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The purpose of this study is to compare the length of time to achieve ovulation and pregnancy with a traditional protocol administration of clomiphene citrate versus a stair step administration.
Our hypothesis is by using a stair-step approach in which a period is not induced between administrations of escalating doses of clomiphene citrate, the time to ovulation and pregnancy may be reduced.
The traditional administration of clomiphene citrate for ovulation induction involves taking clomiphene citrate for 5 days. If ovulation does not occur within 14 days, a progestin pill (such as Provera) is prescribed for 10 days to induce a period (which normally occurs within 1 week of stopping the pill). Then a higher dose of clomiphene citrate will be prescribed.
The stair-step administration of clomiphene citrate for ovulation induction also involves taking clomiphene citrate for 5 days. In contrast, if ovulation does not occur within 7-9 days, a progestin pill (such as Provera) would NOT be taken to induce a period. The dose of clomiphene will then be increased. Therefore, this would do away with the 10 days of taking the progestin pill, and also do away with waiting for a period (usually 3 to 7 days) for a total of up to a 20 day difference between clomiphene citrate dosing cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Administration | Active Comparator | The traditional approach to ovulation induction with clomiphene citrate involves administration of 50mg/day for five days (starting on cycle day 3, 4, or 5). If ovulation does not occur then a progestin is prescribed to induce menses (which occurs within one week of stopping the progestin) and then a higher dose of medication is used in the next cycle. |
|
| Stair-Step Administration | Experimental | The stair-step protocol the dose of clomiphene citrate would be increased without administering progestin and inducing a period. This would eliminate the days of progestin (10 days) and the waiting for the period (usually 3 to 7 days) and finally waiting to start clomiphene citrate on cycle day 3 at the earliest (3 more days) for a total of up to 20 days difference for the 100 mg dose of clomid. If they did not ovulate on 100mg, then the process repeats and another 20 days before they start 150mg. Therefore, the time to ovulation and pregnancy may be reduced, and hopefully pregnancy, by using the stair-step protocol. This method utilizes ultrasound monitoring for follicle development before increasing the dose of clomiphene citrate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clomiphene citrate | Drug | Clomiphene citrate 50 mg for 5 days starting on cycle day 5. Transvaginal ultrasound between cycle days 11 to 14 to determine if there is a dominant follicle. If NO dominant follicle present, another ultrasound and blood draw (to test progesterone level) will be done one week later to confirm no response to the medication dose. Medroxyprogesterone acetate (Provera) 10 mg per day for 10 days. Increased dose of clomiphene citrate for 5 days starting on cycle day 5. This process will be repeated at increased doses of clomiphene citrate (100 mg and 150 mg) until a dominant follicle(s) is present. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Ovulation With Each Protocol | We hypothesized that time to ovulation would be shorter with stair-step protocol vs. traditional. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Ovulation | Rate of ovulation with each dose of clomid within each protocol | 5 years |
| Delivery Outcomes | Proportion of participants that delivered a baby based on which protocol they were randomized to. |
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Inclusion Criteria:
Ovulatory dysfunction as evidenced by mid-luteal progesterone less then 3ng/dL, non-biphasic basal body temperature charting, or menstrual history of cycles > 35 days.
Female patients 18 to 45 years old
Six months or greater of unprotected intercourse without pregnancy.
Normal TSH and prolactin serum levels
Semen analysis of male partner with > 15 million motile sperm on semen analysis.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| LaTasha Craig, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73013 | United States |
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Recruitment was in the infertility clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Traditional Administration | The traditional approach to ovulation induction with clomiphene citrate involves administration of 50mg/day for five days (starting on cycle day 5). If ovulation does not occur by day 21 then a progestin is prescribed to induce menses (which occurs within one week of stopping the progestin) and then a higher dose of medication is used in the next cycle. This process will be repeated at increased doses of clomiphene citrate (100 mg and 150 mg). |
| FG001 | Stair-Step Administration | The stair-step protocol the dose of clomiphene citrate would be increased without administering progestin and inducing a period. This method utilizes ultrasound monitoring for follicle development before increasing the dose of clomiphene citrate. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 120 patients (60 stair-step, 60 traditional) were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Traditional Administration | |
| BG001 | Stair-Step Administration | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Ovulation With Each Protocol | We hypothesized that time to ovulation would be shorter with stair-step protocol vs. traditional. | Posted | Mean | Standard Error | days | 5 years |
|
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Questionnaire were administered at each appointment for ultrasound evaluation. They assessed none, mild, moderate or severe symptoms including: hot flashes, mood swings, breast tenderness, pelvic discomfort, nausea, vomiting, blurry vision, light sensitivity, headache, decreased urination, weight gain, insomnia, nervousness and leg pain.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Traditional Administration | The traditional approach to ovulation induction with clomiphene citrate involves administration of 50mg/day for five days (starting on cycle day 3, 4, or 5). If ovulation does not occur then a progestin is prescribed to induce menses (which occurs within one week of stopping the progestin) and then a higher dose of medication is used in the next cycle. clomiphene citrate: Clomiphene citrate 50 mg for 5 days starting on cycle day 5. Transvaginal ultrasound between cycle days 11 to 14 to determine if there is a dominant follicle. If NO dominant follicle present, another ultrasound and blood draw (to test progesterone level) will be done one week later to confirm no response to the medication dose. Medroxyprogesterone acetate (Provera) 10 mg per day for 10 days. Increased dose of clomiphene citrate for 5 days starting on cycle day 5. This process will be repeated at increased doses of clomiphene citrate (100 mg and 150 mg) until a dominant follicle(s) is present. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Birth Defect | Congenital, familial and genetic disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vasomotor Flushes (hot flashes) | Endocrine disorders | Non-systematic Assessment | Hot Flashes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| LaTasha Craig, MD | University of Oklahoma | 405-271-8787 | latasha-craig@ouhsc.edu |
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| ID | Term |
|---|---|
| D000858 | Anovulation |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D002996 | Clomiphene |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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|
|
| clomiphene citrate | Drug | Clomiphene citrate 50 mg for 5 days starting on cycle day 5. Transvaginal ultrasound between cycle days 11 to 14 to determine if there is a dominant follicle. If NO dominant follicle present, a blood draw (to test progesterone level) will be done. Increased dose of clomiphene citrate for 5 days starting that day. A repeat transvaginal ultrasound in one week to determine if there is a dominant follicle. This process will be repeated at increased doses of clomiphene citrate (100 mg and 150 mg) until a dominant follicle(s) is present. |
|
|
| 5 years |
Total of all reporting groups
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Stair-Step Administration | The stair-step protocol the dose of clomiphene citrate would be increased without administering progestin and inducing a period. This would eliminate the days of progestin (10 days) and the waiting for the period (usually 3 to 7 days) and finally waiting to start clomiphene citrate on cycle day 3 at the earliest (3 more days) for a total of up to 20 days difference for the 100 mg dose of clomid. If they did not ovulate on 100mg, then the process repeats and another 20 days before they start 150mg. Therefore, the time to ovulation and pregnancy may be reduced, and hopefully pregnancy, by using the stair-step protocol. This method utilizes ultrasound monitoring for follicle development before increasing the dose of clomiphene citrate. |
|
|
| Secondary | Rate of Ovulation | Rate of ovulation with each dose of clomid within each protocol | Proportion of subjects that ovulated at each dose of Clomid based on which protocol they were randomized to. | Posted | Count of Participants | Participants | 5 years |
|
|
|
| Secondary | Delivery Outcomes | Proportion of participants that delivered a baby based on which protocol they were randomized to. | Number of participants randomized to each arm. | Posted | Count of Participants | Participants | 5 years |
|
|
|
| 2 |
| 60 |
| 60 |
| 60 |
| EG001 | Stair-Step Administration | The stair-step protocol the dose of clomiphene citrate would be increased without administering progestin and inducing a period. This would eliminate the days of progestin (10 days) and the waiting for the period (usually 3 to 7 days) and finally waiting to start clomiphene citrate on cycle day 3 at the earliest (3 more days) for a total of up to 20 days difference for the 100 mg dose of clomid. If they did not ovulate on 100mg, then the process repeats and another 20 days before they start 150mg. Therefore, the time to ovulation and pregnancy may be reduced, and hopefully pregnancy, by using the stair-step protocol. This method utilizes ultrasound monitoring for follicle development before increasing the dose of clomiphene citrate. | 3 | 60 | 60 | 60 |
| Blurry Vision/Double Vision | Eye disorders | Non-systematic Assessment |
|
| Gallstones | Hepatobiliary disorders | Non-systematic Assessment |
|
|
| Mood Swings | Psychiatric disorders | Non-systematic Assessment | mood irritability |
|
| Breast tenderness | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Pelvic Discomfort | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Blurry Vision/Double Vision | Eye disorders | Non-systematic Assessment |
|
| Light sensitivity | Eye disorders | Non-systematic Assessment |
|
| Headaches | Nervous system disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Decreased urination frequency | Renal and urinary disorders | Non-systematic Assessment |
|
| Weight gain | Endocrine disorders | Non-systematic Assessment |
|
| Insomnia | General disorders | Non-systematic Assessment |
|
| Nervousness | Psychiatric disorders | Non-systematic Assessment |
|
| Leg pain/leg swelling | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| Clomid 150mg |
|
| Clomid No Response |
|