← Back to Search

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
Must not have
Known, suspected, or history of breast cancer
Known or suspected estrogen-dependent neoplasia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up when biopsy results return, usually within four weeks after oocyte retrieval
Awards & highlights

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 below
Select...
I have both of my ovaries.
Select...
I am a woman aged between 20 and 45.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have or had breast cancer.
Select...
My cancer is thought to grow with estrogen.
Select...
I have experienced unexplained bleeding from my genitals.
Select...
I have or had a blood clot in my legs or lungs.
Select...
I have been exposed to strong radiation treatments in the pelvic area.
Select...
I have a liver condition.
Select...
I will be using aromatase inhibitors for my current ovarian treatment.
Select...
I have a known blood clotting disorder.
Select...
I have had my ovaries surgically removed.
Select...
I have had a stroke or heart attack, or currently have arterial thromboembolic disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two weeks post embryo transfer
This trial's timeline: 3 weeks for screening, Varies for treatment, and two weeks post embryo transfer for reporting.

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 more
Other outcome measures
Clinical pregnancy rate
Embryo ploidy status
Implantation rate
+1 more

Trial Design

2Treatment groups
Active Control
Group I: 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.
Group II: 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.

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
461 Previous Clinical Trials
470,993 Total Patients Enrolled
3 Trials studying Infertility
465 Patients Enrolled for Infertility

Media Library

Estradiol Priming Protocol (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04447872 — N/A
Infertility Research Study Groups: Luteal estradiol priming protocol, Luteal phase ovarian stimulation (LPOS)
Infertility Clinical Trial 2023: Estradiol Priming Protocol Highlights & Side Effects. Trial Name: NCT04447872 — N/A
Estradiol Priming Protocol (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04447872 — N/A
Infertility Patient Testimony for trial: Trial Name: NCT04447872 — N/A
~25 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top