Luteal Phase Support in Insemination Cycles

Phase 4

Completed

• Conditions: Infertility, Female
• Interventions: Drug: Triptorelin

• Registration Number: NCT03115307
• Lead Sponsor: Tampere University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-17
• Study Start: 2017-01
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-14
• Status Verified: 2019-10
• Primary Completion: 2019-11
• Study Completion: 2019-11
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 167

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gonapeptyl	Triptorelin	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.

Primary Outcome Measures

Name	Time	Method
Live birth rate	At possible delivery (about 40 weeks)

Secondary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate	After two weeks
Miscarriage rate	During subsequent about 40 weeks of pregnancy

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland