Luteal Phase Support With Progesterone Versus Estrogen and Progesterone on Pregnancy Rates
NCT ID: NCT01237535
Last Updated: 2010-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
400 participants
INTERVENTIONAL
2011-11-30
2013-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Patients 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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Luteal support with progesterone only
Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel)Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived.
Luteal support with progesterone only
Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel).Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived.If no pregnancy will be achieved patients will undergo 3 treatment cycles preferably in the same treatment group.
Luteal support with estrogen + progesterone
Luteal support with estrogen + progesterone \[(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg\].
Luteal support with estrogen + progesterone
Luteal support with estrogen + progesterone \[(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg\].Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived.If no pregnancy will be achieved patients will undergo 3 treatment cycles preferably in the same treatment group.
No luteal support
Insemination without luteal support
Routine insemination procedure without luteal support
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Luteal support with progesterone only
Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel).Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived.If no pregnancy will be achieved patients will undergo 3 treatment cycles preferably in the same treatment group.
Luteal support with estrogen + progesterone
Luteal support with estrogen + progesterone \[(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg\].Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived.If no pregnancy will be achieved patients will undergo 3 treatment cycles preferably in the same treatment group.
Insemination without luteal support
Routine insemination procedure without luteal support
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. In their treatment cycle with ovarian stimulation and IUI using recombinant FSH in our institution.
Exclusion Criteria
* 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.
20 Years
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rabin Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rabin medical center
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Galia Oron, Dr
Role: PRINCIPAL_INVESTIGATOR
Rabin Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rabin Medical Center
Petah Tikva, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Galia Oron, Dr
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
rmc005788ctil
Identifier Type: -
Identifier Source: org_study_id