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

Assiut University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Infertility

Treatments: Drug: Cabergoline Oral Tablet; Drug: Placebo Oral Tablet; Drug: Clomiphene Citrate 50mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03549741

CabCC

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

study group

Experimental group

Description:

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)

Treatment:

Drug: Clomiphene Citrate 50mg

Drug: Cabergoline Oral Tablet

control group

Active Comparator group

Description:

will receive a dose of Clomiphene citrate and placebo tablets with same dose and duration

Treatment:

Drug: Clomiphene Citrate 50mg

Drug: Placebo Oral Tablet