Prospective Randomised Clinical Study on Pharmacogenetics of Gonadotropin Receptors in Relation to Pregnancy and Life Birth Rate as Well as Unwanted Side Effects Such as Ovarian Hyper Stimulation Syndrome During Assisted Reproduction.

2016_467

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.

2018-11-01

2021-12-31

2024-05-31

Completed

Early phase I

796

Inclusion Criteria: * 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 Exclusion Criteria: * Anti Müllerian Hormone \<5pmol or cycle day 2-3 FSH \>12 * Endometriosis * polycystic ovarian syndrome * pre ovarian failure * smoking * male age more than 56.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Women undergoing in vitro fertilization are randomized to either menotropin (urin derivate) or recombinant follicle stimulating hormone.\n\nInclusion criteria are:\n\n* younger than 40 years of age\n* more than 12 months of unprotected intercourse\n* normal ovulatory cycles 26-32 days\n* first or second IVF treatment\n* indication for IVF is male factor\n* tubal factor or unexplained infertility.\n\nExclusion criteria are:\n\n* Anti müllerian hormone less than 5pmol or FSH more than 12 cycle day 2-3\n* Endometriosis\n* polycystic ovarian syndrome\n* pre ovarian failure\n* smoking\n* male age more than 56.\n\nThe succeeding treatment is according to normal procedures at respective clinic.\n\nEnd points are: total hormonal dosage, number of retrieved oocytes, fertilization rate, rate of blastocyst transfer, pregnancy rate, live birth rate.\n\nAdverse effects e.g overstimulation is recorded.', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Patients and care providers need to know the type of hormone provided in order to be able to instruct and treat the patient. However, all roles are masked regarding the genotype.', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 796, 'type': 'ACTUAL'}}

2024-07-02