Evaluation of Corifollitropin Alfa Versus Follitropin Beta in Oocyte Donors Undergoing Medroxyprogesterone Acetate-Induced Pituitary Suppression

The primary objective of this study is to compare the number of total **oocytes** and metaphase II (MII) oocytes obtained after controlled ovarian stimulation using **Corifollitropin alfa** versus **Follitropin beta** in oocyte donors. These donors undergo pituitary suppression with **medroxyprogesterone acetate** (MPA) to prevent early luteinization. This comparison is clinically relevant as it may provide insights into optimizing ovarian stimulation protocols, potentially improving outcomes in assisted reproductive technologies for female infertility.

The clinical trial focuses on **female infertility** and involves a study population exclusively composed of female participants. The age range for participants is between 18 and 35 years, with a requirement for a regular menstrual cycle of 25 to 35 days. Participants are expected to be in good general health, with a body mass index (BMI) between 18 and 28 kg/m². The trial excludes individuals with any physical or mental illness, polycystic ovaries, or any significant personal or family medical history. Participants must have a normal uterus and ovaries without organic pathology, an antral follicle count greater than 12, and a normal karyotype. Screening for infectious diseases such as Hepatitis B, Hepatitis C, HIV, and Syphilis must be negative, and general health parameters should be within normal limits. The sponsor has not provided information regarding the total number of participants in the trial. The selection process for the trial population is based on these specific health and lifestyle criteria, ensuring a homogenous group for the study's objectives.

The clinical trial is designed to evaluate the efficacy of **Corifollitropin alfa** as an alternative to conventional daily recombinant follicle-stimulating hormone (rFSH) protocols in oocyte donors undergoing pituitary suppression with medroxyprogesterone acetate (MPA). This study is a randomized, double-blind, controlled trial, categorized as a Phase III study, and is expected to run from December 1, 2023, to March 31, 2025. The primary objective is to compare the number of total oocytes and metaphase II (MII) oocytes obtained after controlled ovarian stimulation with Corifollitropin alfa versus Follitropin beta in donors. The primary endpoint is the number of MII oocytes and the mature oocyte rate.

Participants will be involved in the study for a maximum treatment period of 20 days. The trial includes several key visits: an initial screening visit to confirm eligibility based on criteria such as age, menstrual cycle regularity, and health status; follow-up visits to monitor ovarian response and adjust treatment as necessary; and an end-of-study visit to assess the primary and secondary endpoints. The inclusion criteria require participants to be females aged 18 to 35 years with a regular menstrual cycle, a body mass index (BMI) between 18 and 28 kg/m², and no significant medical history or polycystic ovaries. Participants must also have a normal uterus and ovaries, an antral follicle count greater than 12, a normal karyotype, and negative screening for infectious diseases.

Participants may be withdrawn from the study if they experience adverse effects, fail to comply with the study protocol, or if the investigator deems it necessary for their safety. The study will utilize a solution for injection as the route of administration for both Corifollitropin alfa and Follitropin beta. The trial is classified as low intervention, focusing on the efficacy of the treatment regimen. The study aims to provide valuable insights into the management of female infertility, specifically in the context of oocyte donation.

The clinical trial involves the administration of **Corifollitropin alfa**, a gonadotropin used for controlled ovarian stimulation. The pharmaceutical form of Corifollitropin alfa is a solution for injection, identified by the code PHF00231MIG. The maximum daily dose is 150 µg, with a total dose not exceeding 150 µg over a treatment period of one day. This medication is administered via subcutaneous injection. Corifollitropin alfa is classified under the ATC code G03GA09 and is not a paediatric formulation. It is used as a test product in this study to evaluate its efficacy as an alternative to conventional daily recombinant follicle-stimulating hormone (rFSH) protocols in oocyte donors.

**Follitropin beta** serves as the comparator treatment in this trial. It is also a gonadotropin, administered as a solution for injection, with the same pharmaceutical form code PHF00231MIG. The maximum daily dose for Follitropin beta is 225 IU, with a total dose limit of 4500 IU over a maximum treatment period of 20 days. This medication is administered via subcutaneous injection. Follitropin beta is classified under the ATC code G03GA06 and is not formulated for paediatric use. The study aims to compare the outcomes of ovarian stimulation using Corifollitropin alfa against Follitropin beta in the context of oocyte donation, with both treatments being used in conjunction with medroxyprogesterone acetate to prevent early luteinisation.

Efficacy in this clinical trial will be assessed by comparing the number of total oocytes and **metaphase II (MII) oocytes** obtained after controlled ovarian stimulation using two different treatments: Corifollitropin alfa and Follitropin beta. The primary endpoint for evaluating efficacy is the number of MII oocytes and the mature oocyte rate. These parameters will be measured to determine the effectiveness of the treatments in oocyte donors who have undergone pituitary suppression with medroxyprogesterone acetate (MPA) to prevent early luteinization.