Clinical Trial: Luteal Phase Support in Insemination Cycles

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Protocol for a Randomized, Controlled Study to Compare the Use of Gonodotropin-releasing Hormone Agonist Triptoreline (Gonapeptyl®) for Luteal Phase Support Versus Natural Luteal Phase in the I

Brief Summary: This study is a prospective randomized trial with 242 IUI cycles. Patients are randomized in two groups including 121 patients in each group. In the first group, the patients will be treated with triptoreline (Gonapeptyl®) in their luteal phase. As for the other group, the patients will undergo the luteal phase without any supportive medication. This study is going to clarify the role of the gonadotropin agonist (triptoreline, Gonapeptyl®) as a luteal phase supporter. The benefit of the treatment is measured by the numbers in the live birth and clinical pregnancy rates.

Detailed Summary:
Sponsor: Tampere University Hospital

Current Primary Outcome: Live birth rate [ Time Frame: At possible delivery (about 40 weeks) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Ongoing pregnancy rate [ Time Frame: After two weeks ]
  • Miscarriage rate [ Time Frame: During subsequent about 40 weeks of pregnancy ]


Original Secondary Outcome: Same as current

Information By: Tampere University Hospital

Dates:
Date Received: November 17, 2016
Date Started: January 2017
Date Completion: December 2021
Last Updated: April 10, 2017
Last Verified: November 2016