to a female who cannot carry a pregnancy to full term. In many countries infertility refers to a couple that has failed to conceive after 12 months of regular sexual intercourse
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: Clomiphene Citrate 50mg, Drug: Cabergoline Oral Tabletwill receive a dose of Clomiphene citrate 50 mg tablet , 1 tab twice daily for 5 days from the third day of menses to the seven day and cabergoline 0.25 mg (half tablet) every 3 days (one package) first three months then Clomiphene citrate 50 mg tablet , 2 tabs twice daily for 5 days from the third day of menses to the seven day and cabergoline 0.25 mg (half tablet) every 3 days (one package) |
| control group | Active comparator | Drug: Clomiphene Citrate 50mg, Drug: Placebo Oral Tabletwill receive a dose of Clomiphene citrate and placebo tablets with same dose and duration |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- unexplained infertility, Primary or secondary.
- Absence of galactorrhoea.
- Normal serum prolactin.
- Normal hysterosalpingography.
- Normal spermogram.
Key exclusion criteria (3 listed)
- Women on other line of treatment as aromatase inhibitors,gonadotrophins, or tamoxifen.
- Known hypersensitivity for cabergoline or clomiphene citrate.
- Other factors of infertility as tubal factor, uterine factor or male factor.
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 Citrate 50mgoral tablets | Drug | control group, study group |
| Cabergoline Oral Tabletoral tablets | Drug | study group |
| Placebo Oral Tabletoral tablets | Drug | control group |
Primary outcome
The number of mature follicles
Time frame: 14 days
the follicles reach the size of 18 mm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Clomiphene Citrate 50mg and Cabergoline Oral Tablet in people with Infertility, run by Assiut University.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
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?
The number of mature follicles (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2018.