The LUTEAL Trial: Luteal Stimulation vs. Estrogen Priming Protocol
Status unconfirmed · Not applicable
Conditions studied: Infertility, Diminished Ovarian Reserve, IVF
In brief
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 than expected for age. It is an important cause of infertility in many couples. To date, there is no clear consensus in the literature on the definition of diminished ovarian reserve, and it is unclear whether low oocyte yield results from an abnormal atresia rate of the follicle pool, or from a lower follicle pool at birth or whether it can just occur as a normal variation in the population. The ovarian response to controlled ovarian stimulation with gonadotropins (for example, for in vitro fertilization) is largely determined by the ovarian reserve, and there are numerous different ovarian stimulation protocols that are employed to try and increase the oocyte yield of a particular cycle. There is no consensus on which, if any, of these protocols are superior and preferred for patient with DOR. Luteal gonadotropin stimulation is a protocol of controlled ovarian stimulation (COS) for use in assisted reproductive technologies (ART) that has emerged over the past decade as an acceptable alternative to the classic follicular gonadotropin stimulation. The luteal estradiol patch protocol was introduced in 2005 in patients with poor response to controlled ovarian stimulation (COS) and to address the phenomenon of early follicle recruitment in patients with diminished ovarian reserve (DOR). Luteal gonadotropin stimulation can potentially achieve the same effect by initiating follicular recruitment for IVF prior to the body's own premature recruitment. Our hypothesis is that the luteal stimulation protocol and estradiol priming protocol are equivalent with regard to the outcome of number of mature oocytes retrieved. 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 exclusion criteria.
Key facts
- Study ID
- NCT04447872
- Run by
- Northwell Health
- People needed
- 142
- Starts
- 2020-09-15
- Expected to finish
- 2025-06-01
- Last updated by the study team
- 2023-10-16
Who can join
Age: 20 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
Where it is running
- Northwell Fertility — Manhasset, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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