A Study of the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant Follitropin Alfa

Infertility Clinical Trial

Official title:

A Prospective, Open Label, Randomised, Parallel Group, Comparative Pilot Study to Study the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant FSH (Follitropin Alfa) Administered Subcutaneously to Subfertile Female Patients Undergoing IVF Using Antagonist Downregulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00257556
• Other study ID #: FE999906 CS004 (PROSPECT)
• Secondary ID: 2004-001307-35
• Status: Completed
• Phase: Phase 4
• First received: November 22, 2005
• Last updated: February 12, 2010
• Start date: October 2005
• Est. completion date: April 2009

Study information

• Verified date: February 2010
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceGermany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Prospective open label, randomised, parallel group, comparative pilot.

Description:

Ongoing pregnancy rate, defined as positive fetal heart action 9 weeks after the first positive pregnancy test. Number/diameter of follicles, number of oocytes retrieved, number of pronuclear oocytes (referred to as zygotes or pre-embryos in the UK), quality of pronuclear stage oocytes, number of embryos transferred, quality of embryos, number of frozen embryos, endometrial thickness and morphology on day of HCG administration, estradiol levels at day of HCG administration, implantation rate, number of days stimulated with gonadotrophins and number of ampoules used, clinical pregnancy rate at 6 weeks after the first positive pregnancy test, pregnancy outcome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Female patients aged > or = 20 and < or = 35 years with a BMI of >18 and <32 kg/m2 who have received no more than two previous cycles of in vitro fertilisation (IVF) or other assisted reproductive technique (ART) and whose partners have normal sperm (according to WHO 1999 criteria).

Inclusion criteria:

• Signed informed consent;

• Subfertile premenopausal female patients eligible for IVF treatment;

• Aged >=20 and <=35 years;

• Body mass index of >18 and <32 kg/m2

• Normal endocrine assessment within the last 6 months;

• Normal pelvic ultrasound (showing two ovaries, no ovarian abnormalities and normal uterus) within the last 6 months;

• Receipt of no more than two previous cycles of IVF (or other ART);

• At least 3 consecutive ovulatory menstrual cycles of 24-35 days, and documented evidence of ovulatory cycles within the previous 12 months;

• No fertility-modifying treatment within the 3 months prior to this treatment cycle;

• Infertility attributable to or in association with either tubal factor, or unexplained causes;

• Sperm of partner classed as normal according to WHO 1999 criteria within the year prior to beginning therapy;

• Negative serum beta-HCG pregnancy test prior to beginning therapy;

• Clinically normal baseline haematology, clinical chemistry, and urinalysis parameter values, negative serum HBsAg and HIV antibody tests;

• Screening endocrine test results (estradiol, LH, FSH, progesterone, prolactin, TSH) in early follicular phase within the normal limits for the clinical laboratory.

Exclusion criteria

• Presence of any clinically relevant systemic disease(e.g. insulin- dependent diabetes mellitus);

• A history of or current endocrine disease, including polycystic ovary- like syndrome and hyperprolactinaemia;

• A history of coagulation disorders;

• Persistent ovarian cysts;

• Contraindications for the use of gonadotrophins or GnRH antagonists;

• A history of hypersensitivity to any of the constituents of the study medication or related compounds;

• Three or more previous cycles of IVF (or other ART);

• A history of alcohol abuse (more than 30 units per week on a regular basis);

• History of chemo- or radiotherapy;

• Currently breast-feeding, pregnant or with a contraindication to pregnancy;

• Diagnosed poor responders in prior IVF treatment;

• History of severe ovarian hyperstimulation syndrome (OHSS) (4 or 5) in former IVF treatment;

• Investigational drug within the 30 days prior to treatment;

• Any other condition or history that the investigator considers might increase the risk to the individual.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Menotrophin
150 IU Menotrophin daily subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily.
• Follitropin alfa
150 IU follitropin alfa daily by subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily.

Locations

Country	Name	City	State
Germany	Gemeinschaftspraxis und Tagesklinik, Olpe 19	Dortmund
Germany	Universitats-Frauenklinik Heidelberg Abt. Gynakologische Endokrinologie und Fertilitatsstorungen, Voßstr. 9	Heidelberg
Germany	Gemeinschaftspraxis und Tagesklinik, Zingel 29	Hildesheim
United Kingdom	Royal Infirmary of Edinburgh, 51 Little France	Edinburgh
United Kingdom	Leeds General Infirmary, Great George Street	Leeds
United Kingdom	The Royal Hallamshire Hospital, University of Sheffield, Jessop Wing, Tree Root Walk	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With an Ongoing Pregnancy		Approx week 13; 9 weeks or more after the 1st positive pregnancy test	No
Primary	Percentage of Participants With an Ongoing Pregnancy		Approx week 13; 9 weeks or more after the first positive pregnancy test	No
Secondary	Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters		Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13)	No
Secondary	Participants With Varying Numbers of Oocytes Retrieved		Approximately study day 15	No
Secondary	Participants With Varying Numbers of Pronuclear Stage Oocytes		Approximately study day 15	No
Secondary	Participants With Varying Numbers of Embryos Transferred		Approximately study day 17	No
Secondary	Participants With Varying Numbers of Embryos Frozen		Approximately study day 17	No
Secondary	Mean Number of Days Stimulated With Gonadotrophins		study days 1 - 13	No
Secondary	Pregnancy Outcomes		Approximately 10 months	No
Secondary	Mean Endometrial Thickness		Day 7 or 9 or 11 or 13	No
Secondary	Mean Estradiol Level		Day 7 or 9 or 11 or 13	No