Phase 3
Completed N=120
Traditional Clomiphene Citrate Administration vs. Stair-step Approach
Ovulatory Dysfunction · Anovulation · Ovulation Induction
Source: ClinicalTrials.gov NCT01008319 ↗
Enrolled (actual)
120
Serious AEs
4.2%
Results posted
Jan 2018
Primary outcomePrimary: Time to Ovulation With Each Protocol — 31.1; 21.5 days
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Ovulation With Each Protocol |
31.1; 21.5 | — |
| SECONDARY Rate of Ovulation |
45; 26; 7; 18; 1; 10 | — |
| SECONDARY Delivery Outcomes |
21; 21 | — |
Eligibility Criteria
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.
- NOTE: Must be willing to travel to the Oklahoma City area for treatment.
Exclusion Criteria
- Failure to spontaneously menstruate or to menstruate following progestin administration
- Allergy or intolerance to the side effects of clomiphene citrate, hCG (human chorionic gonadotropins), or medroxyprogesterone acetate (Provera).
- Known anatomical defect affecting the uterine cavity including submucosal fibroids or endometrial polyps.
- Know tubal hydrosalpinx or risk factors for tubal obstruction
- Known liver dysfunction
- Known or suspected androgen secreting tumor, cushings disease, or adrenal hyperplasia (congenital or adult onset)
- Ovarian cyst > 20mm or endometrial lining >6 mm on trans-vaginal baseline ultrasound.
- Stage III or IV endometriosis
- Decreased ovarian reserve as evidenced by antral follicle count less than 6 by Transvaginal ultrasound or a cycle-day-3 serum FSH of > 10 uIU/ml.
- Positive HIV in either the female patient or her partner.
Data sourced from ClinicalTrials.gov (NCT01008319). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.