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Comparison of ART Outcomes between Two Protocols of Induction of ovulation in Patients with Hypogonadotropic Hypogonadism

Phase 4
Conditions
•Female infertility associated with anovulation.
Hypopituitarism
Registration Number
IRCT201312251141N16
Lead Sponsor
Royan Institute
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
90
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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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.
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