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

Launched by ELLEN GREENBLATT · Jan 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of adding a hormone called luteinizing hormone (LH) to the standard fertility medication, follicle-stimulating hormone (FSH), for women with certain types of cancer who want to preserve their fertility before starting cancer treatment. Research has suggested that women with cancer may have lower fertility even before treatment begins, which is why this trial aims to see if combining these hormones can help improve the chances of producing healthy eggs for freezing.

To participate in this trial, women need to be between the ages of 18 and 40 and diagnosed with a non-hormone sensitive cancer (meaning cancers other than breast, ovarian, or uterine). They must also be undergoing in vitro fertilization (IVF) for fertility preservation. Participants will receive either the combination of LH and FSH or FSH alone during their fertility treatment and will be monitored for safety and effectiveness. It’s important to note that this trial is not yet recruiting, so interested individuals will need to wait until the study starts.

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