Clinical trial · Interventional
Clomiphene Stair-Step Protocol for Ovulation Induction in Women With Polycystic Ovarian Syndrome
Study of Stair-step Clomiphene Protocol for Ovulation Induction in Women With Polycystic Ovarian Syndrome (PCOS) Compared to Traditional Protocol.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of our study is to evaluate the efficacy of the clomiphene stair-step protocol to induce ovulation in women with polycystic ovarian syndrome (PCOS) compared to traditional protocol. Methods:This was a randomized controlled clinical trial at the Fertility clinic of Al sadder teaching hospital at Al- Najaf city, Iraq . It included 140 women who met all of the inclusion criteria, they were divided into two groups; 65 patients for the stair step protocol and 75 patients for the traditional protocol.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| clomiphene | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Study of Stair-step Clomiphene Protocol
- description
- 50 mg clomiphene given for 5 days beginning on day 2 of the cycle. Tv USS done at days 11-14. When there is no response (no follicle \>10 mm), 100 mg clomiphene is initiated immediately for 5 days, and U/S is repeated 1 week after the first tvUSS at day 21. If there is no response, another 150 mg clomiphene is initiated immediately for 5 days and U/S is performed 1week after the second U/S (day28). Ovulation for the stair-step cycles was confirmed by folliculometry (follicle tracing) by tvUSS.
- interventionNames
- Drug: clomiphene
- type
- ACTIVE_COMPARATOR
- label
- Traditional Protocol.
- description
- Clomiphene medication was initiated at day two of the cycle. The starting dose was 50 mg/day for 5 consecutive days. In case of absent response, the patient was treated with 10 mg medroxyprogesterone acetate (MPA) for10 days. Daily doses of clomiphene citrate were increased by 50 mg in the next cycle up to 3 treatment cycle. In each cycle monitoring of follicular growth was done by tvUSS at day 11-14 of each cycle. First ovulation was used as the endpoint and the duration of follow-up was three treatment cycles (up to 150mg). Ovulation was assessed by tvUSS monitoring of follicle growth.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 34 Years
Show eligibility criteria text
Inclusion Criteria:Female in the reproductive age who is subfertile with the diagnosis of polycystic ovarian syndrome, serum FSH≤10 mIU/ml with spontaneous menses or positive bleeding response to progestagen withdrawal. \- Exclusion Criteria:Male factor (moderate to severe) infertility, bilateral tubal blockage diagnosed by hystrosalpingographgy or laparoscopy and patients on metformin or other medication. \-
References
Publications (2)
- BACKGROUNDclomiphene protocol in polycystic ovarian syndrome: Hurst et al.
- RESULTHurst BS, Hickman JM, Matthews ML, Usadi RS, Marshburn PB. Novel clomiphene "stair-step" protocol reduces time to ovulation in women with polycystic ovarian syndrome. Am J Obstet Gynecol. 2009 May;200(5):510.e1-4. doi: 10.1016/j.ajog.2008.10.031. Epub 2008 Dec 27. PMID 19114272