Hormone Evaluation in Artificial Reproductive Technology
- Conditions
- Female Infertility
- Interventions
- Registration Number
- NCT03737253
- Lead Sponsor
- Lund University
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 810
- Normal ovulatory cycles 26-32 days
- First and second IVF treatment
- Indication for IVF is male factor, tubal factor or unexplained infertility
- Medical indication for IVF; >12 months unprotected intercourse
- Anti Müllerian Hormone <5pmol or cycle day 2-3 FSH >12
- Endometriosis
- polycystic ovarian syndrome
- pre ovarian failure
- smoking
- male age more than 56.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Follitropin alpha Menotropin Follitropin alpha (GONAL-f, Merck-Serono, Darmstadt, Germany), injections, dosage varying 1500-2500 IU, duration 2-5 days. Menotropin Menotropin Menotropin (Menopur, Ferring GmbH, Kiel, Germany), injections, dosage varying 1500-2500 IU, duration 2-5 days. Follitropin alpha Follitropin alpha Follitropin alpha (GONAL-f, Merck-Serono, Darmstadt, Germany), injections, dosage varying 1500-2500 IU, duration 2-5 days. Menotropin Follitropin alpha Menotropin (Menopur, Ferring GmbH, Kiel, Germany), injections, dosage varying 1500-2500 IU, duration 2-5 days.
- Primary Outcome Measures
Name Time Method Pregnancy up to 12 months after treatment Association between pregnancy rate and genotype is evaluated
- Secondary Outcome Measures
Name Time Method Number of oocytes up to 6 months after treatment Number of eggs developed in response to drug according to genotype is measured
live birth up to 12 months after treatment Live birth rate according to genotype is analyzed
Trial Locations
- Locations (2)
Reproductive Medicine Center
🇸🇪Malmö, Sweden
Poznan University of Medical Sciences
🇵🇱Poznań, Poland