Comparison of Assisted Reproductive Technology (ART) Outcomes Between Two Protocols of Induction of Ovulation in Patients With Hypogonadotropic Hypogonadism

• Status: Unknown status
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

We wanted to compare the Assisted Reproductive Technology (ART) outcomes between two protocols of induction of ovulation in patients with Hypogonadotropic Hypogonadism. In the beginning, all patients receive Recombinant Follicle Stimulating Hormone (Gonal-F) and Recombinant Luteinizing Hormone (Luveris). When at least one follicle reaches 14 mm in diameter, Luveris alone is administered for group A and both drugs Gonal-F and Luveris for group B. Finally Assisted Reproductive Technology (ART) results are compared between the two groups.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royan Institute
• Treatments: Follicle Stimulating Hormone; Hormones

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 Luteinizing Hormone (LH) and Follicle Stimulating Hormone (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

• Be willing and able to comply with the protocol for the duration of the 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