Time-lapse Monitoring of Early Embryo Development After Ovarian Stimulation During Infertility Treatment

Study Overview
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Brief Summary
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The number of children conceived by assisted reproductive technology is increasing in Nordic countries as well as worldwide. An important factor of success in treatment of infertility is a short time to pregnancy with impact on both economical aspects for the society and medical and psychological aspects for the couple. During treatment, success relies on 1) optimal stimulation of growth and maturation of multiple follicles by administration of exogenous follicle stimulating hormone (FSH), and 2) selection of the fertilized egg / embryo with the highest potential of implantation to be transferred to the mother. In the present project stimulation of egg production by human urine derived FSH (Fostimon®) and recombinant FSH (Puregon®) will be compared. To this end early embryo development and kinetics after fertilization will be evaluated. The system to be used is time-lapse recording of embryo morphology during the first days of embryo development by means of an embryoscope. Aim of this study is to investigate if Puregon and urinary Fostimon have different effect on embryo quality. The hypothesis of the study is that stimulation of egg production by these two types of follicle stimulating hormone does not have the same effect on early embryo quality.

Official Title
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Time-lapse Monitoring of Early Embryo Development After Ovarian Stimulation During Infertility Treatment

Conditions
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Infertility, Female

Intervention / Treatment
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* Drug: fostimon
* Drug: puregon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First or second intracytoplasmic sperm injection (ICSI) treatment BMI 18-32 kg/m² No previous ovarian hyperstimulation syndrome (OHSS) Regular menstrual cycle (cycle length 28 ± 3 days Less than 20 antral follicles evaluated by vaginal ultrasound S- Anti-Müller Hormone (AMH) 10 - 40 pmol/L has given informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fostimon<br>subcutaneous 150 IE Fostimon®. When leading follicles are > 17 mm ovulation will be induced by Ovitrelle® 500μg sc(hCG-injection). Ovum pick up (OPU) will be performed 32-36 hours later. | Drug: fostimon<br> <br> * Other names: urinary FSH;|
| Experimental: puregon<br>subcutaneous 150 IE Puregon®. When leading follicles are > 17 mm ovulation will be induced by Ovitrelle® 500μg sc(hCG-injection). Ovum pick up (OPU) will be performed 32-36 hours later. | Drug: puregon<br> <br> * Other names: recombinant FSH;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Embryo quality | time-lapse recordings for all embryos will be evaluated by use of the EmbryoViewer (software developed for the EmbryoScope) | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fertilization in Vitro, Sperm Injections, Intracytoplasmic, Follicle Stimulating Hormone, Embryonic Development