Phase 4
Completed N=80
A Study of the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant Follitropin Alfa
Source: ClinicalTrials.gov NCT00257556 ↗Enrolled (actual)
80
Serious AEs
17.1%
Results posted
Feb 2010
Primary outcomePrimary: Number of Participants With an Ongoing Pregnancy — 14; 13 participants
Summary
Prospective open label, randomised, parallel group, comparative pilot.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With an Ongoing Pregnancy |
14; 13 | — |
| PRIMARY Percentage of Participants With an Ongoing Pregnancy |
37.8; 33.3 | — |
| SECONDARY Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters |
10; 3; 11; 11; 7; 10 | — |
| SECONDARY Participants With Varying Numbers of Oocytes Retrieved |
1; 0; 1; 1; 3; 1 | — |
| SECONDARY Participants With Varying Numbers of Pronuclear Stage Oocytes |
1; 0; 8; 6; 1; 3 | — |
| SECONDARY Participants With Varying Numbers of Embryos Transferred |
0; 1; 3; 1; 21; 28 | — |
| SECONDARY Participants With Varying Numbers of Embryos Frozen |
16; 22; 1; 0; 2; 1 | — |
| SECONDARY Mean Number of Days Stimulated With Gonadotrophins |
9.2; 8.9 | — |
| SECONDARY Pregnancy Outcomes |
4; 4; 1; 1; 2; 3 | — |
| SECONDARY Mean Endometrial Thickness |
11.7; 11.0 | — |
| SECONDARY Mean Estradiol Level |
6706.6; 6268.3 | — |
Eligibility Criteria
Female patients aged > or = 20 and 18 and =20 and 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.
Data sourced from ClinicalTrials.gov (NCT00257556). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.