Extended LH Administration

Launched by AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA · Mar 17, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating whether a hormone treatment called recombinant luteinizing hormone (r-LH) can help improve ovarian reserve in women who have certain fertility issues, specifically those with low hormone levels and irregular menstrual cycles. The study aims to find out if taking r-LH for 60 days before undergoing fertility treatments can increase important markers of ovarian health, such as serum anti-Müllerian hormone (AMH) levels and the number of small follicles in the ovaries, compared to women who do not receive this treatment.

To participate in this trial, women aged 25 to 38 who have a minimum number of small follicles and normal hormone levels may be eligible. Participants can expect regular check-ups every two weeks during the treatment period to monitor their hormone levels and ovarian response, followed by an evaluation of their fertility outcomes. It’s important to note that certain conditions, like polycystic ovary syndrome (PCOS) or previous significant ovarian surgeries, would exclude someone from participating in this study. The trial is not yet recruiting, but it aims to enroll 84 participants over the next 18 months to gather valuable insights into improving fertility treatments for women facing these challenges.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. AFC of at least 5 in the 3 months prior to the study cycle
• • 2. Basal AMH levels of at least 1 ng/ml in the 3 months prior to the study cycle
• • 3. Age 25-38 at the moment of the study cycle
• • 4. D3 Basal LH: 1-6 IU/L in the 3 months prior to the study cycle
• • 5. D3 Basal FSH: \< 8 IU/L in the 3 months prior to the study cycle 13
• • 6. D3 Estradiol \< 70 pg/ml in the 3 months prior to the study cycle
• • 7. Willing to participate
• • 8. Capable to understand and follow the study procedure
• • 9. eumenorrheic women with low LH levels candidate to IVF/ICSI cycle for tubal factor, male factor or for idiopathic infertility
• • 10. Acceptance and signature of the informed consent
• Exclusion criteria:
• • 1. PCOS patients according to Rotterdam's criteria
• • 2. Patients with irregular cycles (shorter than 25 days or longer than 35 days)
• • 3. Patients already treated with LH priming
• • 4. Patients planning to undergo duo/double stimulation
• • 5. Patients with ASRM Stage III or IV endometriosis
• • 6. Patients with prior surgery significantly affecting ovary (ie ovariectomy, cystectomy significantly reducing ovarian volume or others) as assessed by the responsible gynecologist
• • 7. Previous cycle with less than 4 oocytes recovered
• • 8. Patients treated with hormones in the 3 months before the study
• • 9. Patients with an already known endocrinological disease including hypothyroidism (defined by TSH \< 4 mIU/L), adrenocortical deficiency (ACTH stimulation test (250 mcg) with basal cortisol \<3 mcg or, if basal cortisol is 3-18 mcg serum level, cortisol serum level 30 minutes after the stimulation test \<18 mcg) and hyperprolactinemia (PLR \> 25mcg/l)
• • 10. previous episode of OHSS or exuberant ovarian response to gonadotropins
• • 11. hypersensitivity to the study drug
• • 12. contraindication for pregnancy
• • 13. porphyria or a family history of porphyria
• • 14. history of ovarian torsion
• • 15. BMI \> 30 kg/m2
• • 16. ovarian enlargement or ovarian cyst
• • 17. gynecological bleeding of unknown origin
• • 18. history of ovarian, breast or endometrial cancer.