Clinical trial NCT03178500: Clomiphene Citrate Stair-Step Protocol
Official title: Clomiphene Citrate Stair-step Protocol for Ovulation Induction in Women With Polycystic Ovarian Syndrome: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary
Keywords: clomiphene citrate
stair- step
poly cystic ovary
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A RCT will be conducted to compare the traditional clomiphene citrate regimens for ovulation induction with the stair-step protocol. Sixty women will be included after obtaining their written informed consent and will be randomized into either of the 2 groups.

Detailed description: This study is a randomized clinical trial (RCT) will be conducted in Ain Shams University maternity hospital at infertility clinic within a period of 6-8 months.

All patient are previously diagnosed as PCOs according to the Rotterdam conference of 2003.

All patients will be devided according to computer based program into two groups First group: Patients with traditional protocol

Traditional protocol:

Clomiphene citrate (clomid) (50mg) will be given for 5 days (days 3-7). Transvaginal ultrasound from 9th-20th every other day if ovulation occur the patient will be excluded if no ovulation, we will wait for the next menses and increase the dose to (100mg). if no ovulation occurred increase the dose to (150mg) in the next cycle if no ovulation increase the dose to (200mg) TVUS from 9th-20th ovary other day. If no ovulation we will wait for next cycle and increase the dose to (250mg) and so till 6 cycles .

Second group: Patient with stair step protocol Follicular development will be monitored using transvaginal ultrasound at 11-14 day after (50mg) clomiphene for 5 days if there is no response (no follicle \>10mm), so, (100mg) clomiphene will be initiated immediately for 5 days and ultrasound will be repeated 1 week after the first ultrasound. If there is no response, (150mg) clomiphene will be initiated immediately for another 5 days and TV/US will be performed 1 week after the second TV/US .

Eligibility criteria: Inclusion Criteria:

* Age between 20-35 years.

  * Body mass index (BMI/m2) 26-35 kg/m2
  * Normal hystrosalpingogram (HSG).
  * Normal Prolactin level.
  * Normal semen analysis.

Exclusion Criteria:

* - They underwent ovarian drilling.
* Other factors infertility.
* AUTOimmune diseases as thyroid disorders and systemic lupus erythematosus.

Primary outcomes:
measure: Occurrence of the ovulation by transvaginal ultrasound
timeFrame: 20 days
Secondary outcomes:
measure: time to achieve ovulation
timeFrame: 20 days
measure: dose of clomiphene to achieve ovulation
timeFrame: 20 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
Study officials:
affiliation: Assistant Proffesor
name: Adel S Salah El-Din, MD
role: STUDY_DIRECTOR
References: