Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03737253 |
| Other study ID # |
2016_467 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2016 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
April 2022 |
| Source |
Lund University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim is to be able to predict the hormonal response according to gonadotropin receptor
genotype and hormone type used for treatment of women undergoing in vitro fertilization or
egg donation.
Outcome will be measured as pregnancy success, live born babies and unwanted side effects.
Description:
Women undergoing in vitro fertilization receive high doses of the gonadotropins follicle
stimulating hormone (FSH) and human chorionic gonadotropin (hCG), which is acting as
luteinizing hormone (LH) for stimulation of the ovaries in order to obtain a high number of
eggs. There are however marked individual differences in the hormonal response, ranging from
lack of increased egg maturation to hyper stimulation. The hypothesis is that genetic
variants in the gonadotropin receptors (LH and FSH receptors), are influencing the outcome.
This assumption is supported by a recent study on more than 600 women undergoing in vitro
fertilization, demonstrating that whereas only 10% of women with asparagine in both genes
(FSHR N680S and LHR N312S) became pregnant, 40% of those with serine did (Lindgren I et al.
Hum Repr 2016; 3:672-83).
Most (90%) of the women were treated with rFSH (recombinant). However, of the 10% asparagine
carriers who actually became pregnant, most if not all, were treated with menotropin - a
urine derivated compound (Menopur, Ferring), which contains both LH and FSH. This finding was
not stressed in the manuscript as it could have been due to chance because of the small
number of women treated with menotropin.
The objective is therefore to perform a prospective randomized study regarding efficacy of
treatment in the first and second in vitro fertilization trial with rFSH and menotropin,
respectively, genotype taken into account.
In total 890 women, 445 in Poznan, Poland and 445 in Malmö, Sweden, with unexplained
infertility or a male or tubal factor indication for treatment will be invited to participate
in the study. At first appointment, information is provided and informed consent retrieved.
Two blood samples are drawn and stored at -20°C; one for subsequent genotyping and one for
anti mullerian hormone measurement. The succeeding treatment is according to normal
procedures at respective clinic.
