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

NCT06227949 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2024-01-29

No results posted yet for this study

Summary

Fertility preservation has been performed before the initiation of cancer therapy as cancer therapy is known to be toxic for ovarian function. However, recent studies have shown that ovarian function is reduced in cancer patients even before they start cancer therapy. Reduced ovarian function has been shown by these patients having fewer mature oocytes (female eggs) and lower peak levels of estradiol (a type of estrogen hormone important for fertility). Other studies have shown that in some types of cancers, cancer patients have lower levels of anti-Müllerian hormone, which is a hormone measured to assess how many eggs patient has remaining in the body. Because of these poorer fertility markers shown in cancer patients prior to therapy, some doctors and researchers believe that alternative medications for stimulating ovaries may prove to be beneficial for stimulating the ovaries during fertility preservation.

Currently, luteinizing hormone injections are approved by Health Canada for patients with hypothalamic dysfunction. Hypothalamic dysfunction is a condition whereby lower levels of fertility hormones are produced because of brain dysfunction. Other reasons luteinizing hormone is used in clinical practice is in patients with poor ovarian reserve and patients who are older.

Recent research studies have suggested that some oncology patients may be poor responders prior to cancer therapy because of their underlying disease. The exact reasons for this poor response are not known. However, some researchers believe it may be related to the interactions between the brain and fertility organs, similar to patients with hypothalamic dysfunction. Because of this possible similarity to patients with hypothalamic dysfunction, adding luteinizing hormone to follicle-stimulating hormone (the hormone typically used for ovarian stimulation) may be beneficial for fertility preservation. Studies have also shown improved fertility outcomes with the addition of luteinizing hormone in non-cancer patients who were previously known to be poor responders to ovarian stimulation.

The clinical trial team is aiming to conduct a randomized controlled trial to evaluate the safety and efficacy of luteinizing hormone in non-hormone sensitive cancer patients (patients with cancer other than the breast, ovary or uterus).

Conditions

  • Fertility Preservation

Interventions

DRUG

Luveris

Patients will self-administer a subcutaneous injection of Luveris in addition to Gonal-F (FSH) daily until a pre-set criteria to trigger ovulation is reached.

Sponsors & Collaborators

  • EMD Serono

    collaborator INDUSTRY

  • Ellen Greenblatt

    lead OTHER

Principal Investigators

  • Ellen Greenblatt, MD FRCSC · Mount Sinai Fertility, Mount Sinai Hospital, University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2029-12-31
Completion
2031-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06227949 on ClinicalTrials.gov