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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Infertility

Intervention / Treatment
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* Drug: Lutropin alfa
* Drug: Follitropin alfa and Lutropin alfa


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Luveris<br>Evaluation the effect of Luveris protocol on Induction of ovulation in Patients with Hypogonadotropic Hypogonadism | Drug: Lutropin alfa<br>* Administration of Gonal-F or recombinant Follicle Stimulating Hormone (rFSH)<br>* Other names: Follitropin alfa: Gonal-F or recombinant Follicle Stimulating Hormone (rFSH);|
| Active Comparator: Gonal-F& Luveris<br>Evaluation the effect of Gonal-F& Luveris protocols of Induction of ovulation in Patients with Hypogonadotropic Hypogonadism | Drug: Follitropin alfa and Lutropin alfa<br>* Administration of (rFSH) and (rLH)<br>* Other names: Lutropin alfa: Luveris or Recombinant Luteinizing Hormone (rLH);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gonal-F Luveris Assisted Reproductive Technology Hypogonadotropic Hypogonadism