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

NCT01225835 | Completed Phase 4 Results

• 2 other identifiers: FE999906 CS112010-019411-37
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 8

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

Outcome Measures

Primary Outcomes (1)

• Serum Progesterone (P4) Level in the Morning of the Day of Human Chorionic Gonadotrophin (hCG) Administration

  Ovulation induction was performed by administration of hCG once three follicles \>=17 mm diameter as shown by pelvic ultrasound examination. This outcome compares the serum progesterone level the morning prior to hCG administration across treatment arm, and also by age stratum (\<39 years and \>=39 years).

  approximately day 10

Secondary Outcomes (17)

• Receiver Operating Characteristic (ROC) Analysis of Progesterone as Predictor for Ongoing Pregnancy Rate at Day 7 and Day of hCG Administration

  Day 7, approximately Day 10 (hCG Administration)

• Percentage of Participants With Ongoing Pregnancy

  approximately 3.5 months from study start (at least 9 weeks after first positive pregnancy test)

• Number of Follicles at hCG Administration

  approximately day 10

• Average Follicle Diameter at hCG Administration

  approximately day 10

• Number of Cumulus-oocyte Complexes Retrieved

  approximately day 12 after study start

Study Arms (2)

Menotrophin

EXPERIMENTAL

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.

Drug: Menotrophin; Drug: Cetrorelix; Drug: Choriongonadotropin; Drug: Progesterone

Follitrophin Alpha

ACTIVE COMPARATOR

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.

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

Interventions

Menotrophin 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.

Also known as: Menogon® HP

Menotrophin

Follitrophin alpha 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.

Also known as: Gonal-f®

Follitrophin Alpha

Cetrorelix 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.

Also known as: Cetrotide®, GnRH antagonist

Follitrophin Alpha; Menotrophin

Choriongonadotropin 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.

Also known as: Brevactid®, human chorionic gonadotropin (hCG)

Follitrophin Alpha; Menotrophin

Progesterone 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).

Also known as: Crinone®, intravaginal progesterone

Follitrophin Alpha; Menotrophin

Eligibility Criteria

• Age: 34 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead
• Ferring Arzneimittel GmbH: collaborator

Study Sites (8)

Fertility Center Berlin

Berlin, Germany

Location

Praxisklinik Sydow am Gendarmenmarkt

Berlin, Germany

Location

Kinderwunschzentrum Dortmund

Dortmund, Germany

Location

Universitätsklinikum Duesseldorf, Frauenklinik

Düsseldorf, Germany

Location

Praxis für Kinderwunschbehandlung

Erlangen, Germany

Location

NOVUM Zentrum

Essen, Germany

Location

IVF Zentrum

Saar, Germany

Location

Endokrinologikum Ulm

Ulm, Germany

Location

MeSH Terms

Conditions

Infertility

Interventions

Menotropins; Glycoprotein Hormones, alpha Subunit; follitropin alfa; cetrorelix; LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-; asialogalactochoriongonadotropin; Chorionic Gonadotropin; Progesterone; Crinone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Biological Products; Complex Mixtures; Follicle Stimulating Hormone; Luteinizing Hormone; Thyrotropin; Placental Hormones; Pregnancy Proteins; Proteins; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Progesterone Congeners; Gonadal Steroid Hormones

Results Point of Contact

• Title: Clinical Development Support
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: October 21, 2010
• Study Start: October 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 14, 2014
• Results First Posted: February 11, 2014

Record last verified: 2014-02

Locations

DE (8)