Status:
NOT_YET_RECRUITING
Extended LH Administration
Lead Sponsor:
Azienda Ospedaliero-Universitaria di Modena
Conditions:
Ovarian Reserve
Eligibility:
FEMALE
25-38 years
Phase:
PHASE2
Brief Summary
Luteinizing hormone (LH) plays an important role in follicular development, especially in the later stages of folliculogenesis. Theca interstitial cells and, later, granulosa cells express high concen...
Detailed Description
Primary objective The primary endpoint of the study will be to confirm that the pre-treatment with rhLH at the dose of 187.5 IU/day for 60 days may improve ovarian reserve as indicated by an increase ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- AFC of at least 5 in the 3 months prior to the study cycle
- Basal AMH levels of at least 1 ng/ml in the 3 months prior to the study cycle
- Age 25-38 at the moment of the study cycle
- D3 Basal LH: 1-6 IU/L in the 3 months prior to the study cycle
- D3 Basal FSH: \< 8 IU/L in the 3 months prior to the study cycle 13
- D3 Estradiol \< 70 pg/ml in the 3 months prior to the study cycle
- Willing to participate
- Capable to understand and follow the study procedure
- eumenorrheic women with low LH levels candidate to IVF/ICSI cycle for tubal factor, male factor or for idiopathic infertility
- Acceptance and signature of the informed consent
- Exclusion criteria:
- PCOS patients according to Rotterdam's criteria
- Patients with irregular cycles (shorter than 25 days or longer than 35 days)
- Patients already treated with LH priming
- Patients planning to undergo duo/double stimulation
- Patients with ASRM Stage III or IV endometriosis
- Patients with prior surgery significantly affecting ovary (ie ovariectomy, cystectomy significantly reducing ovarian volume or others) as assessed by the responsible gynecologist
- Previous cycle with less than 4 oocytes recovered
- Patients treated with hormones in the 3 months before the study
- 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)
- previous episode of OHSS or exuberant ovarian response to gonadotropins
- hypersensitivity to the study drug
- contraindication for pregnancy
- porphyria or a family history of porphyria
- history of ovarian torsion
- BMI \> 30 kg/m2
- ovarian enlargement or ovarian cyst
- gynecological bleeding of unknown origin
- history of ovarian, breast or endometrial cancer.
Exclusion
Key Trial Info
Start Date :
March 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06883890
Start Date
March 17 2025
End Date
September 1 2026
Last Update
March 19 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.