Luteal Phase Support in Insemination Cycles

January 22, 2020 updated by: Tampere University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland
        • Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Live birth rate
Time Frame: At possible delivery (about 40 weeks)
At possible delivery (about 40 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Ongoing pregnancy rate
Time Frame: After two weeks
After two weeks
Miscarriage rate
Time Frame: During subsequent about 40 weeks of pregnancy
During subsequent about 40 weeks of pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Investigators

  • Principal Investigator: Helena Tinkanen, Tampere University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

November 17, 2016

First Submitted That Met QC Criteria

April 10, 2017

First Posted (Actual)

April 14, 2017

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R16171M
  • 2016-002321-11 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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