A Study on Efficacy and Safety of Menopur® Multidose in Korean Female Patients With Infertility

Study Overview
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Brief Summary
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The purpose of this study is to investigate the ongoing pregnancy rates at 10-11 weeks after embryo transfer in patients treated with Menopur® Multidose

Official Title
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Non-Interventional Clinical Study on Efficacy and Safety of Highly Purified Human Menopausal Gonadotrophin (HP-hMG) Menopur® Multidose in Korean Female Patients With Infertility

Conditions
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Infertility

Intervention / Treatment
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* Drug: Menotrophin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Decision made to prescribe Menopur® multidose according to Summary of product characteristics The study cycle will be either 1st controlled ovarian stimulation cycle ever, or 2nd controlled ovarian stimulation cycle ever, or 1st or 2nd controlled ovarian stimulation cycle after having achieved ongoing pregnancy in a previous controlled ovarian stimulation cycle (note: the subject cannot be included if she has had made more than one failed cycle before the cycle resulting in ongoing pregnancy) Exclusion Criteria: Known ovarian disease (e.g. ovarian cysts, polycystic ovarian disease etc.) Diagnosed as poor responder, defined as either >20 days of gonadotrophin stimulation in a previous controlled ovarian stimulation cycle, or any previous cancellation of a controlled ovarian stimulation cycle due to limited follicular response, or development of less than 4 follicles ≥15 mm in a previous controlled ovarian stimulation cycle Ovarian hyperstimulation syndrome (OHSS)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Menopur® Multidose<br>Treatment according to routine clinical practice. | Drug: Menotrophin<br> <br> * Other names: Menopur® Multidose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate | Defined as presence of at least 1 intrauterine pregnancy with a viable fetus | 10-11 weeks after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Follicle Stimulating Hormone (FSH) level |  | At baseline and last stimulation day (max 20 days after start of stimulation) | 
| Mean Luteinizing Hormone (LH) level |  | At baseline and last stimulation day (max 20 days after start of stimulation) | 
| Mean Estradiol 2 (E2) level |  | At baseline and last stimulation day (max 20 days after start of stimulation) | 
| Mean endometrial thickness | Measured by transvaginal ultrasound | On last stimulation day (max 20 days after start of stimulation) | 
| Follicular development | Number and size of follicles measured by transvaginal ultrasound | On last stimulation day (max 20 days after start of stimulation) | 
| Number of oocytes retrieved |  | 36 hours (±2h) after human Chorionic Gonadotrophin (hCG) administration | 
| Fertilization rate | Number of oocytes with 2 pronuclei divided by number of metaphase II oocytes | 1 day after oocyte retrieval |