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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-01-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

fostimon

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

puregon

Intervention Type DRUG

Interventions

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fostimon

Intervention Type DRUG

puregon

Intervention Type DRUG

Other Intervention Names

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urinary FSH recombinant FSH

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No