Luteal Phase Support in Insemination Cycles

NCT ID: NCT03115307

Last Updated: 2020-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

167 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-11-30

Brief Summary

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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

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Conditions

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Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Triptorelin

Intervention Type DRUG

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

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Triptorelin

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Helena Tinkanen

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

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Tampere University Hospital

Tampere, , Finland

Site Status

Countries

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Finland

Other Identifiers

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2016-002321-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R16171M

Identifier Type: -

Identifier Source: org_study_id

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