Luteal Phase Support in Insemination Cycles

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03115307

Enrollment

167

Registered

2017-04-14

Start date

2017-01-31

Completion date

2019-11-30

Last updated

2020-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Female

Keywords

Insemination, Luteal phase support, Gonadotropin-releasing hormone agonist, Triptorelin

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.

Interventions

DRUGTriptorelin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 43 Years

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

Design outcomes

Primary

Measure	Time frame
Live birth rate	At possible delivery (about 40 weeks)

Secondary

Measure	Time frame
Ongoing pregnancy rate	After two weeks
Miscarriage rate	During subsequent about 40 weeks of pregnancy

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026