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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by St. Olavs Hospital
Sponsor:
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT01882166
First received: June 17, 2013
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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 Intervention
Infertility, Female
Drug: fostimon
Drug: puregon

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Time-lapse Monitoring of Early Embryo Development After Ovarian Stimulation During Infertility Treatment

Resource links provided by NLM:


Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • Embryo quality [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    time-lapse recordings for all embryos will be evaluated by use of the EmbryoViewer (software developed for the EmbryoScope)


Estimated Enrollment: 150
Study Start Date: October 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01882166

Contacts
Contact: Peter M Kragh, phd Peter.Michael.Kragh@stolav.no

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

No publications provided

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT01882166     History of Changes
Other Study ID Numbers: 2013/600
Study First Received: June 17, 2013
Last Updated: July 21, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014