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OpenTrials
Completed

NCT Number: NCT01826747

Intrauterine Insemination and Luteal Fase Support

The objective is to test the hypothesis that luteal phase support with vaginal progesterone leads to a higher clinical pregnancy rate (primary outcome) and live birth rate (secondary outcome) when compared to no luteal phase support in a program of intrauterine insemination (IUI) after controlled ovarian stimulation with gonadotrophins. Additionally, the length of the luteal phase will be recorded (secondary outcome) in order to detect luteal phase defects/insufficiencies in the absence of luteal phase suppletion as well as luteal phase prolongation in case of luteal phase support which may be a burden for the patients waiting for the outcome of the treatment.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

UZ Leuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients with an indication for IUI:

  • unexplained infertility
  • mild male factor infertility
  • minimal-mild endometriosis

Women:

  • first IUI cycle ever
  • normal ovulatory cycles (26-32d)
  • age<43,BMI≤30
  • presence of at least one patent tube on hysterosalpingography and/or laparoscopy
  • normal uterine cavity (ultrasound, hysterosalpingography, or laparoscopy)

Men: Total motile count ≥ 5 Million/ml after capacitation

Exclusion criteria

  • Patients with contra-indication for pregnancy , infertility or progesterone use.

Treatment and study plan

crinone (progesterone 8%, vaginal application)

Drug

Primary outcomes

  1. clinical pregnancy rate per IUI cycle

    Time frame: by ultrasound at ± 5 to 6 weeks after IUI

Secondary outcomes

  1. live birth rate per IUI cycle

    Time frame: 40 weeks after IUI

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Impact of Luteal Phase Support With Vaginal Progesterone on the Clinical Pregnancy Rate in Intrauterine Insemination Cycles Stimulated With Gonadotrophins: a Prospective Randomized Multicentre Study.

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Apr 8, 2013
Registry last updated
Oct 19, 2018

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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