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GnRH Antagonist
Ganirelix vs Leuprolide for Embryo Implantation
N/A
Waitlist Available
Led By Maureen Kelly, MD
Research Sponsored by Kelly, Maureen, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Normal endometrial cavity
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-6 weeks
Awards & highlights
Study Summary
This trial compares two methods to prepare the uterine lining for implantation in egg donor cycles. The study method requires less time.
Who is the study for?
This trial is for individuals awaiting egg donation who have some ovarian function and a normal endometrial cavity. It's not suitable for those with large myomas, endometrial polyps, exposure to DES, very thin endometrium, active infections in the pelvic area or vulvovaginitis, hormonally sensitive cancers including breast cancer, severe cardiovascular diseases, diabetes with complications, liver disease including hepatic tumors or cholestatic disease, severe hypertension or neurologic headaches.Check my eligibility
What is being tested?
The study is comparing two methods of preparing the uterine lining for embryo implantation using donor eggs: one involving Ganirelix and another using Leuprolide. The new approach aims to reduce preparation time compared to standard practices while being equally effective.See study design
What are the potential side effects?
Potential side effects from Ganirelix may include allergic reactions and local skin reactions at the injection site. Leuprolide can cause symptoms like hot flashes, mood swings, headaches and vaginal dryness. Both drugs might affect menstrual cycles.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My endometrial cavity is normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
endometrial thickness measured by ultrasound
Secondary outcome measures
endometrial biopsy
Side effects data
From 2010 Phase 4 trial • 173 Patients • NCT0080236014%
Adnexa uteri pain
10%
Abdominal distension
7%
Nausea
7%
Abdominal pain lower
7%
Ovarian hyperstimulation syndrome
5%
Pharyngolaryngeal pain
5%
Back pain
5%
Breast tenderness
5%
Vaginal haemorrhage
2%
Fungal infection
2%
Bladder pain
2%
Acne
2%
Vomiting
2%
Abdominal discomfort
2%
Headache
2%
Dizziness
2%
Flatulence
2%
Depression
2%
Abdominal pain upper
2%
Procedural pain
2%
Constipation
2%
Irritability
2%
Vulvovaginal mycotic infection
2%
Procedural nausea
2%
Uterine spasm
2%
Dyspnoea
2%
Metrorrhagia
2%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Menopur/Endometrin
Menopur/Progesterone in Oil
Follistim/Endometrin
Follistim/Progesterone in Oil
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: GnRH antagonistExperimental Treatment1 Intervention
A GnRH antagonist will be used to suppress pituitary-ovarian function
Group II: GnRh agonistActive Control1 Intervention
This arm will use a GnRH agonist to suppress pituitary-ovarian function
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gonadorelin
FDA approved
Find a Location
Who is running the clinical trial?
Kelly, Maureen, M.D.Lead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,551 Total Patients Enrolled
Maureen Kelly, MDPrincipal InvestigatorSociety Hill Reproductive Medicine
3 Previous Clinical Trials
2,159 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My endometrial cavity is normal.My endometrial cavity is normal.I have not received treatment for vulvovaginitis.My ovaries are still functioning.I have a growth in my uterus known as an endometrial polyp.I have been exposed to DES.I have endometrial cancer or a cancer that is sensitive to hormones.I have breast cancer.I have heart or brain blood vessel disease.I have liver cancer or an active liver condition.I currently have an infection in my pelvic area.I have a history of blood clots.I experience headaches due to a brain or nerve condition.I have a liver condition that affects bile flow.I have been a heavy smoker and am over 35 years old.I have very high blood pressure.My ovaries are still functioning.You are currently waiting to receive an egg donation.I have fibroids larger than 4 cm.I have diabetes.I have a fibroid beneath the inner lining of my uterus.
Research Study Groups:
This trial has the following groups:- Group 1: GnRh agonist
- Group 2: GnRH antagonist
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Embryo Implantation Patient Testimony for trial: Trial Name: NCT01424618 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the participant capacity for this clinical trial?
"At this time, recruitment for this study has ceased. It was initially posted on January 1st 2006 and the last update was August 25th 2011. However, there are multiple other trials looking for volunteers; 3 studies focused around implantation, one relating to embryos and 107 related to Ganirelix currently require participants."
Answered by AI
Are there any precedents for using Ganirelix in a controlled environment?
"At the moment, 107 clinical studies related to Ganirelix are underway. Of those active trials, 33 have progressed to Phase 3. Whilst most of these research sites are situated in Duarte California, there is a total of 6567 locations running investigations into this drug's efficacy."
Answered by AI
Is it feasible for individuals who are older than twenty years to partake in this trial?
"The age range for this medical study is between 18 and 52. For younger patients, there are 8 trials underway while the elderly have access to 79 different clinical studies."
Answered by AI
Could I qualify to take part in this medical experiment?
"This research project is seeking 20 individuals with specific implantation and embryo age qualifications. Applicants must be expecting egg donor contributions, as well as display some ovarian function."
Answered by AI
What therapeutic purpose does Ganirelix serve?
"Ganirelix has been demonstrated to successfully address advanced prostate cancer, therapeutic procedures, and anemia."
Answered by AI
Is the recruitment period for this experiment still ongoing?
"As evidenced by the information on clinicaltrials.gov, this trial has halted recruitment of participants; it was initially posted in January 2006 and last updated August 2011. However, there are presently 110 other studies that require volunteers for their research projects."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Society Hill Reproductive Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I recently have an IVF in June 2023: 3 blastocysts transferred at D5, with no success. I am very much interested in sciences about this topic and am willing to do a lot to reach my goal.
PatientReceived 1 prior treatment
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