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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Luveris | Active Comparator | Evaluation the effect of Luveris protocol on Induction of ovulation in Patients with Hypogonadotropic Hypogonadism |
|
| Gonal-F& Luveris | Active Comparator | Evaluation the effect of Gonal-F& Luveris protocols of Induction of ovulation in Patients with Hypogonadotropic Hypogonadism |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lutropin alfa | Drug | Administration of Gonal-F or recombinant Follicle Stimulating Hormone (rFSH) |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of follicles | Evaluation thre number follicles before injection of Human Chorionic Gonadotrophin (hCG) | baseline |
| Size of follicle | Evaluation the size of follicle before injection of Human Chorionic Gonadotrophin (hCG) | baseline |
| Endometrial thickness | Evaluation the endometrial thickness at the day of injection of Human Chorionic Gonadotrophin (hCG) | 1day |
| Measure | Description | Time Frame |
|---|---|---|
| number of oocytes retrieved | Evaluation the number of oocytes retrieved 34-36 hours after Human Chorionic Gonadotrophin (hCG) injection | 3 days |
| Fertilization rate | Evaluation the fertilization rate 2-3 days before the embryo transfer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nasser Aghdami, MD,PhD | Contact | (+98)2123562000 | 516 | nasser.aghdami@royaninstitute.org |
| Leila Arab, MD | Contact | (+98)2123562000 | 414 | Leara91@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hamid Gourabi, PhD | Head of Royan Institute | Study Chair |
| Tahereh Madani, MD | Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royan Institute | Recruiting | Tehran | Iran |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Follitropin alfa and Lutropin alfa | Drug | Administration of (rFSH) and (rLH) |
|
|
| 2 days |
| Biochemical pregnancy rate | Evaluation the biochemical pregnancy rate 2 weeks after embryo transfer | 2 weeks |
| Clinical pregnancy rate | Evaluation the clinical pregnancy rate 4-6 weeks after embryo transfer | 4 weeks |
| Implantation rate | Evaluation the implantation rate 4-6 weeks after embryo transfer. | 4 weeks |
| Seyedeh Masoumeh Moosavi Sadat, MSc | Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Centre, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran | Principal Investigator |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D037101 | Luteinizing Hormone, beta Subunit |
| D015292 | Glycoprotein Hormones, alpha Subunit |
| C571801 | follitropin alfa |
| D007986 | Luteinizing Hormone |
| ID | Term |
|---|---|
| D006065 | Gonadotropins, Pituitary |
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006063 | Chorionic Gonadotropin |
| D005640 | Follicle Stimulating Hormone |
| D013972 | Thyrotropin |
| D010926 | Placental Hormones |
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