Study of the Cleavage of the Egg in Relation to the Stimulation Treatment

Ferring

Status: Completed

Conditions: Female Infertility

Study type: Observational

Funder types: Industry

Identifiers

NCT01674894

000063

Details and patient eligibility

About

This post-marketing, single-center prospective study will be conducted in an open-label, non-interventional setting, for women seeking fertility treatment and will describe cleavage dynamics in relation to the age of the oocyte and gonadotrophin treatment.

Enrollment: 356 patients

Sex: Female

Ages: 38 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. IVF/ICSI treatment
2. Regular cycles of 25-35 days
3. Follicle stimulation with Bravelle and/or Menopur
4. Women aged 38-35 years
5. Long agonist or short antagonist treatment
6. Willing and able to understand a Danish, English or German patient information form
7. Willing and able to provide written Informed Consent

Exclusion criteria

1. BMI more than 35
2. Presence of hydrosalpinx on ultrasound
3. FSH more than 13 or antral follicle count (AFC) less than 4 at fertility investigation
4. Known allergic reactions to the planned medications
5. Use of testicular sperm

Trial design

356 participants in 2 patient groups

Group 1

Description:

Women treated with Menopur

Group 2

Description:

Women treated with Menopur and Bravelle