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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01882166
Other study ID # 2013/600
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 2013
Est. completion date January 1, 2015

Study information

Verified date September 2018
Source St. Olavs Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date January 1, 2015
Est. primary completion date January 1, 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 38 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
fostimon

puregon


Locations

Country Name City State
Norway IVF Unit, St. Olavs Hospital Trondheim

Sponsors (1)

Lead Sponsor Collaborator
St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Embryo quality time-lapse recordings for all embryos will be evaluated by use of the EmbryoViewer (software developed for the EmbryoScope) 2 days
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