A Phase 3 interventional study of clomiphene citrate and clomiphene citrate in Ovulatory Dysfunction, Anovulation and Ovulation Induction, sponsored by University of Oklahoma. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2018-01-08.
Sponsored by University of Oklahoma · Phase 3, Interventional, and Treatment
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.
75 studies on the registry are indexed under Anovulation; 7 are open to participants now.
This study's enrollment of 120 is above the median of 80 across 52 interventional studies indexed under Anovulation.
Browse Anovulation studies →University of Oklahoma is the lead sponsor of 432 studies on the registry; 100 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
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Semen analysis of male partner with > 15 million motile sperm on semen analysis.
Exclusion Criteria:
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The human immunodeficiency virus, which weakens the immune system.
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HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: clomiphene citrate
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.
Drug: 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.
Also known as: Clomid
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.
Also known as: Clomid
Time to Ovulation With Each Protocol
We hypothesized that time to ovulation would be shorter with stair-step protocol vs. traditional.
Time frame: 5 years
Rate of Ovulation
Rate of ovulation with each dose of clomid within each protocol
Time frame: 5 years
Delivery Outcomes
Proportion of participants that delivered a baby based on which protocol they were randomized to.
Time frame: 5 years
Recruitment was in the infertility clinic.
| Milestone | Traditional Administration | Stair-Step Administration |
|---|---|---|
| Started | 60 | 60 |
| Completed | 60 | 60 |
| Not completed | 0 | 0 |
We hypothesized that time to ovulation would be shorter with stair-step protocol vs. traditional.
| days | Traditional Administration | Stair-Step Administration |
|---|---|---|
| Time to Ovulation With Each Protocol | 31.1 ± 3.5 | 21.5 ± 0.9 |
Rate of ovulation with each dose of clomid within each protocol
| Participants | Traditional Protocol | Stair-Step Protocol |
|---|---|---|
| Clomid 50mg | 45 | 26 |
| Clomid 100mg | 7 | 18 |
| Clomid 150mg | 1 | 10 |
| Clomid No Response | 7 | 6 |
Proportion of participants that delivered a baby based on which protocol they were randomized to.
| Participants | Traditional Protocol | Stair-Step Protocol |
|---|---|---|
| Delivery Outcomes | 21 | 21 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Traditional Administration | — | 2/60 (3.3%) | 60/60 (100%) |
| Stair-Step Administration | — | 3/60 (5%) | 60/60 (100%) |
| Event | Traditional Administration | Stair-Step Administration |
|---|---|---|
| Birth DefectCongenital, familial and genetic disorders | 0/60 | 2/60 |
| Blurry Vision/Double VisionEye disorders | 1/60 | 1/60 |
| GallstonesHepatobiliary disorders | 1/60 | 0/60 |
| Event | Traditional Administration | Stair-Step Administration |
|---|---|---|
| HeadachesNervous system disorders | 34/60 | 27/60 |
| Vasomotor Flushes (hot flashes)Endocrine disorders | 32/60 | 30/60 |
| Mood SwingsPsychiatric disorders | 32/60 | 27/60 |
| Pelvic DiscomfortReproductive system and breast disorders | 29/60 | 18/60 |
| NauseaGastrointestinal disorders | 26/60 | 15/60 |
| Breast tendernessReproductive system and breast disorders | 21/60 | 21/60 |
| InsomniaGeneral disorders | 15/60 | 7/60 |
| NervousnessPsychiatric disorders | 12/60 | 3/60 |
| Weight gainEndocrine disorders | 11/60 | 6/60 |
| Light sensitivityEye disorders | 7/60 | 1/60 |
A total of 120 patients (60 stair-step, 60 traditional) were randomized.
| Age, Continuous(years) | Traditional Administration | Stair-Step Administration | Total |
|---|---|---|---|
| Mean | 27.88 ± 4.95 | 29.37 ± 3.96 | 28.65 ± 4.45 |
| Sex: Female, Male(Participants) | Traditional Administration | Stair-Step Administration | Total |
|---|---|---|---|
| Female | 60 | 60 | 120 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Traditional Administration | Stair-Step Administration | Total |
|---|---|---|---|
| American Indian or Alaska Native | 4 | 0 | 4 |
| Asian | 4 | 2 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 3 | 9 |
| White | 46 | 55 | 101 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
The record gives a start of Oct 2009, a primary completion of Nov 2015 and a completion of Nov 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2018, 2 years 2 months after primary completion.
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Studies of the drug tested here: Clomiphene