Luteal Phase Support With Progesterone vs Estrogen and Progesterone on Pregnancy Rates in Ovarian Stimulation and Intrauterine Insemination Cycles: a Prospective Randomized Study
Luteal support with progesterone only
+ Luteal support with estrogen + progesterone
+ Insemination without luteal support
Treatment Study
Summary
Study start date: November 1, 2011
Actual date on which the first participant was enrolled.Study design: single center, 3 arms, prospective randomized controlled open study Objective: to determine the impact of luteal phase support on pregnancy rates in ovarian stimulation and IUI cycles with recombinant FSH in patients with unexplained infertility and mild male factor. Methods: All patients in all study groups will undergo a single insemination procedure and then will be randomized into 3 groups: 1. Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel) 2. Luteal support with estrogen + progesterone \[(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg\]. 3. No luteal support Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived. A pregnancy test will be performed 2 weeks after insemination (Serum hCG) an intrauterine pregnancy will be confirmed using a transvaginal ultrasound 2 weeks after a positive pregnancy test. If no pregnancy will be achieved patients will undergo 3 treatment cycles preferably in the same treatment group.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.400 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.Any sex
Biological sex of participants that are eligible to enroll.From 20 to 40 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.Criteria
Inclusion Criteria: 1. Couples with diagnosis of unexplained infertility 2. In their treatment cycle with ovarian stimulation and IUI using recombinant FSH in our institution. Exclusion Criteria: 1. female partners with one or more of the following: * previous ovarian surgery * one ovary * polycystic ovaries on ultrasound examination * other endocrine abnormalities (i.e., polycystic ovarian syndrome, thyroid disorders,hyperprolactinemia,6.hypogonadotropic hypogonadism) * past ovarian hyperstimulation or hyperstimulation during the study period * diminished ovarian reserve (basal FSH level \>15 IU/mL) * age of \>40 years 2. sever male factor \< 5 million total motile sperm on the day of insemination.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
No InterventionStudy Objectives
Primary 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