Search / Trial NCT06227949

FSH and LH Versus FSH Alone for Ovarian Stimulation in Non-hormone Sensitive Onco-fertility Patients

Launched by ELLEN GREENBLATT · Jan 18, 2024

Trial Information

Current as of October 07, 2024

Not yet recruiting

Keywords

Ivf Fertility Preservation Oncofertility R Lh Fsh Cryopreservation

Description

The proposed study is a superiority, randomized controlled trial examining the effect of FSH and rLH (Luveris) versus FSH alone on the number of mature oocytes available for cryopreservation in non-hormone sensitive onco-fertility patients. These patients include those diagnosed with malignancy other than breast, uterine and ovarian cancer. Given that the care of oncology patients is time sensitive, a random start of the treatment cycle is the usual approach in Mount Sinai Fertility clinic, with no prior priming. The patient has a random serum levels of estrogen, progesterone, LH, FSH and ...

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • * Between the ages of 18 and 40.
  • * Undergoing IVF for fertility preservation (freezing all oocytes or embryos)
  • * Diagnosed with a non-hormone sensitive malignancy (malignancy other than breast, uterine and ovarian cancer)
  • * GnRH antagonist protocol (standard of care for all fertility preservation patients)
  • Exclusion Criteria:
  • * Any contraindication to treatment with gonadotropins (including medical history or risk factors for TE, hypersensitivity to gonadotropins or to any of the excipients).
  • * Congenital hypogonadotropic hypogonadism unrelated to the oncological condition.
  • * Previous adverse or allergic reaction to luteinizing hormone or any of its drug components.
  • * Had prior radiotherapy to the abdomen or pelvis
  • * Prior chemotherapy
  • * Prior history of deep vein thrombosis, or pulmonary embolism
  • * Patients with a diagnosis of hormone sensitive cancer including ovarian, uterine, or mammary carcinoma
  • * Patients with uncontrolled thyroid or adrenal failure
  • * Patients with active, untreated tumors of the hypothalamus and pituitary gland
  • * Patients who are lactating
  • * Patients with a known diagnosis of primary ovarian failure
  • * Previous participant of this study

About Ellen Greenblatt

Ellen Greenblatt is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. With extensive experience in the design and management of clinical trials, she leads initiatives that prioritize innovative therapeutic approaches and rigorous scientific methodologies. Ellen's collaborative approach fosters partnerships with research institutions and healthcare professionals, ensuring that clinical studies are conducted with integrity and adherence to regulatory standards. Her passion for enhancing health solutions drives her commitment to discovering new treatments that address unmet medical needs.

Locations

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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