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Extended LH administration (ELHA), a strategy to increase the pool of recruitable antral follicles: a multicentric randomized trial
EU CTIS ID: 2024-517407-36-00
What this study is testing
The primary objective of the study is to confirm that pre-treatment with rhLH at the dose of 187.5 IU/day for 60 days can improve ovarian reserve as indicated by an increase in basal AMH.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 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
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.