Progesterone Serum Levels in Subfertile Female Patients Undergoing in Vitro Fertilisation (IVF) (PREDICT)

Ferring

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Drug: Choriongonadotropin; Drug: Cetrorelix; Drug: Menotrophin; Drug: Follitrophin alpha; Drug: Progesterone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01225835

FE999906 CS11

2010-019411-37 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 124 patients

Sex: Female

Ages: 34 to 42 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

Menotrophin

Experimental group

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. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.

Treatment:

Drug: Progesterone

Drug: Choriongonadotropin

Drug: Cetrorelix

Drug: Menotrophin

Follitrophin Alpha

Active Comparator group

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. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.

Treatment:

Drug: Progesterone

Drug: Follitrophin alpha

Drug: Choriongonadotropin

Drug: Cetrorelix