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

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03549741
Collaborator
(none)
120
2
16

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Clomiphene Citrate 50mg
  • Drug: Cabergoline Oral Tablet
  • Drug: Placebo Oral Tablet
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Cabergoline As An Adjuvant To Clomiphene Citrate For Management Of Unexplained Infertility: Randomized Controlled Trial
Anticipated Study Start Date :
Jul 1, 2018
Anticipated Primary Completion Date :
Jun 1, 2019
Anticipated Study Completion Date :
Nov 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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)

Drug: Clomiphene Citrate 50mg
oral tablets

Drug: Cabergoline Oral Tablet
oral tablets

Active Comparator: control group

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

Drug: Clomiphene Citrate 50mg
oral tablets

Drug: Placebo Oral Tablet
oral tablets

Outcome Measures

Primary Outcome Measures

  1. The number of mature follicles [14 days]

    the follicles reach the size of 18 mm

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Abdeltawab Mhanny, Principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT03549741
Other Study ID Numbers:
  • CabCC
First Posted:
Jun 8, 2018
Last Update Posted:
Jun 8, 2018
Last Verified:
May 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 8, 2018