RECRUITING

The LUTEAL Trial: Luteal Stimulation vs. Estrogen Priming Protocol

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-09-15
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04447872

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:20 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provision of signed and dated informed consent form
  2. 2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. 3. Female aged 20 - 45
  4. 4. Regular menstrual cycles between 21 and 40 days
  5. 5. Presence of both ovaries
  6. 6. Meets criteria for DOR by the recent ASRM/ACOG Committee Opinion
  7. 1. antimüllerian hormone (AMH) value less than 1 ng/mL
  8. 2. antral follicle count less than 5-7 and
  9. 3. follicle-stimulating hormone (FSH) greater than 10 IU/L or
  10. 4. a history of poor response to in vitro fertilization stimulation (fewer than four oocytes at time of egg retrieval).
  1. 1. Oocyte donation cycle
  2. 2. Oocyte freezing cycle
  3. 3. Current ovarian cyst \> 3cm
  4. 4. Anovulatory or oligo-ovulatory (\<6 ovulation per year)
  5. 5. Previous oophorectomy
  6. 6. Exposure to cytotoxic or pelvic irradiation
  7. 7. Planned aromatase inhibitor usage during current ovarian stimulation
  8. 8. Sensitizing or ovarian stimulating therapy in the past one month
  9. 9. Undiagnosed abnormal genital bleeding
  10. 10. Known, suspected, or history of breast cancer
  11. 11. Known or suspected estrogen-dependent neoplasia
  12. 12. Active DVT, PE, or a history of these conditions
  13. 13. Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions
  14. 14. Known anaphylactic reaction or angioedema with estradiol patches
  15. 15. Known liver impairment or disease
  16. 16. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders

Contacts and Locations

Study Contact

Baruch Abittan, MD
CONTACT
5165621735
babittan2@northwell.edu

Study Locations (Sites)

Northwell Fertility
Manhasset, New York, 11030
United States

Collaborators and Investigators

Sponsor: Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-15
Study Completion Date2025-06

Study Record Updates

Study Start Date2020-09-15
Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

  • IVF
  • In Vitro Fertilization
  • DOR
  • Diminished Ovarian Reserve
  • Controlled ovarian stimulation

Additional Relevant MeSH Terms

  • Infertility
  • Diminished Ovarian Reserve
  • IVF