A Phase 2 interventional study of Recombinant LH (Luveris) and No Treatment Added in Ovarian Reserve, sponsored by Azienda Ospedaliero-Universitaria di Modena. Not yet recruiting. Open to female participants aged 25 Years to 38 Years. Per ClinicalTrials.gov, last updated 2025-03-19.
Sponsored by Azienda Ospedaliero-Universitaria di Modena · Phase 2, Interventional, and Treatment
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 concentrations of receptors for LH (LH-R). LH modulates the progressive remodeling and growth of the follicle .
New evidence points to a role for LH in promoting ovarian follicle growth and maturation, even at very early stages of folliculogenesis. Studies analyzing LH-R expression profiles in the ovary have shown that LH-R is moderately expressed even in the smallest follicles, during what is known as the gonadotropin-independent phase . Immunohistochemical studies that examined the localization of LH-R in human follicles through different stages of follicular development reveal that LH-R is expressed by granulosa cells and some thecal cells in small pre-antral follicles LH promotes the transition of follicles to the antral stage, thus leading to an increase in functional ovarian reserve. Early follicular stages, particularly those between the primordial and pre-antral stages, are critical as they regulate the rate of follicle recruitment. The potential roles of LH in the early follicular phase were analyzed in a prospective, randomized multicenter study using a sequential approach to stimulation with recombinant human r-LH, followed by r-FSH, in women in hypogonadotropic hypogonadism because they were profoundly down-regulated by the administration of depo agonist GnRH analog. LH treatment was associated with an increase in small antral follicles before FSH stimulation and a higher number of normally fertilized embryos. In addition, AMH hormone was found to be significantly increased in both groups during the week prior to FSH stimulation These results seem to indicate that, if the reduction in the number of antral follicles is not due to a decrease in the number of primordial follicles, but to a slowing of progression, as in the case of women with long-standing hypothalamic amenorrhea, there may be room for a therapeutic approach. This is with the aim of improving the response to ovarian stimulation of the aforementioned patients who present with anovulatory cycles and in a condition of hypogonadotropic hypogonadism.
A recent case series described two patients suffering from hypothalamic amenorrhea with very low levels of endogenous gonadotropins, and ovulatory factor infertility. These patients were treated with exogenous LH for one to two months (prolonged administration of LH). Increased levels of both AMH and AFC were demonstrated, and they responded adequately to ovarian stimulation.
The purpose of this multicenter prospective randomized study follows recent publications confirming the implementation of ovarian reserve by supplementation with pretreatment with r-LH, a drug already on the market and routinely used in conventional controlled ovarian stimulation protocols.
The aim is to confirm that pretreatment with rhLH at a dose of 185.5 IU/day for 60 days can improve ovarian reserve, as indicated by increased baseline AMH and AFC, compared with no pretreatment. The primary outcome is serum AMH value after treatment with r-LH and without.
The planned duration of the study is 18 months, and a total of 84 patients are to be recruited. Patients will be randomized into two groups: group A who will receive pre-treatment with r-LH 185.5IU/day for 60 days and group B who will not receive pre-treatment.
Patients will have a monitoring visit every two weeks for the duration of treatment, during which an ultrasound and blood sampling will be performed to evaluate the hormonal picture. Following pretreatment, a visit of with assessment of serum AMH and AFC value will be performed and the planned IVF cycle will be started. This will be followed by an additional final follow-up visit to collect obstetric and newborn outcomes that will be conducted by telephone
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 in basal AMH.
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 in basal AMH. The chosen dose and duration for the study was based on a recent published article. In particular in this study women who presented for fertility treatment with very low functional ovarian reserve, showed that the administration of LH 187.5 IU/day for 60 days, contributed to a clinically evident increase in the functional ovarian reserve (AFC and AMH levels). The use of recombinant LH in women with gonadotrophin deficiency has been already investigated in two very well known randomized trials. In these two trials a dose of rec LH up to 225IU daily has been tested.
The objective of the European Recombinant Human LH study group was to conduct a randomized, efficacy clinical study with rLH in order to determine the minimal effective dose of rLH for supporting rFSH-induced follicular development in LH- and FSH-deficient anovulatory women (HH) in addition to assessing the safety and tolerability of this treatment. Patients were randomized to receive rLH (0, 25, 75, or 225IU/day) in addition to a fixed dose of rFSH (150 IU/day). rhLH was found 1) to promote dose-related increases in estradiol (E2) and androstenedione secretion by rFSH-induced follicles, 2) to increase ovarian sensitivity to FSH, as demonstrated by the proportion of patients who developed follicles after the administration of a fixed dose of FSH, and 3) to enhance theability of these follicles to luteinize when exposed to hCG. Recombinant LH, given sc at a dose up to 225 IU/day, was not immunogenicand was well tolerated.
In one study two double-blind, placebo-controlled, multicentre pilot studies were conducted. Study A was conducted in hypogonadotrophic hypogonadal women (WHO group I anovulation) with severe deficiency in LH and who were willing to conceive. Study B was conducted in WHO group II anovulatory patients (PCO) willing to conceive and who over-responded to FSH therapy. In the study A women received FSH plus LH at a dose of 225 IU daily. In the study B women were randomized to receive a dose of 225 IU or 450 IU daily. Authors reported that the Treatment with rLH was well tolerated. There were no serious or signficant adverse events during the study. No patient developed anti-LH antibodies.
Secondary objectives
The secondary endpoints will be:
This is a multicenter clinical trial. The coordinating center is the Mother-Infant Department of University Hospital of Modena and Reggio Emilia (Principal investigator [PI]: Prof. La Marca Antonio)
This two-arm, multicenter, prospective, RCT (proof of concept) trial with two treatment arms at 2:1 ratio will involve couples attending an IVF/ICSI cycle, phase II study.
Azienda Ospedaliero-Universitaria di Modena is the lead sponsor of 48 studies on the registry; 20 are open to participants now.
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Exclusion criteria:
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In the treatment group patients will receive the pretreatment with rLH, a daily dose of 187.5 IU (75 U in the morning and 112.5U in the evening) rLH treatment for 60 days will be administered
Drug: Recombinant LH (Luveris)
In the control group, women will not receive any therapy and will be followed up with the same schedule as women in the treatment group
Drug: No Treatment Added
In the treatment group patients will receive the pretreatment with rLH, a daily dose of 187.5 IU (75 U in the morning and 112.5U in the evening) rLH treatment for 60 days will be administered.
In the control group, women will not receive any therapy and will be followed up with the same schedule as women in the treatment group
Anti-Mullerian Hormone
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 in basal AMH
Time frame: up to 18 months
Antral follicle count
Change from baseline for basal AFC (antral follicle count) after 60 days of LH prolonged treatment or no treatmen
Time frame: up to 18 months
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Mar 2025; primary completion for Nov 2025, 7 months later.
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Studies of the drug tested here: Luteinizing Hormone
Azienda Ospedaliero-Universitaria di Modena