Infertile Female. Female infertility, unspecified
Conditions
Interventions
Intervention 1: Intervention group: Choriogonadotropin alfa (Behrad Gene Pharmed Company): 0.5 ml prefilled syringe containing (250 micrograms) of recombinant choriogonadotropin alfa, for single-dose
Sponsors
Behrad Gen Pharmed company
Eligibility
Sex/Gender
Female
Age
18 Years to 38 Years
Inclusion criteria
Inclusion criteria: 18 to 38 years old females Signing an informed consent form and willing to participate in the study and ability to cooperate with the study VISITs Regular menstruation cycles (21 to 35 days) Body mass index (BMI) between 18-30 kg/m2 At least one year of infertility history Normal AMH (1.2-3.5) or AFC of each ovary is = 5 Both ovaries being present and clinically normal Fresh Embryo Transfer plan Normal serum levels of hormones
Exclusion criteria
Exclusion criteria: Plan to participate in another clinical study or administration of investigational products within prior month History of more than 3 ET procedures Patients who have PCOS as diagnosed by their doctor Irregular vaginal bleeding with unknown cause Any malignancy history Grade III/IV endometriosis active thromboembolic disorders (clot formation in blood vessels) Patients with uterine abnormalities History of ovarian hyper stimulation syndrome (OHSS) or PCOS with a risk of OHSS People who have been diagnosed with hyperprolactinemia by a doctor. Having uncontrolled diseases Endocrine disorders, insulin-dependent diabetes, seizures, neurological disorders such as severe migraine, chronic cardiovascular disorders, Thyroid and adrenal disorder,? hepatic, pulmonary, renal, or gastrointestinal disorders, corticosteroid-dependent severe asthma, or any other chronic or acute disorder making the subject unfit to enroll the study from the point of the investigator Ovarian failure Breastfeeding women Azoospermic male patients Known allergies or hypersensitivity or contraindication towards FSH, HCG, progesterone, and GnRH antagonists Hypersensitivity to the formulation and its active ingredient Drug or alcohol abuse history in the past 2 years Human gonadotropin drugs (HCG, LH, FSH) use within the last 2 months HIV infection or hepatitis B or C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of cumulus-oocyte complexes obtained per patient receiving r HCG. Timepoint: 34 to 36 hours after administration of study drug. Method of measurement: Microscope. | — |
Secondary
| Measure | Time frame |
|---|---|
| Total number of mature oocytes obtained. Timepoint: 0 to 1 hour after coc. Method of measurement: Microscope.;Total number of immature oocytes retrieved. Timepoint: 0 to 1 hour after coc. Method of measurement: Microscope.;Number of Zygotes. Timepoint: 16 to 18 hours after in vitro fertilization. Method of measurement: Microscope.;Total number of embryos obtained. Timepoint: Third day after in vitro fertilization. Method of measurement: Microscope.;Number of embryos transferred. Timepoint: 3 to 5 days after in vitro fertilization. Method of measurement: Microscope.;Checking the quality of the obtained embryos. Timepoint: Third or fifth day after in vitro fertilization. Method of measurement: Microscope.;Ratio of the number of eggs to the obtained follicles. Timepoint: Day of egg retrieval. Method of measurement: Microscope.;Fertilization Rate. Timepoint: Day of egg retrieval. Method of measurement: Microscope.;Cleavage Rate. Timepoint: Day of egg retrieval. Method of measurement: Microscope.;Maturation Rate. Timepoint: Day of egg retrieval. Method of measurement: Microscope.;Chemical Pregnancy. Timepoint: 14 ± 1 day after embryo transfer. Method of measurement: Lab test.;Examination of pregnancy sac. Timepoint: 3 weeks after embryo transfer. Method of measurement: Ultrasound.;Clinical Pregnancy with FHR. Timepoint: 5 weeks after embryo transfer. Method of measurement: Ultrasound. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr.Behnaz Hedayatjoo
Behrad Gen CO
Outcome results
None listed