NCT01882166

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 20, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

September 14, 2018

Status Verified

September 1, 2018

Enrollment Period

1.3 years

First QC Date

June 17, 2013

Last Update Submit

September 12, 2018

Conditions

Infertility, Female

Keywords

Fertilization in VitroSperm Injections, IntracytoplasmicFollicle Stimulating HormoneEmbryonic Development

Outcome Measures

Primary Outcomes (1)

  • Embryo quality

    time-lapse recordings for all embryos will be evaluated by use of the EmbryoViewer (software developed for the EmbryoScope)

    2 days

Study Arms (2)

fostimon

EXPERIMENTAL

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

puregon

EXPERIMENTAL

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

Interventions

fostimonDRUG
Also known as: urinary FSH
fostimon
puregonDRUG
Also known as: recombinant FSH
puregon

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVF Unit, St. Olavs Hospital

Trondheim, 7006, Norway

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Urofollitropinfollitropin beta

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

MenotropinsGonadotropins, PituitaryGonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Arne Sunde, phd

    St. Olavs Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2013

First Posted

June 20, 2013

Study Start

October 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

September 14, 2018

Record last verified: 2018-09

Locations

NO(1)