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Luteal Phase Support in Insemination Cycles

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ClinicalTrials.gov Identifier: NCT03115307
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
Tampere University Hospital

Brief Summary:
This study is a prospective randomized trial with 242 IUI cycles. Patients are randomized in two groups including 121 patients in each group. In the first group, the patients will be treated with triptoreline (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 (triptoreline, Gonapeptyl®) as a luteal phase supporter. The benefit of the treatment is measured by the numbers in the live birth and clinical pregnancy rates.

Condition or disease Intervention/treatment Phase
Infertility, Female Drug: Triptorelin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Gonapeptyl
In the intervention group the patient will get the advice to using triptoreline (Gonapeptyl®) in the eight day after the injection of hCG (Pregnyl®) in the insemination cycle.
Drug: Triptorelin
Triptoreline 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.



Primary Outcome Measures :
  1. Live birth rate [ Time Frame: At possible delivery (about 40 weeks) ]

Secondary Outcome Measures :
  1. Ongoing pregnancy rate [ Time Frame: After two weeks ]
  2. Miscarriage rate [ Time Frame: During subsequent about 40 weeks of pregnancy ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115307


Contacts
Contact: Helena Tinkanen helena.tinkanen@pshp.fi
Contact: Riikka Leppänen riikka.leppanen@pshp.gi

Locations
Finland
Tampere University Hospital Recruiting
Tampere, Finland
Contact: Helena Tinkanen, M.D., Ph.D.         
Contact: Riikka Leppänen, M.D.         
Sponsors and Collaborators
Tampere University Hospital
Investigators
Principal Investigator: Helena Tinkanen Tampere University Hospital

Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT03115307     History of Changes
Other Study ID Numbers: R16171M
2016-002321-11 ( EudraCT Number )
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: November 2016

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tampere University Hospital:
Insemination
Luteal phase support
Gonadotropin-releasing hormone agonist
Triptoreline

Additional relevant MeSH terms:
Infertility, Female
Infertility
Genital Diseases, Male
Genital Diseases, Female
Triptorelin Pamoate
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents