Luteal Phase Support in Insemination Cycles

Tampere University Hospital

Status and phase: Completed; Phase 4

Conditions: Infertility, Female

Treatments: Drug: Triptorelin

Study type: Interventional

Funder types: Other

Identifiers

NCT03115307

2016-002321-11 (EudraCT Number)

R16171M

Details and patient eligibility

About

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.

Enrollment: 167 patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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167 participants in 2 patient groups

Gonapeptyl

Experimental group

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.

Treatment:

Drug: Triptorelin

Control group

No Intervention group

Description:

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