Efficacy of Corifollitropin Alfa in Obese Women in Terms of Clinical and Molecular Parameters of IVF Success

Phase 4

Completed

Brief Summary: The aim of the present study is to determine, whether clinical efficacy of 150 mcg of Corifollitropin alfa is the same in normal weighing and obese women. Furthermore, investigators want to determine whether oocytes retrieved from normal weighing and obese women, after COH using 150 mcg of Corifollitropin alfa, are of same quality on the molecular level.

Detailed Description: The dosage of Corifollitropin alfa used for controlled ovarian hyperstimulation (COH) is adjusted according to the patient's body weight. Meaning, in women with a body weight ≤ 60 kg, a single dose of 100 mcg of Corifollitropin alfa is administered for COH and in women with a body weight \> 60 kg, a single dose of 150 micrograms of Corifollitropin alfa is administered for COH. These two protocols are comparable in safety and efficacy of follicular stimulation.

On the other hand, knowledge about the clinical efficacy of 150 mcg of Corifollitropin alfa in obese women (BMI\>30 kg/m2) is lacking.

Cumulus cells (CC) surround the oocyte and bi-directional communication between oocyte and CC is necessary for the development of mature and quality oocytes. It has been proposed, that analysis of genes, expressed in CC, can serve as an objective indicator of the oocyte's maturity and developmental potential. Expression of genes in CC as hyaluronan synthase 2 (HAS2), follicle-stimulating hormone receptor (FSHR), versican (VCAN), progesterone receptor (PR), vascular endothelial growth factor C (VEGFC), serine protease inhibitor E2 (SERPINE2), glutathione peroxidase (GPX3), pentraxin 3(PTX3) was reported to correlate with oocyte maturity and developmental potential.

The effect of Corifollitropin alfa on expression of these genes however, is unknown.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

polycystic ovary syndrome, severely abnormal sperm parameters, and age > 38 years

Arm && Interventions

Group	Intervention	Description
Elonva 150 mcg	Elonva	Elonva 150 mcg intramuscular daily obese
Elonva 100 mcg	Elonva	Elonva 100 mcg intramuscular daily normal weight

Primary Outcome Measures

Name	Time	Method
Number of Fertilized Oocytes	1 month
Number of Frozen Embryos	1 month
Number of Mature Oocytes	1 month	Number of mature oocytes obtained was compared between groups
Number of Oocytes Retrieved Per Patient	1 month	Number of oocytes obtained in the study group was compared to the number of oocytes obtained in the control group
Biochemical Pregnancy Rate	1 year

Secondary Outcome Measures

Name	Time	Method
Real-time PCR Analysis of Genes That Were Proposed as Biomarkers of Oocyte Quality to Determine Effect of Corifollitropin Alpha on Oocyte Quality on Molecular Level	12 months	Expression of some genes that were proposed as biomarkers of oocyte quality was analysed in CC using real-time PCR. Relative expression values of genes were compared between mature oocytes derived from obese women and mature oocytes derived from normal weighing women.