Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients

NCT01312766 | Completed Phase 3 Results

• 2 other identifiers: 10EU/hMG022010-021021-13
• Study Type: interventional
• Target: 270
• Locations: 5 countries
• Sites: 6

Brief Summary

The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous hMG preparations when administered to patients undergoing controlled ovarian stimulation for IVF.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Total Number of Oocytes Retrieved

  up to 24 days after treatment start

Secondary Outcomes (12)

• Mean hMG Dose (Total);

  up to 22 days after treatment start

• Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo)

  up to 28 days after treatment start

• Positive b-hCG Test

  up to 5 weeks after treatment start

• Controlled Ovarian Stimulation Duration (Days)

  up to 23 days after treatment start

• 17-β Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection;

  up to 23 days after treatment start

Study Arms (2)

hMG-IBSA

EXPERIMENTAL

New hMG preparation.

Drug: Menotropins

Menopur

ACTIVE COMPARATOR

Drug: Menotropins

Interventions

Menotropins DRUG

Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.

hMG-IBSA

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women undergoing ovarian stimulation for IVF with the following characteristics:
• Able and willing to sign the Patient Consent Form and adhere to the study visitation schedule
• \>18 and \<40 years old
• BMI between 18 and 30 kg/m2
• less than 3 previously completed IVF cycles (i.e. completed cycle = egg recovery)
• basal FSH \<10 IU/L and E2 \<80 pg/ml (\~290 pmol/l)
• Within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through transvaginal ultrasound, hysterosalpingogram, sonohysterogram or hysteroscopic examination
• Successful down-regulation performed with a standard GnRH-Agonist long protocol (Criteria for successful down-regulation: endometrial thickness \< 7mm or serum E2 level \<50 pg/ml (\~185 pmol/l).

You may not qualify if:

• age \<18 and \>40 years
• primary ovarian failure or women known as poor responders (i.e. requiring more than 225 IU of hMG as a starting dose in previous treatment cycles or having less than 3 oocytes retrieved, or with a pre-ovulatory E2 serum concentration \<500pg/ml (\~1800 pmol/l))
• PCOS
• one or both ovaries inaccessible for oocyte retrieval
• ovarian cysts \>10 mm
• hydrosalpinx that have not been surgically removed or ligated;
• stage 3 or 4 endometriosis
• oocyte donation
• implantation of previously frozen embryos
• patients affected by pathologies associated with any contraindication of being pregnant
• hypersensitivity to the study medication
• abnormal bleeding of undetermined origin
• uncontrolled thyroid or adrenal dysfunction
• neoplasias
• severe impairment of renal and/or hepatic function

Sponsors & Collaborators

• IBSA Institut Biochimique SA: lead

Study Sites (6)

Fertility clinic at Hvidovre Hospital

Hvidovre, Copenhagen, 2650, Denmark

Location

Odense Universitetshospital

Odense, Odensee C, 5000, Denmark

Location

Groupe Hospitalier Cochin - Saint Vincent de Paul

Paris, 75014, France

Location

First Dept. Obstetric and Gynaecology, Semmelweiss University

Budapest, 1088, Hungary

Location

Universitätsspital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Midland Fertility Services

Aldridge, West Midlands, WS9 8LT, United Kingdom

Location

MeSH Terms

Conditions

Infertility

Interventions

Menotropins

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

Results Point of Contact

• Title: Dr. Barbara Cometti, Senior Clinical Research Manager, IBSA
• Organization: IBSA Institut Biochimique SA

barbara.cometti@ibsa.ch

+41 58 360 10 00

Study Officials

• Dominique De Ziegler, MD, Prof

  Hopital Cochin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2011
• First Posted: March 11, 2011
• Study Start: February 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 22, 2016
• Results First Posted: August 15, 2014

Record last verified: 2016-06

Locations

DK (2); CH (1); GB (1); HU (1); FR (1)