Single Injection of Ganirelix in Gonadotropin Intrauterine Insemination (IUI) Cycles
NCT ID: NCT01286051
Last Updated: 2013-03-20
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.
COMPLETED
NA
80 participants
INTERVENTIONAL
2011-01-31
2012-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Premature Luteinization Prevention by GnRH Antagonist in Patients Undergoing IUI
NCT00780858
Early Follicular Supplementation of Ganirelix in IVF 2004
NCT00461422
To Compare the Efficacy and Safety of Oral SHR 7280 Tablets With Ganirelix Acetate Injection in Infertile Female Subjects
NCT05994378
Usefulness of Medroxyprogesterone Acetate in Follicular Phase in Oocyte Donors. Undergoing Ovarian Stimulation
NCT03300960
Gonadotrophin Releasing Hormone Agonist Addition for Luteal Support in In-vitro Fertilization and Embryo Transfer Cycles
NCT02908438
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Protocol A (control group): On menstrual cycle day 3, the patient will start gonadotropins (Follistim) injections at a starting dose of 75-150 IU and monitored according to the discretion of the treating physician. When the leading follicle reaches a size of at least 18mm, intramuscular human chorionic gonadotripin (hCG) (10,000 IU) is administered, followed by two inseminations, one at 12 hours after hCG, and the other at 36 hours. All patients will have luteal support using progesterone vaginal suppositories at a dose of 200mg two times per day (BID). Pregnancy testing will be scheduled at 2 weeks after the IUI. The treatment cycle typically lasts from 8-13 days, depending on the patient's response.
Protocol B (study group): On menstrual cycle day 3, the patient will start gonadotropins (Follistim) injections at a starting dose of 75-150 IU and monitored according to the discretion of the treating physician. When the leading follicle reaches a size of 13-14mm in mean diameter, or when the estradiol level reaches a level of 400 pg/ml, ganirelix injection at the standard dose of 250mcg is given once subcutaneously. When the leading follicle reaches a size of at least 18mm, intramuscular hCG (10,000IU) is administered followed by two inseminations, one at 12 hours after hCG, and the other at 36 hours. All patients will have luteal support using progesterone suppositories at a dose of 200mg BID. Pregnancy testing will be scheduled at 2 weeks after the IUI. The treatment cycle typically lasts from 8-13 days, depending on the patient's response.
Patients will be randomized, via computer generated program, in a 1:1 fashion.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
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.
Follistim
standard treatment
Follistim administration
adminstation of FSH for ovulation induction
Follistim plus single ganirelix injection
Follistim plus Ganirelix
Follistim plus single injection of ganirelix
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Follistim administration
adminstation of FSH for ovulation induction
Follistim plus Ganirelix
Follistim plus single injection of ganirelix
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* One or more of the following infertility diagnoses: ovulation dysfunction, mild male factor infertility (sperm concentration of 5- 20 million/ml, and/or sperm motility 10% - 40%) , absence teratospermia (i.e. strict morphology \> 4%), unexplained infertility.
* Patent Fallopian tubes.
* Normal uterine structure (i.e. absence of mullerian anomalies)
* Ability to consent to the study.
* Patients should be Houston Fertility Institute patients
Exclusion Criteria
* Severe male factor (concentration \< 10 million/ml or strict morphology \< 4%)
* Obstructed Fallopian tubes on one or both sides
* Stage III or IV endometriosis
* Elevated FSH level (\>10 IU/L)
* Low antral follicular count (\< 4 antral follicles per ovary)
* Any other contraindication for ovulation induction
* Inability to consent to the study
* History of any prior failed OI/IUI cycle
18 Years
39 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Houston Fertility Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ghassan F. Haddad
Medical Director
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ghassan F Haddad, M.D.
Role: PRINCIPAL_INVESTIGATOR
Houston Fertility Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Houston Fertility Institute
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
practice website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P08115
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.