NCT03741699

Recombinant LH Prior to Ovarian Stimulation in Poor Ovarian Responders (PRE-LH)

A Phase III Multicentre, Randomized, Unblinded Clinical Trial to Test the Effect of Treatment with Recombinant LH Prior to Controlled Ovarian Stimulation in Poor Ovarian Responder Women with an Advanced Maternal Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Instituto Valenciano de Infertilidad, IVI Alicante · Academic / Other
• Sex: Female
• Age: 35 Years – 43 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infertility, Female

Interventions

Type	Name	Description
DRUG	Pre-treatment with rLH (Luveris 75 IU),	Treatment with 150 IU/day rLH (Luveris 75 IU), administered subcutaneously for 4 consecutive days prior to COS (Controlled ovarian stimulation)

Timeline

• Start date: 2019-02-18
• Primary completion: 2024-05-11
• Completion: 2024-05-11
• First posted: 2018-11-15
• Last updated: 2024-10-09

Locations

3 sites across 1 country: Spain