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Hormone Therapy
Luteal Stimulation vs. Estrogen Priming for Diminished Ovarian Reserve
N/A
Recruiting
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presence of both ovaries
Female aged 20 - 45
Timeline
Screening 3 weeks
Treatment Varies
Follow Up when biopsy results return, usually within four weeks after oocyte retrieval
Awards & highlights
Study Summary
This trial will compare the two different protocols for controlled ovarian stimulation in patients with diminished ovarian reserve.
Who is the study for?
Women aged 20-45 with diminished ovarian reserve (DOR) who are undergoing in vitro fertilization can join this trial. They must have both ovaries, an AMH value less than 1 ng/mL, and a history of poor response to IVF stimulation or specific hormone levels indicating DOR. Participants need regular menstrual cycles and willingness to follow the study procedures.Check my eligibility
What is being tested?
The LUTEAL Trial is testing two different timing protocols for injectable gonadotropins in women with DOR: luteal stimulation versus estrogen priming protocol. The goal is to see which method yields more mature oocytes during controlled ovarian stimulation for assisted reproductive technologies.See study design
What are the potential side effects?
Injectable gonadotropins may cause side effects such as swelling at the injection site, abdominal pain or bloating, headache, mood swings, and rarely Ovarian Hyperstimulation Syndrome (OHSS), which includes symptoms like severe pelvic pain and shortness of breath.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have both of my ovaries.
Select...
I am a woman aged between 20 and 45.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ five to seven weeks post embryo transfer
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~five to seven weeks post embryo transfer
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of mature (Metaphase II) oocytes retrieved
Secondary outcome measures
Blastocyst development rate
Cycle cancellation rate
Duration of stimulation (days)
+3 moreOther outcome measures
Clinical pregnancy rate
Embryo ploidy status
Implantation rate
+1 moreTrial Design
2Treatment groups
Active Control
Group I: Luteal phase ovarian stimulation (LPOS)Active Control1 Intervention
Patients will present in the luteal phase, and will begin 150 IU hMG and 300 IU recombinant FSH daily, as well as oral Clomiphene citrate 100mg daily for the first five days of the stimulation. FSH can then be titrated per patient response. Gonadotropin releasing hormone antagonist (Ganirelix, Organon; and cetrorelix, Serono) will be started per criteria. Once patients are ready for ovulation trigger, 5-10,000 units of human chorionic gonadotropin, +/- GnRH agonist (i.e Luprolide acetate 40 IU), will be administered. All metaphase II oocytes obtained by oocyte retrieval will be fertilized with intracytoplasmic sperm injection (ICSI) or IVF. Embryos will be cultured to the blastocyst stage and vitrified on day 5-7 with or without embryo biopsy for genetic analysis.
Group II: Luteal estradiol priming protocolActive Control1 Intervention
In the luteal phase, the patient will begin Estradiol patches 0.1mg QOD. She will also take daily Gonadotropin releasing hormone (GnRH) antagonist (Ganirelix, Organon; and cetrorelix, Serono) for three days. With menses, she will begin 150 IU hMG, 300 IU recombinant FSH daily, and oral Clomiphene citrate 100mg qd (for five days). FSH can be titrated per patient response. GnRH antagonist will be started per criteria. 5-10,000 units of human chorionic gonadotropin, +/- GnRH agonist (i.e Luprolide acetate 40 IU) will be administered for ovulation trigger. All metaphase II oocytes obtained by oocyte retrieval will be fertilized with intracytoplasmic sperm injection (ICSI) or IVF. Embryos will be cultured to the blastocyst stage and vitrified on day 5-7 with or without embryo biopsy for genetic analysis.
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Who is running the clinical trial?
Northwell HealthLead Sponsor
458 Previous Clinical Trials
470,791 Total Patients Enrolled
3 Trials studying Infertility
465 Patients Enrolled for Infertility
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or had breast cancer.My cancer is thought to grow with estrogen.I have both of my ovaries.I have experienced unexplained bleeding from my genitals.I am a woman aged between 20 and 45.I have or had a blood clot in my legs or lungs.I have been exposed to strong radiation treatments in the pelvic area.I have not had hormone therapy for fertility in the last month.I have a liver condition.I will be using aromatase inhibitors for my current ovarian treatment.I have a known blood clotting disorder.I have had my ovaries surgically removed.I have had a stroke or heart attack, or currently have arterial thromboembolic disease.
Research Study Groups:
This trial has the following groups:- Group 1: Luteal phase ovarian stimulation (LPOS)
- Group 2: Luteal estradiol priming protocol
Awards:
This trial has 1 awards, including:- 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.
Infertility Patient Testimony for trial: Trial Name: NCT04447872 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical trial open to people aged 35 and younger?
"The necessary age range for these medical trials is 20 to 45 years old."
Answered by AI
Is there availability for participants in this research endeavor?
"Clinicaltrials.gov attests to this clinical trial's ongoing recruitment, which began on September 15th 2020 and was recently updated on the 29th of September 2022."
Answered by AI
Who is capable of participating in this clinical investigation?
"This study calls for 142 participants, all of whom are between 20 and 45 years old and have been diagnosed with infertility."
Answered by AI
What is the cap on participation for this research study?
"That is correct. According to clinicaltrials.gov, the initial post date for this trial was September 15th 2020 and it has been actively recruiting ever since then. A total of 142 participants are being sought out from 1 medical centre."
Answered by AI
Who else is applying?
What state do they live in?
Nevada
Florida
Other
New York
How old are they?
18 - 65
What site did they apply to?
Northwell Fertility
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0
2
What questions have other patients asked about this trial?
Can we use my spouses sperm? What is the procedure time like? When start the procedure! How many hours?
PatientReceived no prior treatments
Can people join a trial from other Countries?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
Trying to get pregnant soon :). No pregnancy in over a year and low AMH. I Have had 2 unsuccessful IVF procedures.
PatientReceived 1 prior treatment
I am hoping to do IVF but am not able to afford more than one cycle. Try need help with medications and IVF procedures! Find out about infertility situations!
PatientReceived no prior treatments
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