Status:
UNKNOWN
The LUTEAL Trial: Luteal Stimulation vs. Estrogen Priming Protocol
Lead Sponsor:
Northwell Health
Conditions:
Infertility
Diminished Ovarian Reserve
Eligibility:
FEMALE
20-45 years
Phase:
NA
Brief Summary
Ovarian reserve defines the quantity and quality of the ovarian primordial follicular pool. Diminished ovarian reserve (DOR) indicates a reduction in the quantity of ovarian follicular pool to less th...
Detailed Description
Patients who will be undergoing controlled ovarian stimulation and who have a diagnosis of diminished ovarian reserve will be considered for this trial, and enrolled if meeting all inclusion and no ex...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Female aged 20 - 45
- Regular menstrual cycles between 21 and 40 days
- Presence of both ovaries
- Meets criteria for DOR by the recent ASRM/ACOG Committee Opinion
- antimüllerian hormone (AMH) value less than 1 ng/mL
- antral follicle count less than 5-7 and
- follicle-stimulating hormone (FSH) greater than 10 IU/L or
- a history of poor response to in vitro fertilization stimulation (fewer than four oocytes at time of egg retrieval).
Exclusion
- Oocyte donation cycle
- Oocyte freezing cycle
- Current ovarian cyst \> 3cm
- Anovulatory or oligo-ovulatory (\<6 ovulation per year)
- Previous oophorectomy
- Exposure to cytotoxic or pelvic irradiation
- Planned aromatase inhibitor usage during current ovarian stimulation
- 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):
- Undiagnosed abnormal genital bleeding
- Known, suspected, or history of breast cancer
- Known or suspected estrogen-dependent neoplasia
- Active DVT, PE, or a history of these conditions
- Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions
- Known anaphylactic reaction or angioedema with estradiol patches
- Known liver impairment or disease
- Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT04447872
Start Date
September 15 2020
End Date
June 1 2025
Last Update
October 16 2023
Active Locations (1)
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1
Northwell Fertility
Manhasset, New York, United States, 11030