Back to resultsLuteal Phase Support in Insemination Cycles
Primary Purpose
Infertility, Female
Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Triptorelin
Sponsored by
About this trial
This is an interventional treatment trial for Infertility, Female focused on measuring Insemination, Luteal phase support, Gonadotropin-releasing hormone agonist, Triptorelin
Eligibility Criteria
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
Sites / Locations
- Tampere University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Gonapeptyl
Control group
Arm Description
In the intervention group the patient will get the advice to using triptorelin (Gonapeptyl®) in the eight day after the injection of hCG (Pregnyl®) in the insemination cycle.
In the control group, there are no luteal phase medications in the insemination cycle.
Outcomes
Primary Outcome Measures
Live birth rate
Secondary Outcome Measures
Ongoing pregnancy rate
Miscarriage rate
Full Information
NCT ID
NCT03115307
First Posted
November 17, 2016
Last Updated
January 22, 2020
Sponsor
Tampere University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03115307
Brief Title
Luteal Phase Support in Insemination Cycles
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
November 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tampere University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
Keywords
Insemination, Luteal phase support, Gonadotropin-releasing hormone agonist, Triptorelin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
167 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gonapeptyl
Arm Type
Experimental
Arm Description
In the intervention group the patient will get the advice to using triptorelin (Gonapeptyl®) in the eight day after the injection of hCG (Pregnyl®) in the insemination cycle.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
In the control group, there are no luteal phase medications in the insemination cycle.
Intervention Type
Drug
Intervention Name(s)
Triptorelin
Intervention Description
Triptorelin 0,1mg/ml subcutaneously once in a luteal phase in insemination cycles.
Primary Outcome Measure Information:
Title
Live birth rate
Time Frame
At possible delivery (about 40 weeks)
Secondary Outcome Measure Information:
Title
Ongoing pregnancy rate
Time Frame
After two weeks
Title
Miscarriage rate
Time Frame
During subsequent about 40 weeks of pregnancy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helena Tinkanen
Organizational Affiliation
Tampere University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Luteal Phase Support in Insemination Cycles
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