Luteal Phase Support in Insemination Cycles

NCT03115307 | Completed Phase 4 DMC

• 2 other identifiers: R16171M2016-002321-11
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility, Female

Keywords

Insemination; Luteal phase support; Gonadotropin-releasing hormone agonist; Triptorelin

Outcome Measures

Primary Outcomes (1)

• Live birth rate

  At possible delivery (about 40 weeks)

Secondary Outcomes (2)

• Ongoing pregnancy rate

  After two weeks

• Miscarriage rate

  During subsequent about 40 weeks of pregnancy

Study Arms (2)

Gonapeptyl

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Triptorelin DRUG

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

Gonapeptyl

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Tampere University Hospital

Tampere, Finland

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Helena Tinkanen

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: April 14, 2017
• Study Start: January 1, 2017
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: January 27, 2020

Record last verified: 2019-10

Locations

FI (1)