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.
crinone (progesterone 8%, vaginal application)
Urogenital Diseases
+ Genital Diseases
+ Infertility
Treatment Study
Summary
Study start date: April 1, 2011
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.393 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 43 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
No InterventionStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location