Comparing Luteal Stimulation and Estrogen Priming for IVF

Prospective, Randomized Trial Comparing Luteal Phase Ovarian Stimulation, and Luteal Estradiol Priming Protocol for Patients With Diminished Ovarian Reserve - The LUTEAL Trial

This study is testing two different ways to stimulate the ovaries in women with reduced egg supply to see which method helps them produce more eggs during IVF.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 142 (estimated)
• Ages: 20 Years to 45 Years
• Sex: Female
• Sponsor: Northwell Health (Academic / other)
• Locations: 1 site (Manhasset, New York)
• Trial ID: NCT04447872 on ClinicalTrials.gov

What this trial studies

This trial investigates two different ovarian stimulation protocols for women with diminished ovarian reserve (DOR) undergoing in vitro fertilization (IVF). Participants will be randomized to receive either luteal phase ovarian stimulation or estrogen priming, with the aim of determining which method yields a higher number of oocytes. The study will monitor participants' ovarian response through regular blood tests and ultrasounds during the stimulation process. The goal is to clarify the most effective approach for improving fertility outcomes in this population.

Who should consider this trial

Good fit: Ideal candidates are women aged 20-45 with regular menstrual cycles and a diagnosis of diminished ovarian reserve.

Not a fit: Patients who have undergone oocyte donation or freezing cycles, or those with current ovarian cysts or anovulatory conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance IVF success rates for women with diminished ovarian reserve.

How similar studies have performed: While there is ongoing debate regarding the best stimulation protocols for DOR, this approach is part of a broader exploration in the field and may provide new insights.

Eligibility criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Female aged 20 - 45
4. Regular menstrual cycles between 21 and 40 days
5. Presence of both ovaries
6. Meets criteria for DOR by the recent ASRM/ACOG Committee Opinion

   1. antimüllerian hormone (AMH) value less than 1 ng/mL
   2. antral follicle count less than 5-7 and
   3. follicle-stimulating hormone (FSH) greater than 10 IU/L or
   4. a history of poor response to in vitro fertilization stimulation (fewer than four oocytes at time of egg retrieval).

Exclusion Criteria:

1. Oocyte donation cycle
2. Oocyte freezing cycle
3. Current ovarian cyst \> 3cm
4. Anovulatory or oligo-ovulatory (\<6 ovulation per year)
5. Previous oophorectomy
6. Exposure to cytotoxic or pelvic irradiation
7. Planned aromatase inhibitor usage during current ovarian stimulation
8. Sensitizing or ovarian stimulating therapy in the past one month

   Additional contraindications to this study re, as follows (because such patients cannot receive an estrogen patch):
9. Undiagnosed abnormal genital bleeding
10. Known, suspected, or history of breast cancer
11. Known or suspected estrogen-dependent neoplasia
12. Active DVT, PE, or a history of these conditions
13. Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions
14. Known anaphylactic reaction or angioedema with estradiol patches
15. Known liver impairment or disease
16. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders

Where this trial is running

Manhasset, New York

• Northwell Fertility — Manhasset, New York, United States (Recruiting)

Study contacts

• Study coordinator: Baruch Abittan, MD

Conditions Infertility; Diminished Ovarian Reserve; IVF; In Vitro Fertilization; DOR; Controlled ovarian stimulation