Luteal Phase Support in Insemination Cycles

Sponsor

Tampere University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03115307

Collaborator

(none)

167

Enrollment

Location

Arms

Actual Duration (Months)

4.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female	Drug: Triptorelin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

167 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Nov 1, 2019

Actual Study Completion Date :

Nov 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gonapeptyl 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.	Drug: Triptorelin Triptorelin 0,1mg/ml subcutaneously once in a luteal phase in insemination cycles.
No Intervention: Control group In the control group, there are no luteal phase medications in the insemination cycle.

Arm

Intervention/Treatment

Experimental: Gonapeptyl

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.

Drug: Triptorelin

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

No Intervention: Control group

In the control group, there are no luteal phase medications in the insemination cycle.

Outcome Measures

Primary Outcome Measures

Live birth rate [At possible delivery (about 40 weeks)]

Secondary Outcome Measures

Ongoing pregnancy rate [After two weeks]
Miscarriage rate [During subsequent about 40 weeks of pregnancy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 43 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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