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. - PROSPECT

Phase 1

• Conditions: sub fertility; MedDRA version: 7.1 Level: LLT Classification code 10042391

• Registration Number: EUCTR2004-001307-35-GB
• Lead Sponsor: Ferring Arzneimittel GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-22
• Study Completion: 2008-07-18
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 72

Inclusion Criteria

The patients must meet all of the following inclusion criteria

Signed informed consent;

Subfertile premenopausal female patients eligible for IVF treatment;

Aged more than or equal to 20 and less than or equal to 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The patient may not be entered into the study if any of the following exclusion criteria exist.

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 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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to compare highly purified Menotrophin with Follitropin alfa with respect to ongoing pregnancy (determined by positive fetal heart action at more than or equal to 9 weeks after the first positive pregnancy test) in the treatment of 60 subfertile females undergoing IVF using a GnRH antagonist protocol to supress endogenous FSH and LH. ;Primary end point(s): Ongoing pregnancy rate, defined as positive fetal heart action at more than or equal to 9 weeks after the first positive pregnancy test, after the IVF treatment cycle.;Secondary Objective: The secondary objective of this study is to compare the efficacy of highly purified Menotrophin with that of Follitropin alfa with respect to the secondary efficacy endpoints in the treatment of 60 subfertile females undergoing IVF using a GnRH antagonist protocol to supress endogenous FSH and LH.