Luteal Phase Support in Insemination Cycles

Infertility, Female Clinical Trial

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 Insemination Cycles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03115307
• Other study ID #: R16171M
• Secondary ID: 2016-002321-11
• Status: Completed
• Phase: Phase 4
• Start date: January 2017
• Est. completion date: November 2019

Study information

• Verified date: October 2019
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a prospective randomized trial with 242 IUI cycles. Patients are randomized in two groups including 121 cycles in each group. A total of 255 cycles in 167 patients are finally recruited. In the first group, the patients will be treated with triptorelin (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 (triptorelin acetate, Gonapeptyl®) as a luteal phase supporter. The benefit of the treatment is measured by the numbers in the live birth and clinical pregnancy rates.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

Inclusion Criteria:

• - Patients with ovarian stimulation cycles preparing to insemination

• Patients with medical ovarian stimulation protocols including GnRH agonist, aromatase inhibitors and different combinations of GnRH agonists and aromatase inhibitors are included

• Patient's willingness to participate in the study

Exclusion Criteria:

• - Failure in the ovarian stimulation cycle

• Failures in executing the insemination

• Failures in giving the sperm sample

• Major troubles in sperm parameters leading to an inadequate sample to accomplish intrauterine insemination

• Patients with primarily planned progesterone luteal support

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Drug:
• Triptorelin
Triptorelin 0,1mg/ml subcutaneously once in a luteal phase in insemination cycles.

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rate		At possible delivery (about 40 weeks)
Secondary	Ongoing pregnancy rate		After two weeks
Secondary	Miscarriage rate		During subsequent about 40 weeks of pregnancy