A Phase 3 interventional study of Pre-treatment with rLH (Luveris 75 IU), in Infertility, Female, sponsored by Instituto Valenciano de Infertilidad, IVI Alicante. Completed at 3 sites in Spain. Open to female participants aged 35 Years to 43 Years. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by Instituto Valenciano de Infertilidad, IVI Alicante · Phase 3, Interventional, and Treatment
Controlled ovarian stimulation (COS) is one of the first stages of assisted reproductive treatment. The goal is to mimic the ovarian cycle while stimulating the ovaries to overproduce eggs capable of being fertilized, thus maximizing the chances of reproductive success. The stimulation phase involves the use of different hormonal medications but requires tests to check the development of follicles, and hormonal adjustment to get the optimal ovarian response to stimulation.
However, between 9 to 24% of patients fail to respond adequately to standard stimulation protocols, resulting in Poor Ovarian Response (POR). In addition to the low oocyte production, POR results in a restricted number of good quality embryos with appropriate implantation potential, suggesting a compromised oocyte quality.
POR is one of the most challenging problems in reproductive medicine. Poor responders are difficult to treat since their response to stimulation tend to be deficient even when using different drugs or protocols. In recent years, different therapeutic alternatives have been proposed for these patients. However, to date, the optimal stimulation protocol has not yet been described and oocyte donation is often offered as their only option to achieve pregnancy.
Recently, evidence has emerged that supplementation with a specific hormone, luteinizing hormone (LH), during or prior to COS could lead to improved reproductive outcomes in poor responders by increasing the number of oocytes retrieved and improving their quality.
The present study aims to evaluate the effect of the treatment with LH prior to COS on the ovarian response in patients with POR and advanced maternal age, the worst prognosis but more frequent group of poor responders attending fertility clinics. We will assess whether LH treatment prior to COS increases the number and quality of oocytes retrieved in those patients and, finally, analyse the impact in their chances of getting pregnant and having a baby.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 88 is below the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Instituto Valenciano de Infertilidad, IVI Alicante is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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-Patients with POR according to specific criteria that are in line with the criteria defined by the ESHRE (Bologna Criteria), according to which a patient is classified as a poor ovarian responder when she meets two of the three of the following criteria: I.- Previous episode of POR (≤3 oocytes) with conventional stimulation protocol II.- Abnormal ovarian reserve test with an antral follicle count (AFC) \<5-7 and/or anti-mullerian hormone values (AMH) \<0.5-1.1 ng/mL.
III.- Women ≥40 years old and/or who have any other risk factor for POR. In addition, two episodes of POR after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal ovarian reserve test.
Exclusion Criteria:
Treatment with 150 IU/day rLH, administered subcutaneously for 4 consecutive days prior to COS (with a starting dose of 225 IU/day rFSH and 75 IU/day rLH for 18 days maximum in a short antagonist protocol).
Drug: Pre-treatment with rLH (Luveris 75 IU),
The subjects assigned to this group will not receive any treatment in the four days prior to COS (with a starting dose of 225 IU/day rFSH and 75 IU/day rLH for 18 days maximum in a short antagonist protocol).
Treatment with 150 IU/day rLH (Luveris 75 IU), administered subcutaneously for 4 consecutive days prior to COS (Controlled ovarian stimulation)
number of oocytes retrieved
number of oocytes retrieved
Time frame: 37 days
Number of follicles >17 mm on the previous day or the day of GnRH agonist injection (Decapeptyl)
Time frame: from day 8-12 to day 33-37
P 4 and E 2 levels on the previous day or the day of GnRH agonist injection
Time frame: from day 8-12 to day 33-37
Duration of stimulation and total gonadotropin dose during COS
Time frame: from day 8-12 to day 33-37
Serum hormonal profile before and after IMP treatment and after stimulation
Time frame: from day 8-12 to day 33-37
Cycle cancellation rates (stimulation cycle cancelled prior to oocyte retrieval if there is no follicular response after 10 days of stimulation or due to premature ovulation at any time before oocyte retrieval)
Time frame: from day 8-12 to day 33-37
Number of mature or metaphase II (MII) oocytes/number of oocytes retrieved per puncture
Time frame: Day 37
Number of retrieved oocytes/number of expected oocytes (follicles >15 mm on the day of GnRH agonist injection)
Time frame: Day 37
Fertilization rate
Time frame: Day 38
Hormonal profile in follicular fluid on the day of the puncture
Time frame: Day 37
Gene expression profile in granulosa cells
Time frame: Day 37
Apoptosis rate in granulosa cells
Time frame: Day 37
Morphological variables of embryonic quality
Time frame: Day 38 to 43
Blastocyst rate
Time frame: Day 43
Number of optimal embryos (type A or B, according to ASEBIR classification)
Time frame: Day 43
Number of euploid and aneuploid embryos
Time frame: Day 50
Stimulation cycle yield (number of frozen embryos).
Time frame: Day 43
Number of cycles with embryo transferred/ number of stimulation cycle started
Time frame: Day 43
Pregnancy rates (per stimulation cycle and embryo transfer)
Time frame: Throughout the study, estimate 1 year
Implantation rates
Time frame: Throughout the study, estimate 1 year
Ongoing pregnancy rates (per stimulation cycle and embryo transfer)
Time frame: Throughout the study, estimate 1 year
Clinical and biochemical miscarriages rates (per stimulation cycle and embryo transfer)
Time frame: Throughout the study, estimate 1 year
Ectopic pregnancy rates (per stimulation cycle and embryo transfer)
Time frame: Throughout the study, estimate 1 year
Live birth rates
Time frame: Throughout the study, estimate 18 +/-3 months
Assessment and recording of adverse events
Time frame: Throughout the study, estimate 18 +/-3 months
Plan to share: Undecided
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Instituto Valenciano de Infertilidad, IVI Alicante