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Completed

NCT Number: NCT03115307

Luteal Phase Support in 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.

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Tampere University Hospital

Tampere, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triptorelin

Drug

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

Primary outcomes

  1. Live birth rate

    Time frame: At possible delivery (about 40 weeks)

Secondary outcomes

  1. Ongoing pregnancy rate

    Time frame: After two weeks

  2. Miscarriage rate

    Time frame: During subsequent about 40 weeks of pregnancy

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 14, 2017
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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