• Female infertility associated with anovulation. Hypopituitarism
Conditions
Interventions
Intervention 1: Intervention: Patients receive treatment with Gonal-F (starting dose 150 IU subcutaneously once daily and from day 2-3 according to the ovarian response) and Luveris (fixed dose of 75
Treatment - Drugs
Intervention: Patients receive treatment with Gonal-F (starting dose 150 IU subcutaneously once daily and from day 2-3 according to the ovarian response) and Luveris (fixed dose of 75 IU subcutaneousl
Control: Patients receive treatment with Gonal-F (starting dose 150 IU subcutaneously once daily and from day 2-3 according to the ovarian response) and Luveris (fixed dose of 75 IU subcutaneously onc
Sponsors
Royan Institute
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Have a clinical history of hypogonadotropic hypogonadism, and laboratory test result comply with diagnosis of hypogonadotropic hypogonadism; Have discontinued gonadotropins or gonadotropin releasing hormone or estrogen-progesterone replacement therapy at least one month before the study; Have primary or secondary amenorrhea; Serum LH and FSH <5.0 IU/l and oestradiol <100 pg/ml before initiation of treatment; Have a negative progesterone challenge test; Normal serum concentrations of thyroid stimulating hormone (TSH), prolactin and testosterone within 6 months before the start of study; Have given written informed consent prior to any study related procedure Exclusion Criteria: The other causes of infertility; History of ovarian hyper stimulation syndrome; Abnormal gynecological bleeding of undetermined origin; Previous or current hormone dependent tumor
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number and size of follicles. Timepoint: Before injection of hCG. Method of measurement: Sonography.;Endometrial thickness. Timepoint: Day of injection of hCG. Method of measurement: Sonography.;The number of oocytes retrieved. Timepoint: 34-36 hours after hCG injection. Method of measurement: Sonography. | — |
Secondary
| Measure | Time frame |
|---|---|
| Fertilization. Timepoint: 2-3 days before the embryo transfer. Method of measurement: observation of 2 pro-nuclei (2PN).;Biochemical pregnancy. Timepoint: 2 weeks after embryo transfer. Method of measurement: BhCG test.;Clinical pregnancy. Timepoint: 4-6 weeks after embryo transfer. Method of measurement: Ultrasound visualization of a gestational sac.;Implantation. Timepoint: 4-6 weeks after embryo transfer. Method of measurement: Number of gestational sacs by Sonography. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactTahereh Madani
Royan Institute
Outcome results
None listed