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

NCT ID: NCT01225835

Last Updated: 2014-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-06-30

Brief 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

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Menotrophin

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.

Group Type: EXPERIMENTAL

Menotrophin

Intervention Type: DRUG

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.

Cetrorelix

Intervention Type: DRUG

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.

Choriongonadotropin

Intervention Type: DRUG

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.

Progesterone

Intervention Type: DRUG

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).

Follitrophin Alpha

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.

Group Type: ACTIVE_COMPARATOR

Follitrophin alpha

Intervention Type: DRUG

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.

Cetrorelix

Intervention Type: DRUG

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.

Choriongonadotropin

Intervention Type: DRUG

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.

Progesterone

Intervention Type: DRUG

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).

Interventions

Menotrophin

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.

Intervention Type: DRUG

Follitrophin alpha

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.

Intervention Type: DRUG

Cetrorelix

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.

Intervention Type: DRUG

Choriongonadotropin

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.

Intervention Type: DRUG

Progesterone

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 Type: DRUG

Other Intervention Names

Menogon® HP; Gonal-f®; Cetrotide®; GnRH antagonist; Brevactid®; human chorionic gonadotropin (hCG); Crinone®; intravaginal progesterone

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

• Minimum Eligible Age: 34 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ferring Arzneimittel GmbH

INDUSTRY

Sponsor Role: collaborator

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

Fertility Center Berlin

Berlin, , Germany

Praxisklinik Sydow am Gendarmenmarkt

Berlin, , Germany

Kinderwunschzentrum Dortmund

Dortmund, , Germany

Universitätsklinikum Duesseldorf, Frauenklinik

Düsseldorf, , Germany

Praxis für Kinderwunschbehandlung

Erlangen, , Germany

NOVUM Zentrum

Essen, , Germany

IVF Zentrum

Saar, , Germany

Endokrinologikum Ulm

Ulm, , Germany

Countries

Germany

Other Identifiers

2010-019411-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FE999906 CS11

Identifier Type: -

Identifier Source: org_study_id