A Prospective, Open Label, Randomised, Parallel Group Trial Comparing the Effects of Highly Purified Menotrophin and Recombinant Follicle Stimulating Hormone (rFSH, Follitropin alpha) Administered Subcutaneoulsy to Subfertile Female Patients Undergoing IVF Using Antagonist Down-Regulation on Progesterone Serum Levels During the Follicular Phase and their Possible Use as Predictors for the Success Rate of Ongoing Pregnancies (PREDICT) - PREDICT

Conditions: Controlled ovarian hyperstimulation to induce the development of multiple follicles for assisted reproductive technologies
MedDRA version: 14.0Level: PTClassification code 10021926Term: InfertilitySystem Organ Class: 10038604 - Reproductive system and breast disorders

Registration Number: EUCTR2010-019411-37-DE

Lead Sponsor: FERRING Arzneimittel GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

1. Signed informed consent
2. Subfertile premenopausal female patients eligible for IVF treatment
3. Aged >=34 and <= 42 years
4. Body mass index of >18 and <28 kg/m2
5. Normal pelvic ultrasound at Screening I (Visit 1)
6. No more than two previous gonadotrophin stimulated cycles of IVF or ICSI in the history
of infertility treatment (gonadotrophin stimulated cycles not used for IVF or ICSI do not
count; Clomifen cycles are no exclusion criterion)
7. At least 3 consecutive ovulatory menstrual cycles of 24-35 days, and documented evidence of ovulatory cycles within the previous 12 months prior to Screening I
8. No fertility stimulating drugs at all within the last 3 months prior to treatment start (Visit 3)
9. Sperm of partner classified as normal according to WHO 2010 criteria within the year prior to Visit 3
10. Negative urine beta human chorionic gonadotrophin (hCG) pregnancy test at Screening II (Visit 2)
11. Clinically normal baseline haematology, clinical chemistry, and urinalysis values at Screening I
12. Negative serum Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) antibody tests within the last 6 months prior to Screening I
13. Endocrine test results (E2, LH, FSH, P4, AMH (>1ng/ml), prolactin, TSH) in early follicular phase within the clinically normal limits at Screening

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Presence of any clinically relevant systemic disease (eg, insulin-dependent diabetes mellitus)
2. A history of or current endocrine disease (excluding treated hypothyreosis), including polycystic ovary syndrome (PCOS) and hyperprolactinaemia
3. A history of coagulation disorders
4. Persistent ovarian cysts (>3 months)
5. Contraindications for the use of gonadotrophins or GnRH antagonists
6. A history of hypersensitivity to any of the constituents of the study medication or related compounds
7. A history of alcohol abuse (more than 30 units per week on a regular basis)
8. History of chemo- or radiotherapy
9. Currently breast-feeding, pregnant or with a contraindication to pregnancy
10. Diagnosed poor (<3 oocytes) responders to prior gonadotrophin stimulated ART-cycle
11. History of severe OHSS (grade 4 or 5) in former gonadotrophin stimulated ART-cycle
12. Investigational drug within the last 30 days prior to Visit 3 or former enrolment into this study
13. Any other condition or history that the Investigator considers might increase the risk to the individual
14. Incapability to understand the aim, importance and consequences of the study and to give legal informed consent
15. Institutionalization due to regulatory or judicial order
16. Possible dependence on the Sponsor or Investigator