Incremental Clomiphene Citrate Doses in Successive Cycles and FSH, LH and Steroid Hormone Levels

Study Overview
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Brief Summary
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This study was planned to assess the initial and endogenous FSH, LH and steroid responses to incremental CC doses in successive ovulation induction cycles to treat anovulation in patients with unexplained infertility.

Detailed Description
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In the Bagcilar Research and Training Hospital Obstetrics and Gynecology department outpatient clinic for infertility, the basal gonadotropin and androgen levels are routinely measured. In unexplained infertility couples with normal ovarian reserves the first line drug used for ovulation induction is CC. The starting dose is 50mg/day and the treatment is started within the 2nd to the 5th days of the menstrual cycle and continued for 5 days. Starting on the 2nd-3rd day following the last dose of the drug, the follicular growth was monitored with the transvaginal ultrasound and blood levels of hormones including FSH, LH, estradiol, progesterone, androstenedione, testosterone, and dehydroepiandrosterone sulphate were measured every 2-3 days. In this follow-up, if no follicular growth was observed day21 of the cycle, the CC dose was increased to CC 100mg/day (2X1, 50mg). If follicular growth and ovulation is achieved with no concluding conception, the same dose of CC is used in the following 2-3 cycles. When a maximum number of 2 dominant follicles are obtained ovulation is triggered with recombinant human chorionic gonadotropin (rhCG) and timed coit or intrauterine insemination is conducted.

Official Title
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The Effect of Incremental Clomiphene Citrate(CC) Doses in Successive Induction Cycles on the Endogenous Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and Steroid Hormone Responses to Treatment

Conditions
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Unexplained Infertility, Ovulation Disorder

Intervention / Treatment
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* Drug: Clomiphene Citrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20-35 years of age unexplained infertility first-line treatment Normal or increased ovarian reserve lack of ovulatory response to CC 50mg for 5 days Exclusion Criteria: Male factor Tubal Factor Severe endometriosis Previous ovarian surgery

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clomiphene citrate group 1<br>Clomiphene citrate dose 50mg/day for 5 days starting on cycle day (2-4). | Drug: Clomiphene Citrate<br>* Clomiphene citrate used in incremental doses in nonresponsive cases.<br>* Other names: CC;|
| Active Comparator: Clomiphene citrate group 2<br>Non-responsive to ovulation induction with Clomiphene Citrate with dose:50mg/day; and treated with dose:100mg/day in the succeeding cycle for 5 days, starting on cycle day (2-4). | Drug: Clomiphene Citrate<br>* Clomiphene citrate used in incremental doses in nonresponsive cases.<br>* Other names: CC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the endogenous blood levels of FSH, LH in successive cycles | FSH (mIU/ml), LH (mIU/ml) blood levels measured with Enzyme-Linked ImmunoSorbent Assay (ELISA) tests. | Menstrual cycle at day 3 and day 9 and the trigger day respectively (each cycle is 28 days | 
| Changes in the endogenous blood levels of steroids (including Androstenedione, Progesterone, Testosterone, estradiol) in successive cycles | Blood levels of steroids: Androstenedione (ng/ml), Progesterone (ng/ml), Testosterone (ng/ml), estradiol (pg/ml) measured with ELISA tests. | Menstrual cycle at day 3 and day 9 and the trigger day respectively (each cycle is 28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| conception rate | beta-hCG (IU/L)measured with ELISA. | 15-20 days following intrauterine insemination. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infertility, unexplained infertility, ovulation induction, clomiphene citrate