The Effect of LH-Priming During Early Follicular Phase in IVF Treatment.

Study Overview
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Brief Summary
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To evaluate the effect of LH-activity supplementation during the early follicular phase in GnRHa down-regulated women undergoing IVF in terms of S-Estradiol levels on hCG day by comparing different combinations with HP-HMG and r-FSH.

Official Title
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The Effect of LH-Priming During Early Follicular Phase on Ovarian Response and Pregnancy Outcome in GnRHa Down-Regulated Women, Stimulated With Exogenous Gonadotrophins in IVF Treatment

Conditions
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Infertility

Intervention / Treatment
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* Drug: MENOPUR; GONAL-F


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females between the ages of 18- 38 years (both included) at the time of randomisation Patients for whom treatment with gonadotrophins and GnRH agonist (long protocol) in IVF setting is considered appropriate according to the criteria of the participating centre Infertility for at least 1 year before randomisation (except for tubal infertility) A maximum of two previous consecutive unsuccessful IVF cycles (i.e. not resulting in an ongoing pregnancy 25- 34 days of menstruation cycle Body mass index (BMI) < 29 kg/m2 Exclusion Criteria: Any clinically significant systemic disease (e.g., insulin dependent diabetes) Endocrine or metabolic abnormalities (pituitary, adrenal, thyroid, pancreas, liver, or kidney) which can compromise participation in the study Any concomitant medications that would interfere with evaluation of study medications. Specifically, any non-study hormonal therapy (except for thyroid medication), prostaglandin inhibitors (NSAIDs, including aspirin) and psychotropic agents (phenothiazine's, major tranquillisers) at the time of study entry. Note: these medications are disallowed for the study duration. Presence of clinically significant uterine fibroids Undiagnosed vaginal bleeding Tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus Pregnancy, lactation or contraindication to pregnancy - must be confirmed by negative urinary pregnancy test at randomisation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MENOPUR; GONAL-F|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulatory levels of Estradiol on the day of hCG |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of follicles as well as the numbers of follicles <10mm, 10-14 mm, >14mm day during gonadotrophin treatment and at the end of stimulation prior to hCG injection |  |  | 
| E2 per follicle >14 mm |  |  | 
| Total number of oocytes retrieved |  |  | 
| fertilization rate |  |  | 
| serum hCG > 10 IU/l on day 12-14 after embryo transfer |  |  | 
| implantation rate |  |  | 
| transferable embryos |  |  | 
| Clinical pregnancy rate |  |  | 
| Ongoing pregnancy rate |  |  | 
| embryo quality |  |  | 
| Serum; LH, FSH, Androstenedione, Progesterone, hCG and Inhibin-B. Progesterone seven days after ET day |  |  | 
| Intra follicular levels of; endocrine parameters |  |  | 
| Endometrial thickness; hCG day (minus 0-2 days) |  |  | 
| Total gonadotrophin dose administered |  |  |