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

St. Olavs Hospital

Status: Terminated

Conditions: Infertility, Female

Treatments: Drug: puregon; Drug: fostimon

Study type: Interventional

Funder types: Other

Identifiers

NCT01882166

2013/600

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

fostimon

Experimental group

Description:

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.

Treatment:

Drug: fostimon

puregon

Experimental group

Description:

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.

Treatment:

Drug: puregon