Progesterone Serum Levels in Subfertile Female Patients Undergoing in Vitro Fertilisation (IVF)
Condition: Infertility
MeSH terms: Infertility
Intervention: Menotrophin; Follitrophin alpha; Cetrorelix; Choriongonadotropin; Progesterone
Intervention description: Starting on Day 2 or 3 of the menstrual cycle, 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met.; Starting on Day 2 or 3 of the menstrual cycle, 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met.; Participants self-inject subcutaneously Cetrorelix in the morning at a daily dose of 0.25 mg/day from Day 5 of gonadotrophin administration on and continue throughout the period of gonadotrophin treatment up to day 12 as a maximum. The last dose of Cetrorelix is given on the day of ovulation induction.; 10,000 IU administered by the Investigator or designated personnel in the evening of the day on which the hCG criterion is met (no later than Day 13). The criterion for hCG administration is three follicles >+17 mm diameter as shown by pelvic ultrasound examination.; Vaginal gel progesterone is used once daily at a dose of 90 mg for a period of 30 days starting on the day of oocyte retrieval (approximately Day 14).
Intervention MeSH terms: Chorionic Gonadotropin; Cetrorelix; Menotropins; Progesterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 124.0
Sex: Female
Minimum age: 34 Years
Maximum age: 42 Years
Healthy volunteers: No

Summary:

      This study is aimed to demonstrate that highly purified Menotrophin produces significant
      lower progesterone serum levels during the follicular phase in comparison to Follitropin
      alpha in the treatment of subfertile females undergoing an in vitro fertilisation (IVF) and
      to investigate if the progesterone serum levels might be a useful predictor for the success
      rate of the ongoing pregnancy rates
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent

          -  Subfertile premenopausal female patients eligible for in vitro fertilisation (IVF)
             treatment

          -  Aged ≥34 and ≤42 years

          -  Body mass index of >18 and <28 kg/m^2

          -  Normal pelvic ultrasound at Screening

          -  No more than two previous gonadotrophin stimulated cycles of IVF or intracytoplasmic
             sperm injection (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)

          -  At least 3 consecutive ovulatory menstrual cycles of 24-35 days

          -  No fertility stimulating drugs at all

          -  Sperm of partner classified as normal according to World Health Organisation (WHO)
             2010 criteria

          -  Clinically normal baseline haematology, clinical chemistry, and urinalysis values

          -  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

          -  Endocrine test results within the clinically normal limits at Screening

        Exclusion Criteria:

          -  Presence of any clinically relevant systemic disease (e.g., insulin-dependent diabetes
             mellitus)

          -  A history of or current endocrine disease (excluding treated hypothyreosis), including
             polycystic ovary syndrome (PCOS) and hyperprolactinaemia

          -  A history of coagulation disorders

          -  Persistent ovarian cysts (>3 months)

          -  A history of hypersensitivity to any of the constituents of the study medication or
             related compounds

          -  Diagnosed poor (<3 oocytes) responders to prior gonadotrophin stimulated ART-cycle

          -  History of severe ovarian hyperstimulation syndrome in former gonadotrophin stimulated
             assisted reproductive technology (ART)-cycle