Recombinant LH Prior to Ovarian Stimulation in Poor Ovarian Responders (PRE-LH)
Status:
Recruiting
Trial end date:
2023-05-31
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Instituto Valenciano de Infertilidad, IVI Alicante
Collaborators:
Fundación IVI Merck, S.L., Spain Syntax for Science, S.L