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

Not Applicable

Terminated

• Conditions: Infertility, Female
• Interventions: Drug: fostimon; Drug: puregon

• Registration Number: NCT01882166
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-06-17
• Study First Posted: 2013-06-20
• Study Start: 2013-10
• Primary Completion: 2015-01-01
• Study Completion: 2015-01-01
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-12
• Last Update Posted: 2018-09-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 20

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fostimon	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.
puregon	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.

Primary Outcome Measures

Name	Time	Method
Embryo quality	2 days	time-lapse recordings for all embryos will be evaluated by use of the EmbryoViewer (software developed for the EmbryoScope)

Trial Locations

Locations (1)

IVF Unit, St. Olavs Hospital; 🇳🇴 Trondheim, Norway