Back to resultsTime-lapse Monitoring of Early Embryo Development After Ovarian Stimulation During Infertility Treatment
Primary Purpose
Infertility, Female
Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
fostimon
puregon
Sponsored by
About this trial
This is an interventional treatment trial for Infertility, Female focused on measuring Fertilization in Vitro, Sperm Injections, Intracytoplasmic, Follicle Stimulating Hormone, Embryonic Development
Eligibility Criteria
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
Sites / Locations
- IVF Unit, St. Olavs Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
fostimon
puregon
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Embryo quality
time-lapse recordings for all embryos will be evaluated by use of the EmbryoViewer (software developed for the EmbryoScope)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01882166
Brief Title
Time-lapse Monitoring of Early Embryo Development After Ovarian Stimulation During Infertility Treatment
Official Title
Time-lapse Monitoring of Early Embryo Development After Ovarian Stimulation During Infertility Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
principal investigator left for another job, project leader retired
Study Start Date
October 2013 (Actual)
Primary Completion Date
January 1, 2015 (Actual)
Study Completion Date
January 1, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
Keywords
Fertilization in Vitro, Sperm Injections, Intracytoplasmic, Follicle Stimulating Hormone, Embryonic Development
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fostimon
Arm Type
Experimental
Arm Description
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.
Arm Title
puregon
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
fostimon
Other Intervention Name(s)
urinary FSH
Intervention Type
Drug
Intervention Name(s)
puregon
Other Intervention Name(s)
recombinant FSH
Primary Outcome Measure Information:
Title
Embryo quality
Description
time-lapse recordings for all embryos will be evaluated by use of the EmbryoViewer (software developed for the EmbryoScope)
Time Frame
2 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arne Sunde, phd
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
IVF Unit, St. Olavs Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Time-lapse Monitoring of Early Embryo Development After Ovarian Stimulation During Infertility Treatment
We'll reach out to this number within 24 hrs