Clinical trial NCT02140515: Comparison of Assisted Reproductive Technology (ART) Outcomes Between Two Protocols of Induction of Ovulation in Patients With Hypogonadotropic Hypogonadism
Official title: Comparison of Assisted Reproductive Technology (ART) Outcomes Between Two Protocols of Induction of Ovulation by Using Recombinant Luteinizing Hormone (rLH) and Recombinant Follicle Stimulating Hormone (rFSH) in Patients With Hypogonadotropic Hypogonadism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infertility
Keywords: Gonal-F Luveris Assisted Reproductive Technology Hypogonadotropic Hypogonadism
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2014-05-16
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: In this single blind randomized clinical trial, 90 women with a clinical history of hypogonadotrophic hypogonadism who stopped any treatment with gonadotrophins \>1 month before study, with a negative progesterone challenge test, low serum gonadotrophins (Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) less than 5.0 IU/l) and oestradiol (less than 100 pg/ml) and normal serum concentrations of thyroid stimulating hormone (TSH), testosterone and prolactin within 6 months before the start of treatment are studied in the Royan Institute. Other causes of infertility are excluded from the study. All patients receive treatment with recombinant follicle stimulating hormone (Gonal-F) and recombinant luteinizing hormone (Luveris). When at least one follicle reaches 14 mm in diameter, 4mg/day oestradiol is administered and patients are randomly divided into two groups: Luveris alone (intervention group) and continued treatment with both drugs Gonal-F and Luveris (control group). When at least one follicle detects a mean diameter of ≥18 mm and serum estradiol level reaches 500-2000 pg/ml, ovarian stimulation is stopped and injection of 10000 IU Human Chorionic Gonadotrophin (hCG) is administrated.

At the end, the number and size of ovarian follicles, endometrial thickness on the day of injection of Human Chorionic Gonadotrophin (hCG), the number of oocytes retrieved, the number of good quality embryos, chemical and clinical pregnancy rate, fertilization rate and implantation rate will be compared between the two groups.

Eligibility 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

Primary outcomes:
measure: number of follicles
timeFrame: baseline
measure: Size of follicle
timeFrame: baseline
measure: Endometrial thickness
timeFrame: 1day
Secondary outcomes:
measure: number of oocytes retrieved
timeFrame: 3 days
measure: Fertilization rate
timeFrame: 2 days
measure: Biochemical pregnancy rate
timeFrame: 2 weeks
measure: Clinical pregnancy rate
timeFrame: 4 weeks
measure: Implantation rate
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
name: Tahereh Madani, MD
role: STUDY_DIRECTOR
affiliation: Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Centre, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
name: Seyedeh Masoumeh Moosavi Sadat, MSc
role: PRINCIPAL_INVESTIGATOR
References: