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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

Must not have

Known, suspected, or history of breast cancer

Known or suspected estrogen-dependent neoplasia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first day after oocyte retrieval

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I have both of my ovaries.

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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:

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I have or had breast cancer.

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My cancer is thought to grow with estrogen.

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I have experienced unexplained bleeding from my genitals.

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I have or had a blood clot in my legs or lungs.

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I have been exposed to strong radiation treatments in the pelvic area.

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I have a liver condition.

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I will be using aromatase inhibitors for my current ovarian treatment.

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I have a known blood clotting disorder.

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I have had my ovaries surgically removed.

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I have had a stroke or heart attack, or currently have arterial thromboembolic disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first day after oocyte retrieval

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first day after oocyte retrieval

This trial's timeline: 3 weeks for screening, Varies for treatment, and first day after oocyte retrieval for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of mature (Metaphase II) oocytes retrieved

Secondary study objectives

Blastocyst development rate

Cycle cancellation rate

Duration of stimulation (days)

+3 more

Other study objectives

Clinical pregnancy rate

Embryo ploidy status

Implantation rate

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 12Eligibility criteria met