Cabergoline As An Adjuvant To Clomiphene Citrate For Management Of Unexplained Infertility

Phase 2

• Conditions: Infertility
• Interventions: Drug: Clomiphene Citrate 50mg; Drug: Placebo Oral Tablet; Drug: Cabergoline Oral Tablet

• Registration Number: NCT03549741
• Lead Sponsor: Assiut University

Brief 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. In many countries infertility refers to a couple that has failed to conceive after 12 months of regular sexual intercourse

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-05
• Study First Submitted: 2018-05-26
• Study First Submitted QC: 2018-05-26
• Last Update Submitted: 2018-05-26
• Study First Posted: 2018-06-08
• Last Update Posted: 2018-06-08
• Study Start: 2018-07
• Primary Completion: 2019-06
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• unexplained infertility, Primary or secondary.
• Absence of galactorrhoea.
• Normal serum prolactin.
• Normal hysterosalpingography.
• Normal spermogram.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	Clomiphene Citrate 50mg	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)
control group	Placebo Oral Tablet	will receive a dose of Clomiphene citrate and placebo tablets with same dose and duration
study group	Cabergoline Oral Tablet	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)
control group	Clomiphene Citrate 50mg	will receive a dose of Clomiphene citrate and placebo tablets with same dose and duration

Primary Outcome Measures

Name	Time	Method
The number of mature follicles	14 days	the follicles reach the size of 18 mm