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

NCT06227949 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: MS200061_0066
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

IVF; fertility preservation; oncofertility; rLH; FSH; cryopreservation

Outcome Measures

Primary Outcomes (1)

• Total number of mature (MII) oocytes available for cryopreservation

  12hrs after egg retrieval

Secondary Outcomes (9)

• Total number of oocytes retrieved per cycle

  1hr after egg retrieval

• Ratio of mature (MII) to immature oocytes

  12 hours after egg retrieval

• Total number of mature oocytes (MII) retrieved per IVF/ICSI cycle

  12 hours after egg retrieval

• Ratio of mature (MII) to immature oocytes per IVF/ICSI cycle

  12 hours after egg retrieval

• Number of two pronuclei (2PN) zygotes

  48 hours after egg retrieval

Study Arms (2)

Control

NO INTERVENTION

subcutaneous injection of Gonal-F (FSH)

Intervention

EXPERIMENTAL

subcutaneous injection of Luveris in addition to Gonal-F (FSH)

Drug: Luveris

Interventions

Luveris DRUG

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ellen Greenblatt: lead
• EMD Serono: collaborator

MeSH Terms

Interventions

Luteinizing Hormone, beta Subunit

Intervention Hierarchy (Ancestors)

Luteinizing Hormone; Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Ellen Greenblatt, MD FRCSC

  Mount Sinai Fertility, Mount Sinai Hospital, University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellen Greenblatt, MD FRCSC

CONTACT

416 596 5046; ellen.greenblatt@sinaihealth.ca

Swati Dixit, PhD

CONTACT

4165868888; swati.dixit@sinaihealth.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Patients will be randomly assigned in a 1:1 ratio to either treatment or control group. Treatments in each of the trial arms will be as follows: 1. Treatment arm: Patients will self-administer a subcutaneous injection of Gonal-F (FSH) in addition to Luveris daily until a pre-set criteria to trigger ovulation is reached. 2. Control arm: Patients will self-administer a subcutaneous injection of Gonal-F (FSH) daily until a pre-set criteria to trigger ovulation is reached.

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 29, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2031
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data requests can be submitted starting 6 months after article publication and data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact swati.dixit@sinaihealth.ca.