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Trial · Interventional

CompletedPhase 4Registry data

Luteal Phase Support in Insemination Cycles

NCTNCT03115307 (opens ClinicalTrials.gov in a new tab)Other idR16171MOther id2016-002321-11Other id2016
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Overview

Status
Completed
Phase
Phase 4
Enrollment
167 participants (actual)
Sponsor
Tampere University Hospital · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Finland

Start
Jan 2017
Primary completion
Nov 2019
Completion
Nov 2019
First posted
14 Apr 2017
Last update posted
27 Jan 2020
Conditions
Infertility, Female

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2017201820192020
  1. Ph 4

    Luteal Phase Support in Insemination Cycles

    NCT03115307

    Jan 2017 to Nov 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • TriptorelinDrug

Arms2

  • 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.

  • No intervention

    Control group

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Live birth rate

    Time frame · At possible delivery (about 40 weeks)

Secondary outcomes(2)

  1. Ongoing pregnancy rate

    Time frame · After two weeks

  2. Miscarriage rate

    Time frame · During subsequent about 40 weeks of pregnancy

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 43 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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