Ovarian ReservePhase 2ELHANCT06883890
Extended LH Administration
A Phase 2 study testing Recombinant LH (Luveris) and No Treatment Added in people with Ovarian Reserve, run by Azienda Ospedaliero-Universitaria di Modena.
Trial 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 concentrations of receptors for LH (LH-R). LH modulates the progressive remodeling and growth of the follicle . Read more about this study
- Who is it for?
- Ages 25 to 38 years, women only
- Conditions the study is for
- Ovarian Reserve
- What is being tested?
- Recombinant LH (Luveris) and No Treatment Added
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 17 Mar 2025to 1 Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Extended LH Administration (ELHA), a Strategy to Increase the Pool of Recruitable Antral Follicles: a Multicentric Randomized Trial
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.
Read more
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
Read the 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 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:
- Change from baseline for basal AFC (antral follicle count) after 60 days of LH prolonged treatment or no treatment
- Change from baseline for basal AMH after 30 days of LH prolonged treatment or no treatment
- Change from baseline for basal AFC (antral follicle count) after 30 days of LH prolonged treatment or no treatment
- Ovarian response to controlled ovarian stimulation in IVF/ICSI cycles (number of follicles >16 mm at the end of stimulation, number of retrieved oocytes, FORT index- follicles to oocyte ratio, number of mature oocytes)
- Evaluate the safety of rLH throughout the treatment period
- cycles discontinued/cancelled before rhCG administration due to poor or excessive ovarian response
- percent of missed transfer of fresh embryos
- implantation rate
- biochemical pregnancy rate
- clinical pregnancy rate
- early (≤9 days after triggering) and late (12-17 days after triggering) OHSS onset (according to Golan's Classification System) rate
- miscarriage rate
- preterm birth rate
- low birth weight rate
- congenital anomalies rate
- gestational age at delivery
- mean neonatal weight
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.
- Conditions
- Ovarian Reserve
- Being tested
- Recombinant LH (Luveris), No Treatment Added
- Keywords
- AMH, AFC, Ovarian reserve, LH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant LH (Luveris)Drug
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.
No Treatment AddedDrug
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
| Study group | Role | What they receive |
|---|---|---|
| LH group | Active comparator | 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 Receives: Drug: Recombinant LH (Luveris) |
| Control group | Sham comparator | 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 Receives: Drug: No Treatment Added |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 18 months
Secondary outcomes (1)
Antral follicle count
Change from baseline for basal AFC (antral follicle count) after 60 days of LH prolonged treatment or no treatmen
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start17 Mar 2025 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian ReserveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio La Marca, Azienda Ospedaliero-Universitaria di Modena
- Investigators
- Antonio La Marca, MD, PhD, Principal investigator, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883890
- Sponsor's protocol ID
- EC 174/2023
- Other IDs
- 2022-004285-38
- Acronym
- ELHA
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
La Marca A, Longo M. Extended LH administration as a strategy to increase the pool of recruitable antral follicles in hypothalamic amenorrhea: evidence from a case series. Hum Reprod. 2022 Oct 31;37(11):2655-2661. doi: 10.1093/humrep/deac195.
PubMed 36107111
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended LH Administration (ELHA), a Strategy to Increase the Pool of Recruitable Antral Follicles: a Multicentric Randomized Trial
- ClinicalTrials.gov ID
- NCT06883890
- Acronym / sponsor ID
- ELHA / EC 174/2023
- Conditions
- Ovarian Reserve
- Keywords
- AMH, AFC, Ovarian reserve, LH
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ModenaUniversity, hospital or other
- Study start
- 17 Mar 2025 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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:
- Change from baseline for basal AFC (antral follicle count) after 60 days of LH prolonged treatment or no treatment
- Change from baseline for basal AMH after 30 days of LH prolonged treatment or no treatment
- Change from baseline for basal AFC (antral follicle count) after 30 days of LH prolonged treatment or no treatment
- Ovarian response to controlled ovarian stimulation in IVF/ICSI cycles (number of follicles >16 mm at the end of stimulation, number of retrieved oocytes, FORT index- follicles to oocyte ratio, number of mature oocytes)
- Evaluate the safety of rLH throughout the treatment period
- cycles discontinued/cancelled before rhCG administration due to poor or excessive ovarian response
- percent of missed transfer of fresh embryos
- implantation rate
- biochemical pregnancy rate
- clinical pregnancy rate
- early (≤9 days after triggering) and late (12-17 days after triggering) OHSS onset (according to Golan's Classification System) rate
- miscarriage rate
- preterm birth rate
- low birth weight rate
- congenital anomalies rate
- gestational age at delivery
- mean neonatal weight
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| LH group | Active comparator | Drug: Recombinant LH (Luveris)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 |
| Control group | Sham comparator | Drug: No Treatment AddedIn the control group, women will not receive any therapy and will be followed up with the same schedule as women in the treatment group |
Who may qualify
- Ages
- 25 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant LH (Luveris)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 | LH group |
| No Treatment AddedIn 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 | Control group |
Primary outcome
Anti-Mullerian Hormone
Time frame: up to 18 months
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
1 secondary outcome
Antral follicle count
Time frame: up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Results publication: PubMed 36107111La Marca A, Longo M. Extended LH administration as a strategy to increase the pool of recruitable antral follicles in hypothalamic amenorrhea: evidence from a case series. Hum Reprod. 2022 Oct 31;37(11):2655-2661. doi: 10.1093/humrep/deac195.
- Individual participant dataSharing planned: Undecided
Related trials for Ovarian Reserve
Not yet recruitingPhase 1
Oral GDC-0077 in Premature Ovarian Insufficiency
Primary Ovarian Insufficiency
Not yet recruiting
Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Diminished Ovarian Reserve
Diminished Ovarian Reserve (DOR)
RecruitingObservational study
Anti-Müllerian Hormone in Breast Cancer Clinical Practice
Breast Cancer
Recruiting
Study of Ovarian Reserve Concerning Patients With Multiple Sclerosis (MS), Compared to a Control Group
Multiple Sclerosis
Recruiting
Improving Women's Fertility Awareness and Reducing Anxiety Through Ovarian Reserve Screening and AI Counseling
Fertility Awareness, Ovarian Reserve
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonio La Marca, MD, PhD principal investigator
University of Modena and Reggio Emilia
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant LH (Luveris) and No Treatment Added in people with Ovarian Reserve, run by Azienda Ospedaliero-Universitaria di Modena.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio La Marca, MD, PhD (+390594225862, antonio.lamarca@unimore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-Mullerian Hormone (time frame: up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06883890, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.