Low Dose Gonal-f in Ovulation Induction (LoGo)

• Research type

  Research Study

• Full title

  A Multi-Centre, Two-Arm, Interventional, Phase IV Study to Evaluate Tailoring of Recombinant FSH Treatment in Subjects with Chronic Anovulation Using the Gonal-f® Prefilled Pen in Women Undergoing Ovulation Induction

• IRAS ID

  108485

• Contact name

  Roy Homburg

• Sponsor organisation

  Merck Serono Ltd

• Eudract number

  2012-003227-38

• ISRCTN Number

  n/a

• Research summary

  The study will compare two follicle stimulating hormone treatment regimens. Arm A (Experimental) will start at 50 IU for one week, then increase at incremen's of 12.5 IU to 75 IU with a final increase of 25 IU in the 4th week (if required). Arm B (Established Dose) will start at 50 IU for 1 week, then increase at incremen's of 25 IU for up to 4 weeks. Both areas will use Gonal-f (injected subcutaneously) as the follicle stimulating hormone. Arm B represents a common treatment protocol used for ovulation induction (OI). The study will investigate whether Arm A is non-inferior (i.e. no worse than) to the standard treatment, within a margin of 20%. The study will enrol female subjects suffering from chronic anovulation (no monthly release of an egg) who are desirous of pregnancy. Subjects must have failed to ovulate, orisuccessfully ovulated but failed to conceive after clomifene citrate treatment (an oral fertility treatment) and therefore potentially be suitable for treatment with gonadotropinsEligible subjects will be randomised in a 1:1 ratio to the two study areas. All subjects will be treated with Gonal -f (at the assigned dose) for a maximum of 4 weeks. If, following treatment, subjects achieve adequate follicular development (their follicles grow enough) they will proceed to injection of human chorionic gonadotropin (hCG), intercourse/insemination and pregnancy testing. Subjects will be followed up until confirmation of clinical pregnancy. The study design broadly reflects standard clinical practice for ovulation induction treatment. The maximum study duration is approximately 70 days ( up to 1 month screening) for subjects who become pregnant, and approximately 40 days ( up to 1 month screening) for subjects who do not become pregnant. The study will be conducted at both n's and private fertility clinics.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  13/LO/0037

• Date of REC Opinion

  7 Mar 2013

• REC opinion

  Further Information Favourable Opinion