Comparing Highly Purified hMG With Recombinant FSH + Recombinant LH in Women Undergoing Intrauterine Insemination.
Status:
Completed
Trial end date:
2009-05-01
Target enrollment:
Participant gender:
Summary
The present study aims to elucidate if the FSH and LH activity contained in hMG preparations
is comparable to the recombinant FSH and LH administration in a 1:1 ratio. The mean outcome
is the corresponding ovarian response in terms of oestradiol increase during stimulation and
number of mature follicles the day of hCG administration. The patients will be included and
randomized into two groups and stimulated either by HMG injections started on day 3 at a dose
of 75 IU every day and fixed for the first 5 days, and in the second group, rFSH and rLH
injections be started on day 3 at a dose of 75 UI/day of rFSH + 75UI/day of rLH. Serum
estradiol levels will be measured on stimulation day 1, day 6 and the day of hCG injection.
All follicles greater than 14 mm of diameter will be recorded on hCG day Intrauterine
insemination is performed during two consecutive days starting the day after the human
chorionic gonadotrophin (Ovitrelle) injection. Secondary outcomes are Days of stimulation,
Total doses of gonadotrophins administrated, Clinical pregnancy , Ongoing pregnancy and
Miscarriage rate, and Cancellation rate.
Phase:
Phase 4
Details
Lead Sponsor:
Instituto Valenciano de Infertilidad, IVI VALENCIA