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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-31

Study Completion Date

2019-11-30

Brief Summary

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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

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Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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study group

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)

Group Type EXPERIMENTAL

Clomiphene Citrate 50mg

Intervention Type DRUG

oral tablets

Cabergoline Oral Tablet

Intervention Type DRUG

oral tablets

control group

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

Group Type ACTIVE_COMPARATOR

Clomiphene Citrate 50mg

Intervention Type DRUG

oral tablets

Placebo Oral Tablet

Intervention Type DRUG

oral tablets

Interventions

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Clomiphene Citrate 50mg

oral tablets

Intervention Type DRUG

Cabergoline Oral Tablet

oral tablets

Intervention Type DRUG

Placebo Oral Tablet

oral tablets

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No