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

Phase 3

Completed

• Conditions: Infertility
• Interventions: Drug: Menotropins

• Registration Number: NCT01312766
• Lead Sponsor: IBSA Institut Biochimique SA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-03-07
• Study First Submitted QC: 2011-03-09
• Study First Posted: 2011-03-11
• Primary Completion: 2013-04
• Study Completion: 2013-12
• Results First Submitted: 2014-02-28
• Results First Submitted QC: 2014-07-28
• Results First Posted: 2014-08-15
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-10
• Last Update Posted: 2016-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 270

Inclusion Criteria

• 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).

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Exclusion Criteria

• 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
• use of concomitant medications that might interfere with study evaluations (e.g. non-study hormonal medications, prostaglandin inhibitors, psychotropic agents)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Menopur	Menotropins	-
hMG-IBSA	Menotropins	New hMG preparation.

Primary Outcome Measures

Name	Time	Method
Total Number of Oocytes Retrieved	up to 24 days after treatment start

Secondary Outcome Measures

Name	Time	Method
Positive b-hCG Test	up to 5 weeks after treatment start
Total Number of Inseminated Oocytes (IVF and ICSI)	on the day of oocyte retrieval	number of oocytes that were inseminated via IVF or injected via ICSI technique.
Number of Cleaved Embryos	two days after insemination
Live Birth Rate	9 months after treatment
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	Assessed by counting the total number of embryos obtained, the number of embryos transferred, frozen and discarded.
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
Implantation Rate	10-11 weeks after embryo transfer	defined as the mean of the total number of implanted embryos (presence of gestational sac assessed by ultrasound) divided by the total number of transferred embryos x 100;
Clinical Pregnancy Rate,	10 - 11 weeks after embryo transfer	defined as a pregnancy showing ultrasound embryonic heart activity at 10 - 11 weeks after embryo transfer;
Number of Mature (Grade III Metaphase II) Oocytes Retrieved.	at the end of the stimulation.
Ratio Mature/Total Number of Oocytes Retrieved.	at the end of the stimulation.	Percentage of retrieved oocytes considered to be mature.

Trial Locations

Locations (6)

Fertility clinic at Hvidovre Hospital; 🇩🇰 Hvidovre, Copenhagen, Denmark

Midland Fertility Services; 🇬🇧 Aldridge, West Midlands, United Kingdom

Odense Universitetshospital; 🇩🇰 Odense, Odensee C, Denmark

First Dept. Obstetric and Gynaecology, Semmelweiss University; 🇭🇺 Budapest, Hungary

Groupe Hospitalier Cochin - Saint Vincent de Paul; 🇫🇷 Paris, France

Universitätsspital Basel; 🇨🇭 Basel, BS, Switzerland