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

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ClinicalTrials.gov Identifier: NCT01882166
Recruitment Status : Terminated (principal investigator left for another job, project leader retired)
First Posted : June 20, 2013
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
St. Olavs Hospital

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.

Condition or disease Intervention/treatment Phase
Infertility, Female Drug: fostimon Drug: puregon Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Time-lapse Monitoring of Early Embryo Development After Ovarian Stimulation During Infertility Treatment
Actual Study Start Date : October 2013
Actual Primary Completion Date : January 1, 2015
Actual Study Completion Date : January 1, 2015

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Arm Intervention/treatment
Experimental: fostimon
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
Other Name: urinary FSH

Experimental: puregon
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
Other Name: recombinant FSH




Primary Outcome Measures :
  1. Embryo quality [ Time Frame: 2 days ]
    time-lapse recordings for all embryos will be evaluated by use of the EmbryoViewer (software developed for the EmbryoScope)



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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01882166


Locations
Norway
IVF Unit, St. Olavs Hospital
Trondheim, Norway, 7006
Sponsors and Collaborators
St. Olavs Hospital
Investigators
Study Chair: Arne Sunde, phd St. Olavs Hospital

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT01882166     History of Changes
Other Study ID Numbers: 2013/600
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018

Keywords provided by St. Olavs Hospital:
Fertilization in Vitro
Sperm Injections, Intracytoplasmic
Follicle Stimulating Hormone
Embryonic Development

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female