Clinical trial NCT00257556: A Study of the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant Follitropin Alfa
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-11-23
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective open label, randomised, parallel group, comparative pilot.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With an Ongoing Pregnancy
timeFrame: Approx week 13; 9 weeks or more after the 1st positive pregnancy test
measure: Percentage of Participants With an Ongoing Pregnancy
timeFrame: Approx week 13; 9 weeks or more after the first positive pregnancy test
Secondary outcomes:
measure: Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters
timeFrame: Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13)
measure: Participants With Varying Numbers of Oocytes Retrieved
timeFrame: Approximately study day 15
measure: Participants With Varying Numbers of Pronuclear Stage Oocytes
timeFrame: Approximately study day 15
measure: Participants With Varying Numbers of Embryos Transferred
timeFrame: Approximately study day 17
measure: Participants With Varying Numbers of Embryos Frozen
timeFrame: Approximately study day 17
measure: Mean Number of Days Stimulated With Gonadotrophins
timeFrame: study days 1 - 13
measure: Pregnancy Outcomes
timeFrame: Approximately 10 months
measure: Mean Endometrial Thickness
timeFrame: Day 7 or 9 or 11 or 13
measure: Mean Estradiol Level
timeFrame: Day 7 or 9 or 11 or 13
Other outcomes:
Locations:
city: Dortmund
country: Germany
facility: Gemeinschaftspraxis und Tagesklinik, Olpe 19
city: Heidelberg
country: Germany
facility: Universitats-Frauenklinik Heidelberg Abt. Gynakologische Endokrinologie und Fertilitatsstorungen, Voßstr. 9
city: Hildesheim
country: Germany
facility: Gemeinschaftspraxis und Tagesklinik, Zingel 29
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh, 51 Little France
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary, Great George Street
city: Sheffield
country: United Kingdom
facility: The Royal Hallamshire Hospital, University of Sheffield, Jessop Wing, Tree Root Walk
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: